NDC 10370-170

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 Par Pharmaceutical, Inc.. The primary component is Darifenacin Hydrobromide.

Product ID10370-170_0b87676b-9f51-437e-af66-edb1cba050ab
NDC10370-170
Product TypeHuman Prescription Drug
Proprietary NameDarifenacin Hydrobromide Extended-Release
Generic NameDarifenacin Hydrobromide
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2016-03-15
Marketing CategoryANDA / ANDA
Application NumberANDA091190
Labeler NamePar Pharmaceutical, Inc.
Substance NameDARIFENACIN HYDROBROMIDE
Active Ingredient Strength8 mg/1
Pharm ClassesCholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 10370-170-09

90 TABLET, EXTENDED RELEASE in 1 BOTTLE (10370-170-09)
Marketing Start Date2016-03-15
Marketing End Date2021-02-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 10370-170-11 [10370017011]

Darifenacin Hydrobromide Extended-Release TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA091190
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-03-15
Marketing End Date2021-02-28

NDC 10370-170-09 [10370017009]

Darifenacin Hydrobromide Extended-Release TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA091190
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-03-15
Marketing End Date2021-02-28

Drug Details

Active Ingredients

IngredientStrength
DARIFENACIN HYDROBROMIDE7.5 mg/1

OpenFDA Data

SPL SET ID:74921ebb-c5e8-4ae3-9ef5-33c15d6522ac
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 485423
  • 485421
    • UPC Code
  • 0349884123451

    • Pharmacological Class

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

    Medicade Reported Pricing

    10370017011 DARIFENACIN ER 7.5 MG TABLET

    Pricing Unit: EA | Drug Type:

    10370017009 DARIFENACIN ER 7.5 MG TABLET

    Pricing Unit: EA | Drug Type:

    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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