Actonel
These highlights do not include all the information needed to use ACTONEL safely and effectively. See full prescribing information for ACTONEL. ACTONEL ( risedronate sodium ) tablets , for oral use Initial U.S. Approval: 199 8
Approved
Approval ID
24ed00e0-25e2-49a8-97fc-66c1b417dc0b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 1, 2023
Manufacturers
FDA
Allergan, Inc.
DUNS: 144796497
Products 5
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 Code0430-0477
Application NumberNDA020835
Product Classification
M
Marketing Category
C73594
G
Generic Name
Risedronate Sodium
Product Specifications
Route of AdministrationORAL
Effective DateNovember 21, 2023
FDA Product Classification
INGREDIENTS (11)
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
RISEDRONATE SODIUM MONOHYDRATEActive
Quantity: 10.5 mg in 1 1
Code: F67L43UT5C
Classification: ACTIR
RISEDRONATE SODIUM HEMI-PENTAHYDRATEActive
Quantity: 64.5 mg in 1 1
Code: HU2YAQ274O
Classification: ACTIR
Risedronate Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0430-0478
Application NumberNDA020835
Product Classification
M
Marketing Category
C73594
G
Generic Name
Risedronate Sodium
Product Specifications
Route of AdministrationORAL
Effective DateNovember 21, 2023
FDA Product Classification
INGREDIENTS (11)
RISEDRONATE SODIUM HEMI-PENTAHYDRATEActive
Quantity: 129 mg in 1 1
Code: HU2YAQ274O
Classification: ACTIR
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
RISEDRONATE SODIUM MONOHYDRATEActive
Quantity: 21 mg in 1 1
Code: F67L43UT5C
Classification: ACTIR
Risedronate Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0430-0472
Application NumberNDA020835
Product Classification
M
Marketing Category
C73594
G
Generic Name
Risedronate Sodium
Product Specifications
Route of AdministrationORAL
Effective DateNovember 21, 2023
FDA Product Classification
INGREDIENTS (13)
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
RISEDRONATE SODIUM HEMI-PENTAHYDRATEActive
Quantity: 30.1 mg in 1 1
Code: HU2YAQ274O
Classification: ACTIR
RISEDRONATE SODIUM MONOHYDRATEActive
Quantity: 4.9 mg in 1 1
Code: F67L43UT5C
Classification: ACTIR
Risedronate Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0430-0471
Application NumberNDA020835
Product Classification
M
Marketing Category
C73594
G
Generic Name
Risedronate Sodium
Product Specifications
Route of AdministrationORAL
Effective DateNovember 21, 2023
FDA Product Classification
INGREDIENTS (12)
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
RISEDRONATE SODIUM HEMI-PENTAHYDRATEActive
Quantity: 4.3 mg in 1 1
Code: HU2YAQ274O
Classification: ACTIR
RISEDRONATE SODIUM MONOHYDRATEActive
Quantity: 0.7 mg in 1 1
Code: F67L43UT5C
Classification: ACTIR
Risedronate Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0430-0470
Application NumberNDA020835
Product Classification
M
Marketing Category
C73594
G
Generic Name
Risedronate Sodium
Product Specifications
Route of AdministrationORAL
Effective DateNovember 21, 2023
FDA Product Classification
INGREDIENTS (11)
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
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
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
RISEDRONATE SODIUM HEMI-PENTAHYDRATEActive
Quantity: 25.8 mg in 1 1
Code: HU2YAQ274O
Classification: ACTIR
RISEDRONATE SODIUM MONOHYDRATEActive
Quantity: 4.2 mg in 1 1
Code: F67L43UT5C
Classification: ACTIR