OCTREOTIDE ACETATE (Page 5 of 5)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL — 1,000 mcg*/5 mL

Vial Label
NDC 23155-685 -31
Rx only
Octreotide Acetate Injection
1,000 mcg*/5 mL
(200 mcg*/ mL)
For Subcutaneous or Intravenous Use *Each mL contains octreotide acetate, USP equivalent to 200 mcg octreotide.

1000mcg-5ml-vial-label
(click image for full-size original)

Carton
NDC 23155-685 -31
Rx only
Octreotide Acetate Injection
1,000 mcg*/5 mL
(200 mcg*/ mL)
For Subcutaneous or Intravenous Use *Each mL contains octreotide acetate, USP equivalent to 200 mcg octreotide.

1000mcg-5ml-carton
(click image for full-size original)

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.

5000mcg-5ml-vial-label
(click image for full-size original)

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.

5000mcg-5ml-carton
(click image for full-size original)

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.

50mcg-1ml-vial-label
(click image for full-size original)

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.

50mcg-1ml-carton
(click image for full-size original)

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.

100mcg-1ml-vial-label
(click image for full-size original)

Carton Label NDC 23155-688- 41
Rx only
Octreotide Acetate Injection
100 mcg*/mLFor Subcutaneous or Intravenous Use
*Each mL contains octreotide acetate, USP equivalent to 100 mcg octreotide.

100mcg-1ml-carton.
(click image for full-size original)

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.

500mcg-1ml-vial-label
(click image for full-size original)

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.

500mcg-1ml-carton
(click image for full-size original)
OCTREOTIDE ACETATE octreotide acetate injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:23155-685
Route of Administration INTRAVENOUS, INTRAVENOUS 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: 01/2024 Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.

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