Clinical Trials

Find trials by condition, location & phase

Drug Monographs

Browse drug monographs and information

Explore organizations and their profiles

Latest updates on trials and healthcare

Approved products by global authorities

AI-Powered Research

Discover powerful insights with advanced AI analysis tools for clinical trials.

Premium Access

Get unlimited access to our comprehensive pharmaceutical database and analytics.

FDA Approval

OCTREOTIDE ACETATE

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company

Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.

DUNS: 780779901

Effective Date

January 10, 2024

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Octreotide(500 ug in 1 mL)

Registrants1

Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.

Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.

DUNS Number

780779901

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

USV Private Limited

Labeler

Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.

Registrant

Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.

DUNS Number

650434348

Products5

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

OCTREOTIDE ACETATE

Product Details

NDC Product Code

23155-689

Application Number

ANDA204669

Marketing Category

ANDA (C73584)

Route of Administration

INTRAVENOUS, SUBCUTANEOUS

Effective Date

January 10, 2024

Ingredients

OctreotideActive

Code: 75R0U2568IClass: ACTIMQuantity: 500 ug in 1 mL

ACETIC ACIDInactive

Code: Q40Q9N063PClass: IACTQuantity: 2 mg in 1 mL

SODIUM ACETATEInactive

Code: 4550K0SC9BClass: IACTQuantity: 2 mg in 1 mL

SODIUM CHLORIDEInactive

Code: 451W47IQ8XClass: IACTQuantity: 7 mg in 1 mL

WATERInactive

Code: 059QF0KO0RClass: IACT

OCTREOTIDE ACETATE

Product Details

NDC Product Code

23155-687

Application Number

ANDA204669

Marketing Category

ANDA (C73584)

Route of Administration

INTRAVENOUS, SUBCUTANEOUS

Effective Date

January 10, 2024

Ingredients

ACETIC ACIDInactive

Code: Q40Q9N063PClass: IACTQuantity: 2 mg in 1 mL

OctreotideActive

Code: 75R0U2568IClass: ACTIMQuantity: 50 ug in 1 mL

SODIUM ACETATEInactive

Code: 4550K0SC9BClass: IACTQuantity: 2 mg in 1 mL

WATERInactive

Code: 059QF0KO0RClass: IACT

SODIUM CHLORIDEInactive

Code: 451W47IQ8XClass: IACTQuantity: 7 mg in 1 mL

OCTREOTIDE ACETATE

Product Details

NDC Product Code

23155-688

Application Number

ANDA204669

Marketing Category

ANDA (C73584)

Route of Administration

INTRAVENOUS, SUBCUTANEOUS

Effective Date

January 10, 2024

Ingredients

OctreotideActive

Code: 75R0U2568IClass: ACTIMQuantity: 100 ug in 1 mL

WATERInactive

Code: 059QF0KO0RClass: IACT

SODIUM CHLORIDEInactive

Code: 451W47IQ8XClass: IACTQuantity: 7 mg in 1 mL

SODIUM ACETATEInactive

Code: 4550K0SC9BClass: IACTQuantity: 2 mg in 1 mL

ACETIC ACIDInactive

Code: Q40Q9N063PClass: IACTQuantity: 2 mg in 1 mL

OCTREOTIDE ACETATE

Product Details

NDC Product Code

23155-686

Application Number

ANDA203765

Marketing Category

ANDA (C73584)

Route of Administration

INTRAVENOUS, SUBCUTANEOUS

Effective Date

January 10, 2024

Ingredients

OctreotideActive

Code: 75R0U2568IClass: ACTIMQuantity: 1000 ug in 1 mL

ACETIC ACIDInactive

Code: Q40Q9N063PClass: IACTQuantity: 2 mg in 1 mL

SODIUM ACETATEInactive

Code: 4550K0SC9BClass: IACTQuantity: 2 mg in 1 mL

SODIUM CHLORIDEInactive

Code: 451W47IQ8XClass: IACTQuantity: 7 mg in 1 mL

PHENOLInactive

Code: 339NCG44TVClass: IACTQuantity: 5 mg in 1 mL

WATERInactive

Code: 059QF0KO0RClass: IACT

OCTREOTIDE ACETATE

Product Details

NDC Product Code

23155-685

Application Number

ANDA203765

Marketing Category

ANDA (C73584)

Route of Administration

INTRAVENOUS

Effective Date

January 10, 2024

Ingredients

OctreotideActive

Code: 75R0U2568IClass: ACTIMQuantity: 200 ug in 1 mL

ACETIC ACIDInactive

Code: Q40Q9N063PClass: IACTQuantity: 2 mg in 1 mL

WATERInactive

Code: 059QF0KO0RClass: IACT

SODIUM CHLORIDEInactive

Code: 451W47IQ8XClass: IACTQuantity: 7 mg in 1 mL

PHENOLInactive

Code: 339NCG44TVClass: IACTQuantity: 5 mg in 1 mL

SODIUM ACETATEInactive

Code: 4550K0SC9BClass: IACTQuantity: 2 mg in 1 mL

© Copyright 2025. All Rights Reserved by MedPath

Home Terms & Conditions Privacy Policy