Manufacturing Establishments3
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Impax Laboratories Inc
H.J. Harkins Company, Inc.
790947167
Global Pharmaceuticals, Division of Impax Laboratories Inc.
H.J. Harkins Company, Inc.
116732830
Impax Laboratories Taiwan Inc.
H.J. Harkins Company, Inc.
656139511
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Rimantadine Hydrochloride
Product Details
NDC Product Code
52959-305Application Number
ANDA076132Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
September 12, 2011RimantadineActive
Code: JEI07OOS8YClass: ACTIBQuantity: 100 mg in 1 1
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1AClass: IACT