14
octreotide acetate INJECTION Rx only 50 mcg/mL octreotide acetate INJECTION 50 mcg/mL; Each mL contains: octreotide (as acetate) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50 mcg Inactive ingredients lactic acid, USP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.4 mg mannitol, USP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45 mg sodium bicarbonate, USP . . . . . . . . . . . . . . . . . . . . . . . . qs to pH 4.2 ± 0.3 water for injection, USP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . qs to 1 mL See package insert for dosage and administration information. Storage: Refrigerate at 2°C to 8°C (36°F to 46°F); protect from light. At room temperature, (20°C to 30°C or 70°F to 86°F), Sandostatin is stable for 14 days if protected from light. Instructions for Use One-point-cut ampul with cut below colored point To open, hold as shown with thumb above point and snap off backwards Manufactured by: Novartis Pharma Stein AG Schaffhauserstrasse CH-4332 Stein, Switzerland Distributed by: Novartis Pharmaceuticals Corporation East Hanover, New Jersey 07936 ©Novartis 1256727 NDC 0078-0180-01 Unit Dose Package NDC 0078-0180-01 Unit Dose Package NDC 0078-0180-01 Unit Dose Package For Subcutaneous Injection 10 Ampuls/1 mL size 50 mcg/mL 10 Ampuls/1 mL size octreotide acetate INJECTION NDC 0078-0180-01 Unit Dose Package 50 mcg/mL 10 Ampuls/1 mL size Please open here Please open here EXP. LOT 120 x 105 x 20.5 1256727 US 1256727

INJECTION - Food and Drug Administration · INJECTION 5,000 mc g/ 5 mL (1,000 mcg/mL) FOR SUBCUTANEOUS INJECTION 5,000 mc g/ 5 mL ... Water for Injection, USP.....qs to …

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Page 1: INJECTION - Food and Drug Administration · INJECTION 5,000 mc g/ 5 mL (1,000 mcg/mL) FOR SUBCUTANEOUS INJECTION 5,000 mc g/ 5 mL ... Water for Injection, USP.....qs to …

octreotide acetateINJECTION

Rx only

50 mcg/mL

octre

otid

e ac

etat

eIN

JEC

TIO

N

50 mcg/mL; Each mL contains: octreotide (as acetate) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50 mcgInactive ingredientslactic acid, USP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.4 mgmannitol, USP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45 mgsodium bicarbonate, USP . . . . . . . . . . . . . . . . . . . . . . . . qs to pH 4.2 ± 0.3water for injection, USP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . qs to 1 mL See package insert for dosage and administration information.

Storage: Refrigerate at 2°C to 8°C (36°F to 46°F); protect from light.At room temperature, (20°C to 30°C or 70°F to 86°F), Sandostatin is stable for 14 days if protected from light.

Instructions for Use

One-point-cut ampul with cut below colored point

To open, hold as shown with thumb above point and snap off backwards

Manufactured by: Novartis Pharma Stein AGSchaffhauserstrasseCH-4332 Stein, Switzerland

Distributed by:Novartis Pharmaceuticals CorporationEast Hanover, New Jersey 07936 ©Novartis 1256727

NDC 0078-0180-01Unit Dose Package

NDC 0078-0180-01Unit Dose Package

NDC

0078

-018

0-01

Unit

Dose

Pac

kage

For Subcutaneous Injection 10 Ampuls/1 mL size

50 m

cg/m

L 10

Am

puls/

1 m

L siz

eoctreotide acetate

INJEC

TION

NDC 0078-0180-01Unit Dose Package

50 mcg/m

L 10 Am

puls/1 mL size

Please open here Please open here

EXP.LOT

120 x 105 x 20.51256727US

1256727

Page 2: INJECTION - Food and Drug Administration · INJECTION 5,000 mc g/ 5 mL (1,000 mcg/mL) FOR SUBCUTANEOUS INJECTION 5,000 mc g/ 5 mL ... Water for Injection, USP.....qs to …

octreotide acetateINJECTION

Rx only

100 mcg/mL

octre

otid

e ac

etat

eIN

JEC

TIO

N

100 mcg/mL; Each mL contains: octreotide (as acetate) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100 mcgInactive ingredientslactic acid, USP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.4 mgmannitol, USP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45 mgsodium bicarbonate, USP . . . . . . . . . . . . . . . . . . . . . . . . qs to pH 4.2 ± 0.3water for injection, USP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . qs to 1 mL See package insert for dosage and administration information.

Storage: Refrigerate at 2°C to 8°C (36°F to 46°F); protect from light.At room temperature, (20°C to 30°C or 70°F to 86°F), Sandostatin is stable for 14 days if protected from light.

Instructions for Use

One-point-cut ampul with cut below colored point

To open, hold as shown with thumb above point and snap off backwards

Manufactured by: Novartis Pharma Stein AGSchaffhauserstrasseCH-4332 Stein, Switzerland

Distributed by:Novartis Pharmaceuticals CorporationEast Hanover, New Jersey 07936 ©Novartis 1256728

NDC 0078-0181-01Unit Dose Package

NDC 0078-0181-01Unit Dose Package

NDC

0078

-018

1-01

Unit

Dose

Pac

kage

For Subcutaneous Injection 10 Ampuls/1 mL size

100

mcg

/mL

10 A

mpu

ls/1

mL

size

octreotide acetateIN

JECTIO

N

NDC 0078-0181-01Unit Dose Package

100 mcg/m

L 10 Am

puls/1 mL size

Please open here Please open here

EXP.LOT

120 x 105 x 20.51256728US

Page 3: INJECTION - Food and Drug Administration · INJECTION 5,000 mc g/ 5 mL (1,000 mcg/mL) FOR SUBCUTANEOUS INJECTION 5,000 mc g/ 5 mL ... Water for Injection, USP.....qs to …

octreotide acetateINJECTION

Rx only

500 mcg/mL

octre

otid

e ac

etat

eIN

JEC

TIO

N500 mcg/mL; Each mL contains: octreotide (as acetate) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 500 mcgInactive ingredientslactic acid, USP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.4 mgmannitol, USP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45 mgsodium bicarbonate, USP . . . . . . . . . . . . . . . . . . . . . . . . qs to pH 4.2 ± 0.3water for injection, USP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . qs to 1 mL See package insert for dosage and administration information.Storage: Refrigerate at 2°C to 8°C (36°F to 46°F); protect from light.At room temperature, (20°C to 30°C or 70°F to 86°F), Sandostatin is stable for 14 days if protected from light.

Instructions for Use

One-point-cut ampul with cut below colored point

To open, hold as shown with thumb above point and snap off backwards

Manufactured by: Novartis Pharma Stein AGSchaffhauserstrasseCH-4332 Stein, Switzerland

Distributed by:Novartis Pharmaceuticals CorporationEast Hanover, New Jersey 07936 ©Novartis 1256731

NDC 0078-0182-01Unit Dose Package

NDC 0078-0182-01Unit Dose Package

NDC

0078

-018

2-01

Unit

Dose

Pac

kage

For Subcutaneous Injection 10 Ampuls/1 mL size

500

mcg

/mL

10 A

mpu

ls/1

mL

size

octreotide acetateIN

JECTIO

N

NDC 0078-0182-01Unit Dose Package

500 mcg/m

L 10 Am

puls/1 mL size

Please open here Please open here

EXP.LOT

120 x 105 x 20.51256731US

1256731

Page 4: INJECTION - Food and Drug Administration · INJECTION 5,000 mc g/ 5 mL (1,000 mcg/mL) FOR SUBCUTANEOUS INJECTION 5,000 mc g/ 5 mL ... Water for Injection, USP.....qs to …

Sandostatinoctreotide acetateINJECTION1,000 mcg/5 mL (200 mcg/mL)Total Volume 5 mL Multi-Dose VialEach mL of aqueous solution contains: octreotide (as acetate) 200 mcgFOR SUBCUTANEOUS INJECTIONSTORAGE: Refrigerate at 2°C to 8°C (36°F to 46°F); protect from light.After initial use, d scard w thin 14 days.Mfd. by Novartis Pharma Stein AG

Rx onlyNDC 0078-0183-25

©Novartis

US

Sandostatinoctreotide acetateINJECTION1,000 mcg/5 mL (200 mcg/mL)Total Volume 5 mL Multi-Dose VialEach mL of aqueous solution contains: octreotide (as acetate) 200 mcgFOR SUBCUTANEOUS INJECTIONSTORAGE: Refrigerate at 2°C to 8°C (36°F to 46°F); protect from light.After initial use, d scard w thin 14 days.Mfd. by Novartis Pharma Stein AG

