NDC 42291-207

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 Avkare, Inc.. The primary component is Darifenacin Hydrobromide.

Product ID42291-207_63139afe-50e3-ae4a-e053-2991aa0a48f0
NDC42291-207
Product TypeHuman Prescription Drug
Proprietary NameDarifenacin Hydrobromide Extended-Release
Generic NameDarifenacin Hydrobromide
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2017-01-09
Marketing CategoryANDA / ANDA
Application NumberANDA091190
Labeler NameAvKARE, Inc.
Substance NameDARIFENACIN HYDROBROMIDE
Active Ingredient Strength15 mg/1
Pharm ClassesCholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 42291-207-90

90 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-207-90)
Marketing Start Date2017-01-09
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 42291-207-90 [42291020790]

Darifenacin Hydrobromide Extended-Release TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA091190
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-01-09
Marketing End Date2020-03-13

Drug Details

Active Ingredients

IngredientStrength
DARIFENACIN HYDROBROMIDE15 mg/1

OpenFDA Data

SPL SET ID:b45c0f77-66c4-42ac-8e90-48bdba103132
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 485423
  • 485421
    • UPC Code
  • 0342291206908
  • 0342291207905

    • Pharmacological Class

    • 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
    71205-901Darifenacin 15 mgDarifenacin Hydrobromide
    70700-182Darifenacin 7.5 mgDarifenacin Hydrobromide
    71205-900Darifenacin 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
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