NDC 0591-2067

risedronate sodium

Risedronate Sodium

risedronate sodium is a Oral Tablet, Film Coated 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 ID0591-2067_41414f92-4457-410b-896b-9cf835a125b5
NDC0591-2067
Product TypeHuman Prescription Drug
Proprietary Namerisedronate sodium
Generic NameRisedronate Sodium
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2014-06-27
Marketing CategoryNDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
Application NumberNDA020835
Labeler NameActavis Pharma, Inc.
Substance NameRISEDRONATE SODIUM HEMI-PENTAHYDRATE; RISEDRONATE SODIUM MONOHYDRATE
Active Ingredient Strength65 mg/1; mg/1
Pharm ClassesBisphosphonate [EPC],Diphosphonates [CS],Bisphosphonate [EPC],Diphosphonates [CS]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0591-2067-02

2 TABLET, FILM COATED in 1 DOSE PACK (0591-2067-02)
Marketing Start Date2014-06-27
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0591-2067-02 [00591206702]

risedronate sodium TABLET, FILM COATED
Marketing CategoryNDA AUTHORIZED GENERIC
Application NumberNDA020835
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-06-27

Drug Details

Active Ingredients

IngredientStrength
RISEDRONATE SODIUM HEMI-PENTAHYDRATE64.5 mg/1

OpenFDA Data

SPL SET ID:1d33f2ef-ec29-47b1-a1ce-8b1583c65ab4
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 905024
  • 905032
  • 905100
  • 905028
  • 905083
  • 905092
  • 905041
  • UPC Code
  • 0305912102300
  • 0305912109309
  • 0305912044549
  • 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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