OCTREOTIDE ACETATE: Package Insert and Label Information (Page 3 of 3)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL — 5,000 mcg*/5 mL

Vial Label

NDC 23155-686 -31

Rx only

Octreotide Acetate Injection

5,000 mcg*/5 mL

(1,000 mcg*/ mL)

For Subcutaneous or Intravenous Use

*Each mL contains octreotide acetate, USP equivalent to 1,000 mcg octreotide.

Carton

NDC 23155-686 -31

Rx only

Octreotide Acetate Injection

5,000 mcg*/5 mL

(1,000 mcg*/ mL)

For Subcutaneous or Intravenous Use

*Each mL contains octreotide acetate, USP equivalent to 1,000 mcg octreotide.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL — 50 mcg*/mL

Vial Label

NDC 23155-687 -31

Rx only

Octreotide Acetate Injection

50mcg*/mL

For Subcutaneous or Intravenous Use

*Each mL contains octreotide acetate, USP equivalent to 50 mcg octreotide.

Carton Label

NDC 23155-687 -41

Rx only

Octreotide Acetate Injection

50mcg*/mL

For Subcutaneous or Intravenous Use

*Each mL contains octreotide acetate, USP equivalent to 50 mcg octreotide.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL — 100 mcg*/mL

Vial Label

NDC 23155-688 -31

Rx only

Octreotide Acetate Injection

100 mcg*/mL

For Subcutaneous or Intravenous Use

*Each mL contains octreotide acetate, USP equivalent to 100 mcg octreotide.

Carton Label

NDC 23155-688 -41

Rx only

Octreotide Acetate Injection

100 mcg*/mL

For Subcutaneous or Intravenous Use

*Each mL contains octreotide acetate, USP equivalent to 100 mcg octreotide.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL — 500 mcg*/mL

Vial Label

NDC 23155-689 -31

Rx only

Octreotide Acetate Injection

500 mcg*/mL

For Subcutaneous or Intravenous Use

*Each mL contains octreotide acetate, USP equivalent to 500 mcg octreotide.

Carton Label

NDC 23155-689 -41

Rx only

Octreotide Acetate Injection

500 mcg*/mL

For Subcutaneous or Intravenous Use

*Each mL contains octreotide acetate, USP equivalent to 500 mcg octreotide.

OCTREOTIDE ACETATE octreotide acetate injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:23155-685 Route of Administration INTRAVENOUS, SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTREOTIDE ACETATE (OCTREOTIDE) OCTREOTIDE 200 ug in 1 mL

Inactive Ingredients Ingredient Name Strength ACETIC ACID 2 mg in 1 mL SODIUM ACETATE 2 mg in 1 mL SODIUM CHLORIDE 7 mg in 1 mL PHENOL 5 mg in 1 mL WATER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:23155-685-31 5 mL in 1 VIAL, GLASS None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA203765 05/25/2022

OCTREOTIDE ACETATE octreotide acetate injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:23155-686 Route of Administration INTRAVENOUS, SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTREOTIDE ACETATE (OCTREOTIDE) OCTREOTIDE 1000 ug in 1 mL

Inactive Ingredients Ingredient Name Strength ACETIC ACID 2 mg in 1 mL SODIUM ACETATE 2 mg in 1 mL SODIUM CHLORIDE 7 mg in 1 mL PHENOL 5 mg in 1 mL WATER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:23155-686-31 5 mL in 1 VIAL, GLASS None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA203765 05/25/2022

OCTREOTIDE ACETATE octreotide acetate injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:23155-687 Route of Administration INTRAVENOUS, SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTREOTIDE ACETATE (OCTREOTIDE) OCTREOTIDE 50 ug in 1 mL

Inactive Ingredients Ingredient Name Strength ACETIC ACID 2 mg in 1 mL SODIUM ACETATE 2 mg in 1 mL SODIUM CHLORIDE 7 mg in 1 mL WATER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:23155-687-41 10 VIAL, GLASS in 1 CARTON contains a VIAL, GLASS (23155-687-31) 1 NDC:23155-687-31 1 mL in 1 VIAL, GLASS This package is contained within the CARTON (23155-687-41)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA204669 05/25/2022

OCTREOTIDE ACETATE octreotide acetate injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:23155-688 Route of Administration INTRAVENOUS, SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTREOTIDE ACETATE (OCTREOTIDE) OCTREOTIDE 100 ug in 1 mL

Inactive Ingredients Ingredient Name Strength ACETIC ACID 2 mg in 1 mL SODIUM ACETATE 2 mg in 1 mL SODIUM CHLORIDE 7 mg in 1 mL WATER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:23155-688-41 10 VIAL, GLASS in 1 CARTON contains a VIAL, GLASS (23155-688-31) 1 NDC:23155-688-31 1 mL in 1 VIAL, GLASS This package is contained within the CARTON (23155-688-41)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA204669 05/25/2022

OCTREOTIDE ACETATE octreotide acetate injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:23155-689 Route of Administration INTRAVENOUS, SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTREOTIDE ACETATE (OCTREOTIDE) OCTREOTIDE 500 ug in 1 mL

Inactive Ingredients Ingredient Name Strength ACETIC ACID 2 mg in 1 mL SODIUM ACETATE 2 mg in 1 mL SODIUM CHLORIDE 7 mg in 1 mL WATER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:23155-689-41 10 VIAL, GLASS in 1 CARTON contains a VIAL, GLASS (23155-689-31) 1 NDC:23155-689-31 1 mL in 1 VIAL, GLASS This package is contained within the CARTON (23155-689-41)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA204669 05/25/2022

Labeler — Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. (780779901)

Registrant — Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. (780779901)

Establishment
Name	Address	ID/FEI	Operations
USV Private Limited		650434348	PACK (23155-685), PACK (23155-686), pack (23155-687), pack (23155-688), pack (23155-689), MANUFACTURE (23155-685), MANUFACTURE (23155-686), manufacture (23155-687), manufacture (23155-688), manufacture (23155-689)

Revised: 11/2022 Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.