NDC 0591-3876

Risedronate Sodium

Risedronate Sodium

Risedronate Sodium is a Oral Tablet, Delayed Release in the Human Prescription Drug category. It is labeled and distributed by Actavis Pharma, Inc.. The primary component is Risedronate Sodium Hemi-pentahydrate; Risedronate Sodium Monohydrate.

Product ID0591-3876_cbad3736-ad79-475b-b35d-b9fce4923650
NDC0591-3876
Product TypeHuman Prescription Drug
Proprietary NameRisedronate Sodium
Generic NameRisedronate Sodium
Dosage FormTablet, Delayed Release
Route of AdministrationORAL
Marketing Start Date2010-12-01
Marketing CategoryNDA / NDA
Application NumberNDA022560
Labeler NameActavis Pharma, 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 Through2020-12-31

Packaging

NDC 0591-3876-04

4 TABLET, DELAYED RELEASE in 1 DOSE PACK (0591-3876-04)
Marketing Start Date2010-12-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0591-3876-04 [00591387604]

Risedronate Sodium TABLET, DELAYED RELEASE
Marketing CategoryNDA
Application NumberNDA022560
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-12-01
Marketing End Date2019-05-31

Drug Details

Active Ingredients

IngredientStrength
RISEDRONATE SODIUM HEMI-PENTAHYDRATE30.1 mg/1

OpenFDA Data

SPL SET ID:ef2dbc86-b4f5-4990-a83f-0b121cfe2ec1
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1020064
  • 1020065
  • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    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
    0591-2067risedronate sodiumrisedronate sodium
    0591-2109risedronate sodiumrisedronate sodium
    0591-2075risedronate sodiumrisedronate sodium
    0591-2044risedronate sodiumrisedronate sodium
    0591-2102risedronate sodiumrisedronate sodium
    0591-3876Risedronate SodiumRisedronate Sodium
    33342-107Risedronate SodiumRisedronate Sodium
    33342-109Risedronate SodiumRisedronate Sodium
    33342-108Risedronate SodiumRisedronate Sodium
    47335-666risedronate sodiumrisedronate sodium
    47335-667risedronate sodiumrisedronate sodium
    47335-928risedronate sodiumrisedronate sodium
    47335-727risedronate sodiumrisedronate sodium
    47335-668risedronate sodiumrisedronate sodium
    59762-0405Risedronate SodiumRisedronate Sodium
    59762-0406Risedronate SodiumRisedronate Sodium
    59762-0407Risedronate SodiumRisedronate Sodium
    60505-3165Risedronate SodiumRisedronate Sodium
    60723-041Risedronate SodiumRisedronate Sodium
    60505-3096Risedronate SodiumRisedronate Sodium
    60505-3097Risedronate SodiumRisedronate Sodium
    65862-517Risedronate SodiumRisedronate Sodium
    65862-518Risedronate SodiumRisedronate Sodium
    65862-519Risedronate SodiumRisedronate Sodium
    65862-870Risedronate SodiumRisedronate Sodium
    68382-075Risedronate SodiumRisedronate Sodium
    70771-1436Risedronate SodiumRisedronate Sodium
    63304-440RISEDRONATE SODIUMRISEDRONATE SODIUM
    0149-0470ACTONELRISEDRONATE SODIUM
    0149-0471ACTONELRISEDRONATE SODIUM
    0149-0472ACTONELRISEDRONATE SODIUM
    0149-0478ACTONELRISEDRONATE SODIUM
    0430-0470ActonelRisedronate Sodium
    0430-0471ActonelRisedronate Sodium
    0430-0472ActonelRisedronate Sodium
    0430-0478ActonelRisedronate Sodium

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