NDC 0430-0478

Actonel

Risedronate Sodium

Actonel is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Allergan, Inc.. The primary component is Risedronate Sodium Hemi-pentahydrate; Risedronate Sodium Monohydrate.

Product ID0430-0478_0a53e1f4-98c8-4ea5-be4a-d1a9709bdc60
NDC0430-0478
Product TypeHuman Prescription Drug
Proprietary NameActonel
Generic NameRisedronate Sodium
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2008-04-22
Marketing CategoryNDA / NDA
Application NumberNDA020835
Labeler NameAllergan, Inc.
Substance NameRISEDRONATE SODIUM HEMI-PENTAHYDRATE; RISEDRONATE SODIUM MONOHYDRATE
Active Ingredient Strength129 mg/1; mg/1
Pharm ClassesBisphosphonate [EPC],Diphosphonates [CS],Bisphosphonate [EPC],Diphosphonates [CS]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0430-0478-01

1 TABLET, FILM COATED in 1 DOSE PACK (0430-0478-01)
Marketing Start Date2008-04-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0430-0478-02 [00430047802]

Actonel TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA020835
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2008-04-22

NDC 0430-0478-01 [00430047801]

Actonel TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA020835
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2008-04-22

NDC 0430-0478-95 [00430047895]

Actonel TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA020835
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-05-16
Marketing End Date2015-05-19

Drug Details

Active Ingredients

IngredientStrength
RISEDRONATE SODIUM HEMI-PENTAHYDRATE129 mg/1

OpenFDA Data

SPL SET ID:24ed00e0-25e2-49a8-97fc-66c1b417dc0b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 905024
  • 905032
  • 905026
  • 905030
  • 905100
  • 905034
  • 905028
  • 905101
  • 905083
  • 905093
  • 905092
  • 905086
  • 905043
  • 905084
  • 905041
  • 905087

    • Pharmacological Class

    • Bisphosphonate [EPC]
    • Diphosphonates [CS]
    • Bisphosphonate [EPC]
    • Diphosphonates [CS]

    NDC Crossover Matching brand name "Actonel" or generic name "Risedronate Sodium"

    NDCBrand NameGeneric Name
    0149-0470ACTONELRISEDRONATE SODIUM
    0149-0471ACTONELRISEDRONATE SODIUM
    0149-0472ACTONELRISEDRONATE SODIUM
    0149-0478ACTONELRISEDRONATE SODIUM
    0430-0470ActonelRisedronate Sodium
    0430-0471ActonelRisedronate Sodium
    0430-0472ActonelRisedronate Sodium
    0430-0478ActonelRisedronate Sodium
    0093-3098Risedronate SodiumRisedronate Sodium
    0093-3099Risedronate SodiumRisedronate Sodium
    0093-3100Risedronate SodiumRisedronate Sodium
    0093-7771Risedronate SodiumRisedronate Sodium
    0378-4044Risedronate Sodiumrisedronate sodium
    0378-4114Risedronate Sodiumrisedronate sodium
    0378-4150Risedronate Sodiumrisedronate sodium
    0378-4714Risedronate Sodiumrisedronate sodium

    Trademark Results [Actonel]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ACTONEL
    ACTONEL
    75237477 2215222 Live/Registered
    ALLERGAN PHARMACEUTICALS INTERNATIONAL L
    1997-02-06
    ACTONEL
    ACTONEL
    74603273 not registered Dead/Abandoned
    Procter & Gamble Company, The
    1994-11-09
    ACTONEL
    ACTONEL
    74010973 1608809 Dead/Cancelled
    NORWICH EATON PHARMACEUTICALS, INC.
    1989-12-15
    ACTONEL
    ACTONEL
    73768517 1560433 Dead/Cancelled
    NORWICH EATON PHARMACEUTICALS, INC.
    1988-12-09
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