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
68083-516Application Number
ANDA216807Marketing Category
ANDA (C73584)Route of Administration
SUBCUTANEOUS, INTRAVENOUSEffective Date
December 20, 2023OctreotideActive
Code: 75R0U2568IClass: ACTIMQuantity: 1000 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
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACT
PHENOLInactive
Code: 339NCG44TVClass: IACTQuantity: 5 mg in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
Octreotide Acetate
Product Details
NDC Product Code
68083-515Application Number
ANDA216807Marketing Category
ANDA (C73584)Route of Administration
SUBCUTANEOUS, INTRAVENOUSEffective Date
December 20, 2023OctreotideActive
Code: 75R0U2568IClass: ACTIMQuantity: 200 ug in 1 mL
PHENOLInactive
Code: 339NCG44TVClass: IACTQuantity: 5 mg in 1 mL
MANNITOLInactive
Code: 3OWL53L36AClass: IACTQuantity: 45 mg in 1 mL
LACTIC ACID, UNSPECIFIED FORMInactive
Code: 33X04XA5ATClass: IACTQuantity: 3.4 mg in 1 mL
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT