Rimantadine Hydrochloride
Rimantadine Hydrochloride Tablets, USP (100 mg) Rx Only
Approved
Approval ID
49f7d69a-820b-4c75-a31d-b2104c019c12
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 31, 2023
Manufacturers
FDA
Amneal Pharmaceuticals of New York LLC
DUNS: 123797875
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 Code0115-1911
Application NumberANDA076132
Product Classification
M
Marketing Category
C73584
G
Generic Name
Rimantadine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 31, 2023
FDA Product Classification
INGREDIENTS (7)
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
RIMANTADINE HYDROCHLORIDEActive
Quantity: 100 mg in 1 1
Code: JEI07OOS8Y
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT