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, USP, for oral use Initial U.S. Approval: 1998
Approved
Approval ID
62aff8d6-a2f7-4c7e-a102-c70105ac3792
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 1, 2023
Manufacturers
FDA
Macleods Pharmaceuticals Limited
DUNS: 862128535
Products 3
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 Code33342-108
Application NumberANDA203533
Product Classification
M
Marketing Category
C73584
G
Generic Name
Risedronate Sodium
Product Specifications
Route of AdministrationORAL
Effective DateAugust 1, 2023
FDA Product Classification
INGREDIENTS (10)
RISEDRONATE SODIUMActive
Quantity: 30 mg in 1 1
Code: OFG5EXG60L
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
Risedronate Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code33342-107
Application NumberANDA203533
Product Classification
M
Marketing Category
C73584
G
Generic Name
Risedronate Sodium
Product Specifications
Route of AdministrationORAL
Effective DateAugust 1, 2023
FDA Product Classification
INGREDIENTS (11)
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
RISEDRONATE SODIUMActive
Quantity: 5 mg in 1 1
Code: OFG5EXG60L
Classification: ACTIB
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
Risedronate Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code33342-109
Application NumberANDA203533
Product Classification
M
Marketing Category
C73584
G
Generic Name
Risedronate Sodium
Product Specifications
Route of AdministrationORAL
Effective DateAugust 1, 2023
FDA Product Classification
INGREDIENTS (12)
RISEDRONATE SODIUMActive
Quantity: 35 mg in 1 1
Code: OFG5EXG60L
Classification: ACTIB
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT