Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Gland Pharma Limited
Gland Pharma Limited
858971074
Products2
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
68083-517Application Number
ANDA216839Marketing Category
ANDA (C73584)Route of Administration
INTRAVENOUS, SUBCUTANEOUSEffective Date
November 22, 2023OctreotideActive
Code: 75R0U2568IClass: ACTIMQuantity: 100 ug in 1 mL
LACTIC ACID, UNSPECIFIED FORMInactive
Code: 33X04XA5ATClass: IACTQuantity: 3.4 mg in 1 mL
MANNITOLInactive
Code: 3OWL53L36AClass: IACTQuantity: 45 mg in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACT
Octreotide Acetate
Product Details
NDC Product Code
68083-560Application Number
ANDA216839Marketing Category
ANDA (C73584)Route of Administration
INTRAVENOUS, SUBCUTANEOUSEffective Date
November 22, 2023LACTIC ACID, UNSPECIFIED FORMInactive
Code: 33X04XA5ATClass: IACTQuantity: 3.4 mg in 1 mL
OctreotideActive
Code: 75R0U2568IClass: ACTIMQuantity: 500 ug in 1 mL
MANNITOLInactive
Code: 3OWL53L36AClass: IACTQuantity: 45 mg in 1 mL
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT