NDC 60429-851

Darifenacin Hydrobromide Extended-Release

Darifenacin Hydrobromide

Darifenacin Hydrobromide Extended-Release is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Golden State Medical Supply, Inc.. The primary component is Darifenacin Hydrobromide.

Product ID60429-851_7c723daa-df5f-2956-e053-2991aa0a91dd
NDC60429-851
Product TypeHuman Prescription Drug
Proprietary NameDarifenacin Hydrobromide Extended-Release
Generic NameDarifenacin Hydrobromide
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2017-01-18
Marketing CategoryANDA / ANDA
Application NumberANDA091190
Labeler NameGolden State Medical Supply, Inc.
Substance NameDARIFENACIN HYDROBROMIDE
Active Ingredient Strength15 mg/1
Pharm ClassesCholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 60429-851-30

30 TABLET, EXTENDED RELEASE in 1 BOTTLE (60429-851-30)
Marketing Start Date2017-01-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 60429-851-30 [60429085130]

Darifenacin Hydrobromide Extended-Release TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA091190
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-01-18

Drug Details

Active Ingredients

IngredientStrength
DARIFENACIN HYDROBROMIDE15 mg/1

OpenFDA Data

SPL SET ID:c14b3cc1-6463-4da2-abd6-ec849313931d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 485423
  • 485421
  • Pharmacological Class

    • Cholinergic Muscarinic Antagonist [EPC]
    • Cholinergic Muscarinic Antagonists [MoA]
    • Cholinergic Muscarinic Antagonist [EPC]
    • Cholinergic Muscarinic Antagonists [MoA]

    NDC Crossover Matching brand name "Darifenacin Hydrobromide Extended-Release" or generic name "Darifenacin Hydrobromide"

    NDCBrand NameGeneric Name
    52605-067DarifenacinDarifenacin Hydrobromide
    52605-068DarifenacinDarifenacin Hydrobromide
    59746-516darifenacindarifenacin hydrobromide
    59746-517darifenacindarifenacin hydrobromide
    69097-431DarifenacinDarifenacin Hydrobromide
    69097-432DarifenacinDarifenacin Hydrobromide
    70700-183Darifenacin 15 mgDarifenacin Hydrobromide
    70700-182Darifenacin 7.5 mgDarifenacin Hydrobromide
    10370-170Darifenacin HydrobromideDarifenacin Hydrobromide
    10370-171Darifenacin HydrobromideDarifenacin Hydrobromide
    42291-206Darifenacin HydrobromideDarifenacin Hydrobromide
    42291-207Darifenacin HydrobromideDarifenacin Hydrobromide
    60429-850Darifenacin HydrobromideDarifenacin Hydrobromide
    60429-851Darifenacin HydrobromideDarifenacin Hydrobromide

    © 2021 FDA.report
    This site is not affiliated with or endorsed by the FDA.