Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Hikma Pharmaceuticals USA Inc.
001230762
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ondansetron
Product Details
NDC Product Code
0641-6080Application Number
ANDA077541Marketing Category
ANDA (C73584)Route of Administration
INTRAMUSCULAR, INTRAVENOUSEffective Date
April 1, 2022CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QPClass: IACTQuantity: 0.5 mg in 1 mL
OndansetronActive
Code: NMH84OZK2BClass: ACTIMQuantity: 2 mg in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 9 mg in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95KClass: IACTQuantity: 0.25 mg in 1 mL