Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
HIKMA FARMACEUTICA (PORTUGAL), S.A
Hikma Pharmaceuticals USA Inc.
452742943
Products2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Granisetron Hydrochloride
Product Details
NDC Product Code
0143-9744Application Number
ANDA078629Marketing Category
ANDA (C73584)Route of Administration
INTRAVENOUSEffective Date
January 4, 2024SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 9 mg in 1 mL
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSLClass: IACTQuantity: 2 mg in 1 mL
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
GranisetronActive
Code: 318F6L70J8Class: ACTIMQuantity: 1 mg in 1 mL
BENZYL ALCOHOLInactive
Code: LKG8494WBHClass: IACTQuantity: 10 mg in 1 mL
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
Granisetron Hydrochloride
Product Details
NDC Product Code
0143-9745Application Number
ANDA078629Marketing Category
ANDA (C73584)Route of Administration
INTRAVENOUSEffective Date
January 4, 2024GranisetronActive
Code: 318F6L70J8Class: ACTIMQuantity: 1 mg in 1 mL
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBHClass: IACTQuantity: 10 mg in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 9 mg in 1 mL
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSLClass: IACTQuantity: 2 mg in 1 mL