Rx onlyNDC 0078-0183-25

©Novartis

USSandostatinoctreotide acetateINJECTION1,000 mcg/5 mL (200 mcg/mL)Total Volume 5 mL Multi-Dose VialEach mL of aqueous solution contains: octreotide (as acetate) 200 mcgFOR SUBCUTANEOUS INJECTIONSTORAGE: Refrigerate at 2°C to 8°C (36°F to 46°F); protect from light.After initial use, d scard w thin 14 days.Mfd. by Novartis Pharma Stein AG

Rx onlyNDC 0078-0183-25

©Novartis

US12

5673

4B12

5673

4B12

5673

4B

EXP./

LOT

EXP./

LOT

EXP./

LOT

1256

734A

2567

34A

2567

34A

Page 5: INJECTION - Food and Drug Administration · INJECTION 5,000 mc g/ 5 mL (1,000 mcg/mL) FOR SUBCUTANEOUS INJECTION 5,000 mc g/ 5 mL ... Water for Injection, USP.....qs to …

1,000 mcg/5 mL (200 mcg/mL)

1,000 mcg/5 m

L (200 mcg/mL)

STORE REFRIGERATED AT 2°C to 8°C (36°F to 46°F); PROTECT FROM LIGHT.AFTER INITIAL USE, DISCARD WITHIN 14 DAYS

FOR SUBCUTANEOUS INJECTION

FOR SUBCUTANEOUS INJECTION

Total Volume 5 mL Multi-Dose Vial

Total Volume 5 m

L M

ulti-Dose Vial

Please open here Please open here

Sandostatin®

octreotide acetate INJECTIONEach mL of aqueous solution contains: octreotide (as acetate) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 200 mcgInactive ingredients:lactic acid, USP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.4 mgmannitol, USP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45 mgphenol, USP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.0 mgsodium bicarbonate, USP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .qs to pH 4.2 ± 0.3water for injection, USP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . qs to 1 mL DOSAGE: See package insert for dosage information.STORAGE: Refrigerate at 2°C to 8°C (36°F to 46°F); protect from light.After initial use, discard within 14 days. At room temperature, (20°C to 30°C or 70°F to 86°F), Sandostatin is stable for 14 days if protected from light.

Manufactured by: Novartis Pharma Stein AGSchaffhauserstrasse, CH-4332 Stein, SwitzerlandDistributed by:Novartis Pharmaceuticals CorporationEast Hanover, New Jersey 07936 ©Novartis

octreotide acetateINJECTION

octreotide acetateIN

JECTION

1,00

0 m

cg/5

mL

(200

mcg

/mL)

FOR

SUBC

UTAN

EOUS

INJE

CTIO

NTo

tal V

olum

e 5

mL

Mul

ti-Do

se V

ial

octr

eotid

e ac

etat

eIN

JECT

ION

Rx only

1256736

1256736

EXP.LOT

NDC 0078-0183-25

NDC

0078

-018

3-25

NDC 0078-0183-25

NDC 0078-0183-25

Page 6: INJECTION - Food and Drug Administration · INJECTION 5,000 mc g/ 5 mL (1,000 mcg/mL) FOR SUBCUTANEOUS INJECTION 5,000 mc g/ 5 mL ... Water for Injection, USP.....qs to …

Sandostatinoctreotide acetate Rx only

NDC 0078-0184-25

©Novartis

INJECTION5,000 mcg/5 mL (1,000 mcg/mL)Total Volume 5 mL Multi-Dose VialEach mL of aqueous solution contains: octreotide (as acetate) 1,000 mcgFOR SUBCUTANEOUS INJECTIONSTORAGE: Refrigerate at 2°C to 8°C (36°F to 46°F); protect from light.After initial use, discard with n 14 days.Mfd. by Novartis Pharma Stein AG

Sandostatinoctreotide acetate Rx only

NDC 0078-0184-25

©Novartis

INJECTION5,000 mcg/5 mL (1,000 mcg/mL)Total Volume 5 mL Multi-Dose VialEach mL of aqueous so ution contains: octreotide (as acetate) 1,000 mcgFOR SUBCUTANEOUS INJECTIONSTORAGE: Refrigerate at 2°C to 8°C (36°F to 46°F); protect from ight.After nitial use, discard within 14 days.Mfd. by Novartis Pharma Stein AG

Sandostatinoctreotide acetate Rx only

NDC 0078-0184-25

©Novartis

INJECTION5,000 mcg/5 mL (1,000 mcg/mL)Total Volume 5 mL Multi-Dose VialEach mL of aqueous so ution contains: octreotide (as acetate) 1,000 mcgFOR SUBCUTANEOUS INJECTIONSTORAGE: Refrigerate at 2°C to 8°C (36°F to 46°F); protect from ight.After nitial use, discard within 14 days.Mfd. by Novartis Pharma Stein AG

1256

740A

1256

740B

1256

740C

US

EXP./

LOT

EXP./

LOT

EXP./

LOT

2567

40A

1256

740B

1256

740C

US25

6740

A12

5674

0B12

5674

0CUS

Page 7: INJECTION - Food and Drug Administration · INJECTION 5,000 mc g/ 5 mL (1,000 mcg/mL) FOR SUBCUTANEOUS INJECTION 5,000 mc g/ 5 mL ... Water for Injection, USP.....qs to …

5,000 mcg/5 mL (1,000 mcg/mL)

STORE REFRIGERATED AT 2°C to 8°C (36°F to 46°F); PROTECT FROM LIGHT.AFTER INITIAL USE, DISCARD WITHIN 14 DAYS

FOR SUBCUTANEOUS INJECTIONTotal Volume 5 mL Multi-Dose Vial

Total Volume 5 m

L M

ulti-Dose Vial

Please open here Please open here

Sandostatin®

octreotide acetate INJECTIONEach mL of aqueous solution contains: octreotide (as acetate) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1,000 mcgInactive ingredients:lactic acid, USP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.4 mgmannitol, USP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45 mgphenol, USP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.0 mgsodium bicarbonate, USP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .qs to pH 4.2 ± 0.3water for injection, USP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . qs to 1 mL DOSAGE: See package insert for dosage information.STORAGE: Refrigerate at 2°C to 8°C (36°F to 46°F); protect from light.After initial use, discard within 14 days. At room temperature, (20°C to 30°C or 70°F to 86°F), Sandostatin is stable for 14 days if protected from light.

Manufactured by: Novartis Pharma Stein AGSchaffhauserstrasse, CH-4332 Stein, SwitzerlandDistributed by:Novartis Pharmaceuticals CorporationEast Hanover, New Jersey 07936 ©Novartis

octreotide acetateINJECTION

octreotide acetateIN

JECTION

5,00

0 m

cg/5

mL

(1,00

0 mcg

/mL)

FOR

SUBC

UTAN

EOUS

INJE

CTIO

N

5,000 mcg/5 m

L (1,000 mcg/mL)FOR SUBCUTANEOUS INJECTION

Tota

l Volu

me

5 m

L M

ulti-

Dose

Via

l

octr

eotid

e ac

etat

eIN

JECT

ION

Rx only

NDC 0078-0184-25

NDC 0078-0184-25ND

C 00

78-0

184-

25

NDC 0078-0184-25

1256743

1256743

1256743

EXP.LOT

Page 8: INJECTION - Food and Drug Administration · INJECTION 5,000 mc g/ 5 mL (1,000 mcg/mL) FOR SUBCUTANEOUS INJECTION 5,000 mc g/ 5 mL ... Water for Injection, USP.....qs to …

XXXX

For Subcutaneous Injection10 x 1 mL Single-Dose Vials

NDC 0781-3166-95

OCTREOTIDE Acetate Injection50 mcg/mL

NDC 0781-3166-95

OCTREOTIDE Acetate Injection50 mcg/mL

For Subcutaneous Injection10 x 1 mL Single-Dose Vials

Each mL of aqueous solution contains:Octreotide (as acetate)...................50 mcg

Inactive ingredients:Lactic Acid, USP.............................3.4 mgMannitol, USP..................................45 mgSodium Bicarbonate,USP...........................qs to pH 4.2 ± 0.3

Water for Injection, USP.............qs to 1 mL

Dosage: See package insert for dosageinformation.

Store refrigerated between 2ºCto 8ºC(36ºFto 46ºF). Protect from light.At room temperature, (20ºC to 30ºC or70ºF to 86ºF), Octreotide Acetate is stablefor 14 days if protected fromlight.KEEP THIS AND ALL DRUGS OUT OFTHE REACH OF CHILDREN.

01-2015MManufactured in Canada bySandoz Canada Inc. forSandoz Inc., Princeton, NJ 08540

NDC0781-3166-95

OCTR

EOTID

EA

cetate Injectio

n5

0 m

cg/m

L

XXXXXXX

10 x 1 mL Single-D

ose V

ials

Page 9: INJECTION - Food and Drug Administration · INJECTION 5,000 mc g/ 5 mL (1,000 mcg/mL) FOR SUBCUTANEOUS INJECTION 5,000 mc g/ 5 mL ... Water for Injection, USP.....qs to …

XXXX

For Subcutaneous Injection10 x 1 mL Single-Dose Vials

NDC 0781-3167-95

OCTREOTIDE Acetate Injection100 mcg/mL

NDC 0781-3167-95

OCTREOTIDE Acetate Injection100 mcg/mL

For Subcutaneous Injection10 x 1 mL Single-Dose Vials

Each mL of aqueous solution contains:Octreotide (as acetate).................100 mcg

Inactive ingredients:Lactic Acid, USP.............................3.4 mgMannitol, USP..................................45 mgSodium Bicarbonate, USP............................qs to pH 4.2 ± 0.3Water for Injection, USP.............qs to 1 mL

Dosage: See package insert for dosage information.

Store refrigerated between 2ºCto 8ºC (36ºFto 46ºF). Protect from light.At room temperature, (20ºC to 30ºC or70ºF to 86ºF), Octreotide Acetate is stablefor 14 days if protected from light.KEEP THIS AND ALL DRUGS OUT OF THEREACH OF CHILDREN.

01-2015MManufactured in Canada bySandoz Canada Inc. forSandoz Inc., Princeton, NJ 08540

NDC0781-3167-95

OCTR

EOTID

EA

cetate Injectio

n10

0 m

cg/m

L

XXXXXXX

10 x 1 mL Single-D

ose V

ials

Page 10: INJECTION - Food and Drug Administration · INJECTION 5,000 mc g/ 5 mL (1,000 mcg/mL) FOR SUBCUTANEOUS INJECTION 5,000 mc g/ 5 mL ... Water for Injection, USP.....qs to …

XXXX

XXXXXXX

For Subcutaneous Injection10 x 1 mL Single-Dose Vials

NDC 0781-3168-95

OCTREOTIDE Acetate Injection500 mcg/mL

NDC 0781-3168-95

OCTREOTIDE Acetate Injection500 mcg/mL

For Subcutaneous Injection10 x 1 mL Single-Dose Vials

Each mL of aqueous solution contains:Octreotide (as acetate).................500 mcg

Inactive ingredients:Lactic Acid, USP.............................3.4 mgMannitol, USP..................................45 mgSodium Bicarbonate, USP............................qs to pH 4.2 ± 0.3Water for Injection, USP.............qs to 1 mL

Dosage: See package insert for dosage information.

Store refrigerated between 2ºCto 8ºC (36ºFto 46ºF). Protect from light.At room temperature, (20ºC to 30ºC or70ºF to 86ºF), Octreotide Acetate is stablefor 14 days if protected from light.KEEP THIS AND ALL DRUGS OUT OF THEREACH OF CHILDREN.

01-2015MManufactured in Canada bySandoz Canada Inc. forSandoz Inc., Princeton, NJ 08540

10 x 1 mL Single-D

ose V

ials

NDC0781-3168-95

OCTR

EOTID

EA

cetate Injectio

n5

00

mcg

/mL

Page 11: INJECTION - Food and Drug Administration · INJECTION 5,000 mc g/ 5 mL (1,000 mcg/mL) FOR SUBCUTANEOUS INJECTION 5,000 mc g/ 5 mL ... Water for Injection, USP.....qs to …

Lot:

Exp.:

RSS 10307813165757

NDC 0781-3165-75

OCTREOTIDEAcetate Injection

For Subcutaneous Injection

1,000 mcg/5 mL(200 mcg/mL)

Each mL of aqueous solutioncontains: Octreotide (asacetate) 200 mcgStorage: Refrigerate at 2°Cto 8°C (36°F to 46°F); protectfrom light. After initial use,discard within 14 days.01-2015MManufactured in Canada bySandoz Canada Inc. forSandoz Inc.Princeton, NJ 08540

XXXXX

Total Volume 5 mL Multi-Dose Vial

Page 12: INJECTION - Food and Drug Administration · INJECTION 5,000 mc g/ 5 mL (1,000 mcg/mL) FOR SUBCUTANEOUS INJECTION 5,000 mc g/ 5 mL ... Water for Injection, USP.....qs to …

XXXXXXX

Storage: Refrigerate at2ºC to 8ºC (36ºF to 46ºF);protect from light. Afterinitial use, discard within14 days.

