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FDA Approval

Octreotide Acetate

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

FDA Approval Summary

Company

Hikma Pharmaceuticals USA Inc.

DUNS: 946499746

Effective Date

July 27, 2021

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Octreotide(50 ug in 1 mL)

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

0641-6174

Application Number

ANDA076313

Marketing Category

ANDA (C73584)

Route of Administration

INTRAVENOUS, SUBCUTANEOUS

Effective Date

July 27, 2021

Ingredients

SODIUM HYDROXIDEInactive

Code: 55X04QC32IClass: IACT

OctreotideActive

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

LACTIC ACID, L-Inactive

Code: F9S9FFU82NClass: IACTQuantity: 3 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

0641-6177

Application Number

ANDA076330

Marketing Category

ANDA (C73584)

Route of Administration

INTRAVENOUS, SUBCUTANEOUS

Effective Date

July 27, 2021

Ingredients

OctreotideActive

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

LACTIC ACID, L-Inactive

Code: F9S9FFU82NClass: IACTQuantity: 3 mg in 1 mL

SODIUM CHLORIDEInactive

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

SODIUM HYDROXIDEInactive

Code: 55X04QC32IClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

PHENOLInactive

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

Octreotide Acetate

Product Details

NDC Product Code

0641-6178

Application Number

ANDA076330

Marketing Category

ANDA (C73584)

Route of Administration

INTRAVENOUS, SUBCUTANEOUS

Effective Date

July 27, 2021

Ingredients

LACTIC ACID, L-Inactive

Code: F9S9FFU82NClass: IACTQuantity: 3 mg in 1 mL

OctreotideActive

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

SODIUM CHLORIDEInactive

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

SODIUM HYDROXIDEInactive

Code: 55X04QC32IClass: IACT

PHENOLInactive

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

WATERInactive

Code: 059QF0KO0RClass: IACT

Octreotide Acetate

Product Details

NDC Product Code

0641-6175

Application Number

ANDA076313

Marketing Category

ANDA (C73584)

Route of Administration

INTRAVENOUS, SUBCUTANEOUS

Effective Date

July 27, 2021

Ingredients

SODIUM CHLORIDEInactive

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

LACTIC ACID, L-Inactive

Code: F9S9FFU82NClass: IACTQuantity: 3 mg in 1 mL

OctreotideActive

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

SODIUM HYDROXIDEInactive

Code: 55X04QC32IClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

Octreotide Acetate

Product Details

NDC Product Code

0641-6176

Application Number

ANDA076313

Marketing Category

ANDA (C73584)

Route of Administration

INTRAVENOUS, SUBCUTANEOUS

Effective Date

July 27, 2021

Ingredients

LACTIC ACID, L-Inactive

Code: F9S9FFU82NClass: IACTQuantity: 3 mg in 1 mL

SODIUM HYDROXIDEInactive

Code: 55X04QC32IClass: IACT

OctreotideActive

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

SODIUM CHLORIDEInactive

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

WATERInactive

Code: 059QF0KO0RClass: IACT

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