Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
American Health Packaging
American Health Packaging
929561009
Products2
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
68084-220Application Number
ANDA078539Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
August 1, 2023ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
TRIACETINInactive
Code: XHX3C3X673Class: IACT
OndansetronActive
Code: NMH84OZK2BClass: ACTIMQuantity: 4 mg in 1 1
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6Class: IACT
Ondansetron Hydrochloride
Product Details
NDC Product Code
68084-221Application Number
ANDA078539Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
August 1, 2023ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
TRIACETINInactive
Code: XHX3C3X673Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6Class: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
OndansetronActive
Code: NMH84OZK2BClass: ACTIMQuantity: 8 mg in 1 1