NDC 69097-432

Darifenacin

Darifenacin Hydrobromide

Darifenacin is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Cipla Usa Inc.. The primary component is Darifenacin Hydrobromide.

Product ID69097-432_3445600a-f4f9-4d23-8a82-e4d5b7a9814b
NDC69097-432
Product TypeHuman Prescription Drug
Proprietary NameDarifenacin
Generic NameDarifenacin Hydrobromide
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2016-09-01
Marketing CategoryANDA / ANDA
Application NumberANDA207664
Labeler NameCipla USA 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 69097-432-02

30 TABLET, EXTENDED RELEASE in 1 BOTTLE (69097-432-02)
Marketing Start Date2016-09-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69097-432-02 [69097043202]

Darifenacin TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA207664
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-09-01

NDC 69097-432-15 [69097043215]

Darifenacin TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA207664
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-09-01

NDC 69097-432-05 [69097043205]

Darifenacin TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA207664
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-09-01

Drug Details

Active Ingredients

IngredientStrength
DARIFENACIN HYDROBROMIDE15 mg/1

OpenFDA Data

SPL SET ID:6e8470d1-c3e6-4644-b70a-aa47ddf79676
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 485423
  • 485421
    • UPC Code
  • 0369097432027
  • 0369097431020

    • Pharmacological Class

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

    Medicade Reported Pricing

    69097043205 DARIFENACIN ER 15 MG TABLET

    Pricing Unit: EA | Drug Type:

    69097043202 DARIFENACIN ER 15 MG TABLET

    Pricing Unit: EA | Drug Type:

    NDC Crossover Matching brand name "Darifenacin" or generic name "Darifenacin Hydrobromide"

    NDCBrand NameGeneric Name
    0591-4375Darifenacindarifenacin
    0591-4380Darifenacindarifenacin
    13668-202DarifenacinDarifenacin
    13668-203DarifenacinDarifenacin
    16571-767DarifenacinDarifenacin
    16571-768DarifenacinDarifenacin
    33342-276DarifenacinDarifenacin
    33342-277DarifenacinDarifenacin
    46708-223DARIFENACINDARIFENACIN
    46708-224DARIFENACINDARIFENACIN
    52605-067DarifenacinDarifenacin Hydrobromide
    69097-432DarifenacinDarifenacin
    69097-431DarifenacinDarifenacin
    59746-517darifenacindarifenacin
    59746-516darifenacindarifenacin
    62332-224DARIFENACINDARIFENACIN
    62332-223DARIFENACINDARIFENACIN
    65862-862DarifenacinDarifenacin
    65862-861DarifenacinDarifenacin
    52605-068DarifenacinDarifenacin
    10370-170Darifenacin HydrobromideDarifenacin Hydrobromide
    10370-171Darifenacin HydrobromideDarifenacin Hydrobromide
    42291-206Darifenacin HydrobromideDarifenacin Hydrobromide
    42291-207Darifenacin HydrobromideDarifenacin Hydrobromide
    0430-0170Enablexdarifenacin
    0430-0171Enablexdarifenacin
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.