At room temperature,(20ºC to 30ºC or 70ºF to86ºF), Octreotide Acetateis stable for 14 days ifprotected from light.

KEEP THIS AND ALLDRUGS OUT OF THEREACH OF CHILDREN.

Each mL of aqueoussolution contains:Octreotide(as acetate) .........200 mcg

Inactive Ingredients:Lactic Acid, USP ....... 3.4 mgMannitol, USP............ 45 mgPhenol, USP ..............5.0 mgSodium Bicarbonate,USP ......qs to pH 4.2 ± 0.3

Water for Injection,USP ..................qs to 1 mL

DOSAGE: See packageinsert for dosageinformation.

Manufactured in Canada bySandoz Canada Inc. forSandoz Inc.Princeton, NJ 08540

01-2015M

NDC 0781-3165-75

OCTREOTIDEAcetateInjection

ForSubcutaneousInjection

1,000 mcg/5 mL(200 mcg/mL)

NDC 0781-3165-75

OCTREOTIDEAcetate Injection1,000 mcg/5 mL

(200 mcg/mL)

Total Volume 5 mL Multi-

Dose Vial

ForSubcutaneousInjection

Total Volume 5 mLMulti-Dose Vial

(b) (4)

(b) (4)

Page 13: INJECTION - Food and Drug Administration · INJECTION 5,000 mc g/ 5 mL (1,000 mcg/mL) FOR SUBCUTANEOUS INJECTION 5,000 mc g/ 5 mL ... Water for Injection, USP.....qs to …

Lot:

Exp.:

RSS 10307813164750

NDC 0781-3164-75

OCTREOTIDEAcetate Injection

For Subcutaneous Injection

5,000 mcg/5mL(1,000 mcg/mL)

Each mL of aqueous solutioncontains: Octreotide (asacetate) 1,000 mcgStorage: Refrigerate at 2°Cto 8°C (36°F to 46°F); protectfrom light. After initial use,discard within 14 days.01-2015MManufactured in Canada bySandoz Canada Inc. forSandoz Inc.Princeton, NJ 08540

XXXXX

Total Volume 5 mL Multi-Dose Vial

Page 14: INJECTION - Food and Drug Administration · INJECTION 5,000 mc g/ 5 mL (1,000 mcg/mL) FOR SUBCUTANEOUS INJECTION 5,000 mc g/ 5 mL ... Water for Injection, USP.....qs to …

XXXXXXX

Storage: Refrigerate at2ºC to 8ºC (36ºF to 46ºF);protect from light. Afterinitial use, discard within14 days.

At room temperature,(20ºC to 30ºC or 70ºF to86ºF), Octreotide Acetateis stable for 14 days ifprotected from light.

KEEP THIS AND ALLDRUGS OUT OF THEREACH OF CHILDREN.

Each mL of aqueoussolution contains:Octreotide(as acetate) ......1,000 mcg

Inactive Ingredients:Lactic Acid, USP ....... 3.4 mgMannitol, USP............ 45 mgPhenol, USP ..............5.0 mgSodium Bicarbonate,USP ......qs to pH 4.2 ± 0.3

Water for Injection,USP ..................qs to 1 mL

DOSAGE: See packageinsert for dosageinformation.

Manufactured in Canada bySandoz Canada Inc. forSandoz Inc.Princeton, NJ 08540

01-2015M

NDC 0781-3164-75

OCTREOTIDEAcetate Injection5,000 mcg/5 mL(1,000 mcg/mL)

Total Volume 5 mL Multi-

Dose Vial

ForSubcutaneousInjection

NDC 0781-3164-75

OCTREOTIDEAcetateInjection

ForSubcutaneousInjection

5,000 mcg/5 mL(1,000 mcg/mL)

Total Volume 5 mLMulti-Dose Vial

(b) (4)

(b) (4)