Risedronate Sodium
These highlights do not include all the information needed to use RISEDRONATE SODIUM TABLETS safely and effectively. See Full Prescribing Information for RISEDRONATE SODIUM TABLETS. RISEDRONATE SODIUM tablets, for oral use Initial U.S. Approval: 1998
Approved
Approval ID
d60a56cb-ef49-4447-9043-7b6879a20d75
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 16, 2023
Manufacturers
FDA
Hangzhou Minsheng Binjiang Pharmaceutical CO., Ltd
DUNS: 547688780
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Risedronate Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60723-041
Application NumberANDA207516
Product Classification
M
Marketing Category
C73584
G
Generic Name
Risedronate Sodium
Product Specifications
Route of AdministrationORAL
Effective DateNovember 16, 2023
FDA Product Classification
INGREDIENTS (10)
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
RISEDRONATE SODIUM HEMI-PENTAHYDRATEActive
Quantity: 35 mg in 1 1
Code: HU2YAQ274O
Classification: ACTIR