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Sandostatin

These highlights do not include all the information needed to use SANDOSTATIN INJECTION safely and effectively. See full prescribing information for SANDOSTATIN INJECTION. SANDOSTATIN (octreotide acetate) INJECTION, for subcutaneous or intravenous use Initial U.S. Approval: 1988

Approved
Approval ID

4e2c9856-1836-49f0-9472-4dbeeb408f39

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 3, 2023

Manufacturers
FDA

Novartis Pharmaceuticals Corporation

DUNS: 002147023

Products 3

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 Code0078-0182
Application NumberNDA019667
Product Classification
M
Marketing Category
C73594
G
Generic Name
octreotide acetate
Product Specifications
Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
Effective DateNovember 3, 2023
FDA Product Classification

INGREDIENTS (5)

LACTIC ACIDInactive
Quantity: 3.4 mg in 1 mL
Code: 33X04XA5AT
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
OCTREOTIDE ACETATEActive
Quantity: 500 ug in 1 mL
Code: 75R0U2568I
Classification: ACTIM
MANNITOLInactive
Quantity: 45 mg in 1 mL
Code: 3OWL53L36A
Classification: IACT

octreotide acetate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0078-0181
Application NumberNDA019667
Product Classification
M
Marketing Category
C73594
G
Generic Name
octreotide acetate
Product Specifications
Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
Effective DateNovember 3, 2023
FDA Product Classification

INGREDIENTS (5)

OCTREOTIDE ACETATEActive
Quantity: 100 ug in 1 mL
Code: 75R0U2568I
Classification: ACTIM
MANNITOLInactive
Quantity: 45 mg in 1 mL
Code: 3OWL53L36A
Classification: IACT
LACTIC ACIDInactive
Quantity: 3.4 mg in 1 mL
Code: 33X04XA5AT
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT

octreotide acetate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0078-0180
Application NumberNDA019667
Product Classification
M
Marketing Category
C73594
G
Generic Name
octreotide acetate
Product Specifications
Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
Effective DateNovember 3, 2023
FDA Product Classification

INGREDIENTS (5)

OCTREOTIDE ACETATEActive
Quantity: 50 ug in 1 mL
Code: 75R0U2568I
Classification: ACTIM
LACTIC ACIDInactive
Quantity: 3.4 mg in 1 mL
Code: 33X04XA5AT
Classification: IACT
MANNITOLInactive
Quantity: 45 mg in 1 mL
Code: 3OWL53L36A
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

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Sandostatin - FDA Drug Approval Details