Octreotide Acetate
Octreotide Acetate Injection Rx Only Prescribing Information
Approved
Approval ID
387d7f8d-9762-4f6b-99e1-bdc50b8a1633
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 29, 2023
Manufacturers
FDA
GLENMARK PHARMACEUTICALS INC., USA
DUNS: 130597813
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 Code68462-896
Application NumberANDA216839
Product Classification
M
Marketing Category
C73584
G
Generic Name
Octreotide Acetate
Product Specifications
Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
Effective DateNovember 29, 2023
FDA Product Classification
INGREDIENTS (5)
OCTREOTIDE ACETATEActive
Quantity: 100 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
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Octreotide Acetate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68462-897
Application NumberANDA216839
Product Classification
M
Marketing Category
C73584
G
Generic Name
Octreotide Acetate
Product Specifications
Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
Effective DateNovember 29, 2023
FDA Product Classification
INGREDIENTS (5)
OCTREOTIDE ACETATEActive
Quantity: 500 ug in 1 mL
Code: 75R0U2568I
Classification: ACTIM
WATERInactive
Code: 059QF0KO0R
Classification: IACT
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