Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
West-Ward Columbus Inc.
Hikma Pharmaceuticals USA Inc.
058839929
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ondansetron Hydrochloride
Product Details
NDC Product Code
0054-0064Application Number
ANDA076960Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
October 4, 2016OndansetronActive
Code: NMH84OZK2BClass: ACTIMQuantity: 4 mg in 5 mL
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSLClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
SACCHARIN SODIUM ANHYDROUSInactive
Code: I4807BK602Class: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EUClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULRClass: IACT