Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
DOH CENTRAL PHARMACY
DOH CENTRAL PHARMACY
829348114
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
53808-1121Application Number
ANDA078539Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
January 22, 2019STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
TRIACETINInactive
Code: XHX3C3X673Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6Class: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
OndansetronActive
Code: NMH84OZK2BClass: ACTIMQuantity: 4 mg in 1 1
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT