Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
PSS World Medical, Inc.
101822682
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Dispensing Solutions, Inc.
Dispensing Solutions, Inc.
PSS World Medical, Inc.
066070785
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
55045-3817Application Number
ANDA077050Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
November 5, 2013ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
OndansetronActive
Code: NMH84OZK2BClass: ACTIMQuantity: 8 mg in 1 1
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQClass: IACT
ONDANSETRON HYDROCHLORIDE
Product Details
NDC Product Code
55045-3729Application Number
ANDA077050Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
November 5, 2013HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQClass: IACT
OndansetronActive
Code: NMH84OZK2BClass: ACTIMQuantity: 4 mg in 1 1
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT