Rimantadine Hydrochloride
RIMANTADINE HYDROCHLORIDE TABLETS, 100 MG
Approved
Approval ID
08d7b0df-a353-49a0-92ac-64028d4084b7
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 14, 2012
Manufacturers
FDA
STAT Rx USA LLC
DUNS: 786036330
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 Code16590-202
Application NumberANDA076132
Product Classification
M
Marketing Category
C73584
G
Generic Name
Rimantadine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateAugust 14, 2012
FDA Product Classification
INGREDIENTS (7)
Rimantadine HydrochlorideActive
Quantity: 100 mg in 1 1
Code: JEI07OOS8Y
Classification: ACTIB
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT