Actonel

Products5

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Product Details

NDC Product Code

0430-0477

Application Number

NDA020835

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

November 21, 2023

Ingredients

CROSPOVIDONEInactive

Code: 2S7830E561Class: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive

Code: RFW2ET671PClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

Colecalciferol/Risedronate SodiumActive

Code: F67L43UT5CClass: ACTIRQuantity: 10.5 mg in 1 1

Risedronic acidActive

Code: HU2YAQ274OClass: ACTIRQuantity: 64.5 mg in 1 1

Actonel

Product Details

NDC Product Code

0430-0478

Application Number

NDA020835

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

November 21, 2023

Ingredients

Risedronic acidActive

Code: HU2YAQ274OClass: ACTIRQuantity: 129 mg in 1 1

CROSPOVIDONEInactive

Code: 2S7830E561Class: IACT

HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive

Code: RFW2ET671PClass: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQKClass: IACT

Colecalciferol/Risedronate SodiumActive

Code: F67L43UT5CClass: ACTIRQuantity: 21 mg in 1 1

Actonel

Product Details

NDC Product Code

0430-0472

Application Number

NDA020835

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

November 21, 2023

Ingredients

CROSPOVIDONEInactive

Code: 2S7830E561Class: IACT

HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive

Code: RFW2ET671PClass: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

Risedronic acidActive

Code: HU2YAQ274OClass: ACTIRQuantity: 30.1 mg in 1 1

Colecalciferol/Risedronate SodiumActive

Code: F67L43UT5CClass: ACTIRQuantity: 4.9 mg in 1 1

Actonel

Product Details

NDC Product Code

0430-0471

Application Number

NDA020835

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

November 21, 2023

Ingredients

CROSPOVIDONEInactive

Code: 2S7830E561Class: IACT

HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive

Code: RFW2ET671PClass: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

Risedronic acidActive

Code: HU2YAQ274OClass: ACTIRQuantity: 4.3 mg in 1 1

Colecalciferol/Risedronate SodiumActive

Code: F67L43UT5CClass: ACTIRQuantity: 0.7 mg in 1 1

Actonel

Product Details

NDC Product Code

0430-0470

Application Number

NDA020835

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

November 21, 2023

Ingredients

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

CROSPOVIDONEInactive

Code: 2S7830E561Class: IACT

HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive

Code: RFW2ET671PClass: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

Risedronic acidActive

Code: HU2YAQ274OClass: ACTIRQuantity: 25.8 mg in 1 1

Colecalciferol/Risedronate SodiumActive

Code: F67L43UT5CClass: ACTIRQuantity: 4.2 mg in 1 1

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Actonel

FDA Approval Summary

Products5

Actonel

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Actonel

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Actonel

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Actonel

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Actonel

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