Rimantadine Hydrochloride
RIMANTADINE HYDROCHLORIDE TABLETS, 100 MG
Approved
Approval ID
48842cd7-2d78-455a-a688-b148347b6dd5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 12, 2011
Manufacturers
FDA
H.J. Harkins Company, Inc.
DUNS: 147681894
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Rimantadine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code52959-305
Application NumberANDA076132
Product Classification
M
Marketing Category
C73584
G
Generic Name
Rimantadine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 12, 2011
FDA Product Classification
INGREDIENTS (7)
Rimantadine HydrochlorideActive
Quantity: 100 mg in 1 1
Code: JEI07OOS8Y
Classification: ACTIB
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT