NDC 0430-0979

Atelvia

Risedronate Sodium

Atelvia is a Oral Tablet, Delayed Release 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 ID0430-0979_4dca2c74-6467-4934-96f1-ec555c24ede7
NDC0430-0979
Product TypeHuman Prescription Drug
Proprietary NameAtelvia
Generic NameRisedronate Sodium
Dosage FormTablet, Delayed Release
Route of AdministrationORAL
Marketing Start Date2010-12-01
Marketing CategoryNDA / NDA
Application NumberNDA022560
Labeler NameAllergan, Inc.
Substance NameRISEDRONATE SODIUM HEMI-PENTAHYDRATE; RISEDRONATE SODIUM MONOHYDRATE
Active Ingredient Strength30 mg/1; mg/1
Pharm ClassesBisphosphonate [EPC],Diphosphonates [CS],Bisphosphonate [EPC],Diphosphonates [CS]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0430-0979-03

4 TABLET, DELAYED RELEASE in 1 DOSE PACK (0430-0979-03)
Marketing Start Date2010-12-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0430-0979-95 [00430097995]

Atelvia TABLET, DELAYED RELEASE
Marketing CategoryNDA
Application NumberNDA022560
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-12-01
Marketing End Date2015-05-19

NDC 0430-0979-03 [00430097903]

Atelvia TABLET, DELAYED RELEASE
Marketing CategoryNDA
Application NumberNDA022560
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-12-01

Drug Details

Active Ingredients

IngredientStrength
RISEDRONATE SODIUM HEMI-PENTAHYDRATE30.1 mg/1

OpenFDA Data

SPL SET ID:c8b9ab88-1a26-46c3-80ec-4eaa45202021
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1020066
  • 1020064
  • 1020065

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    0430-0979AtelviaAtelvia
    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 [Atelvia]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ATELVIA
    ATELVIA
    85001017 3946064 Live/Registered
    ALLERGAN PHARMACEUTICALS INTERNATIONAL LIMITED
    2010-03-29
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