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 use Initial U.S. Approval: 1988
Approved
Approval ID
2344ae7a-c2f0-433b-9133-1dcb16bb18a0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 21, 2023
Manufacturers
FDA
Gland Pharma Limited
DUNS: 918601238
Products 2
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 Code68083-516
Application NumberANDA216807
Product Classification
M
Marketing Category
C73584
G
Generic Name
Octreotide Acetate
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRAVENOUS
Effective DateDecember 20, 2023
FDA Product Classification
INGREDIENTS (6)
OCTREOTIDE ACETATEActive
Quantity: 1000 ug in 1 mL
Code: 75R0U2568I
Classification: ACTIM
LACTIC ACID, UNSPECIFIED FORMInactive
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
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 Code68083-515
Application NumberANDA216807
Product Classification
M
Marketing Category
C73584
G
Generic Name
Octreotide Acetate
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRAVENOUS
Effective DateDecember 20, 2023
FDA Product Classification
INGREDIENTS (6)
OCTREOTIDE ACETATEActive
Quantity: 200 ug in 1 mL
Code: 75R0U2568I
Classification: ACTIM
PHENOLInactive
Quantity: 5 mg in 1 mL
Code: 339NCG44TV
Classification: IACT
MANNITOLInactive
Quantity: 45 mg in 1 mL
Code: 3OWL53L36A
Classification: IACT
LACTIC ACID, UNSPECIFIED FORMInactive
Quantity: 3.4 mg in 1 mL
Code: 33X04XA5AT
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT