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OCTREOTIDE ACETATE

These highlights do not include all the information needed to use OCTREOTIDE ACETATE INJECTION safely and effectively. See full prescribing information for OCTREOTIDE ACETATE INJECTION. OCTREOTIDE ACETATE INJECTION, for subcutaneous or intravenous useInitial U.S. Approval: 1988

Approved
Approval ID

ffaf9462-cdd8-433b-8b03-464a35577fe9

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 10, 2024

Manufacturers
FDA

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

DUNS: 780779901

Products 5

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

octreotide acetate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code23155-689
Application NumberANDA204669
Product Classification
M
Marketing Category
C73584
G
Generic Name
octreotide acetate
Product Specifications
Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
Effective DateJanuary 10, 2024
FDA Product Classification

INGREDIENTS (5)

OCTREOTIDE ACETATEActive
Quantity: 500 ug in 1 mL
Code: 75R0U2568I
Classification: ACTIM
ACETIC ACIDInactive
Quantity: 2 mg in 1 mL
Code: Q40Q9N063P
Classification: IACT
SODIUM ACETATEInactive
Quantity: 2 mg in 1 mL
Code: 4550K0SC9B
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 7 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

octreotide acetate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code23155-687
Application NumberANDA204669
Product Classification
M
Marketing Category
C73584
G
Generic Name
octreotide acetate
Product Specifications
Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
Effective DateJanuary 10, 2024
FDA Product Classification

INGREDIENTS (5)

ACETIC ACIDInactive
Quantity: 2 mg in 1 mL
Code: Q40Q9N063P
Classification: IACT
OCTREOTIDE ACETATEActive
Quantity: 50 ug in 1 mL
Code: 75R0U2568I
Classification: ACTIM
SODIUM ACETATEInactive
Quantity: 2 mg in 1 mL
Code: 4550K0SC9B
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 7 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT

octreotide acetate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code23155-688
Application NumberANDA204669
Product Classification
M
Marketing Category
C73584
G
Generic Name
octreotide acetate
Product Specifications
Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
Effective DateJanuary 10, 2024
FDA Product Classification

INGREDIENTS (5)

OCTREOTIDE ACETATEActive
Quantity: 100 ug in 1 mL
Code: 75R0U2568I
Classification: ACTIM
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 7 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
SODIUM ACETATEInactive
Quantity: 2 mg in 1 mL
Code: 4550K0SC9B
Classification: IACT
ACETIC ACIDInactive
Quantity: 2 mg in 1 mL
Code: Q40Q9N063P
Classification: IACT

octreotide acetate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code23155-686
Application NumberANDA203765
Product Classification
M
Marketing Category
C73584
G
Generic Name
octreotide acetate
Product Specifications
Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
Effective DateJanuary 10, 2024
FDA Product Classification

INGREDIENTS (6)

OCTREOTIDE ACETATEActive
Quantity: 1000 ug in 1 mL
Code: 75R0U2568I
Classification: ACTIM
ACETIC ACIDInactive
Quantity: 2 mg in 1 mL
Code: Q40Q9N063P
Classification: IACT
SODIUM ACETATEInactive
Quantity: 2 mg in 1 mL
Code: 4550K0SC9B
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 7 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
PHENOLInactive
Quantity: 5 mg in 1 mL
Code: 339NCG44TV
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

octreotide acetate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code23155-685
Application NumberANDA203765
Product Classification
M
Marketing Category
C73584
G
Generic Name
octreotide acetate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJanuary 10, 2024
FDA Product Classification

INGREDIENTS (6)

OCTREOTIDE ACETATEActive
Quantity: 200 ug in 1 mL
Code: 75R0U2568I
Classification: ACTIM
ACETIC ACIDInactive
Quantity: 2 mg in 1 mL
Code: Q40Q9N063P
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 7 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
PHENOLInactive
Quantity: 5 mg in 1 mL
Code: 339NCG44TV
Classification: IACT
SODIUM ACETATEInactive
Quantity: 2 mg in 1 mL
Code: 4550K0SC9B
Classification: IACT

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OCTREOTIDE ACETATE - FDA Drug Approval Details