NDC 33342-108

Risedronate Sodium

Risedronate Sodium

Risedronate Sodium is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Macleods Pharmaceuticals Limited. The primary component is Risedronate Sodium.

Product ID33342-108_0c7b89bb-35e4-4482-b0bd-1802bcd4985e
NDC33342-108
Product TypeHuman Prescription Drug
Proprietary NameRisedronate Sodium
Generic NameRisedronate Sodium
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2015-12-09
Marketing CategoryANDA / ANDA
Application NumberANDA203533
Labeler NameMacleods Pharmaceuticals Limited
Substance NameRISEDRONATE SODIUM
Active Ingredient Strength30 mg/1
Pharm ClassesBisphosphonate [EPC], Diphosphonates [CS]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 33342-108-06

3 BLISTER PACK in 1 CARTON (33342-108-06) > 10 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Start Date2015-12-09
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 33342-108-15 [33342010815]

Risedronate Sodium TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA203533
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-12-09

NDC 33342-108-07 [33342010807]

Risedronate Sodium TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA203533
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-12-09

NDC 33342-108-06 [33342010806]

Risedronate Sodium TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA203533
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-12-09

Drug Details

Active Ingredients

IngredientStrength
RISEDRONATE SODIUM30 mg/1

OpenFDA Data

SPL SET ID:62aff8d6-a2f7-4c7e-a102-c70105ac3792
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 905024
  • 905032
  • 905092
  • 905100
  • 905041
  • Pharmacological Class

    • 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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