Risedronate Sodium
These highlights do not include all the information needed to use RISEDRONATE SODIUM TABLETS, USP safely and effectively. See Full Prescribing Information for SODIUM TABLETS, USP. RISEDRONATE SODIUM tablets, for oral useInitial U.S. Approval: 1998
Approved
Approval ID
b90f2e5b-10b8-29a7-0360-31bd0dae0ec2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 15, 2023
Manufacturers
FDA
Apotex Corp.
DUNS: 845263701
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 Code60505-3096
Application NumberANDA090877
Product Classification
M
Marketing Category
C73584
G
Generic Name
Risedronate Sodium
Product Specifications
Route of AdministrationORAL
Effective DateDecember 15, 2023
FDA Product Classification
INGREDIENTS (10)
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
RISEDRONATE SODIUMActive
Quantity: 75 mg in 1 1
Code: OFG5EXG60L
Classification: ACTIB
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
Risedronate Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60505-3165
Application NumberANDA090877
Product Classification
M
Marketing Category
C73584
G
Generic Name
Risedronate Sodium
Product Specifications
Route of AdministrationORAL
Effective DateDecember 15, 2023
FDA Product Classification
INGREDIENTS (11)
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
RISEDRONATE SODIUMActive
Quantity: 35 mg in 1 1
Code: OFG5EXG60L
Classification: ACTIB
Risedronate Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60505-3097
Application NumberANDA090877
Product Classification
M
Marketing Category
C73584
G
Generic Name
Risedronate Sodium
Product Specifications
Route of AdministrationORAL
Effective DateDecember 15, 2023
FDA Product Classification
INGREDIENTS (12)
RISEDRONATE SODIUMActive
Quantity: 150 mg in 1 1
Code: OFG5EXG60L
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEInactive
Code: 593YOG76RN
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORMInactive
Code: GR686LBA74
Classification: IACT