NDC 59746-516

darifenacin

Darifenacin Hydrobromide

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

Product ID59746-516_7ed533b1-0dcb-4ed4-a702-d998183568a0
NDC59746-516
Product TypeHuman Prescription Drug
Proprietary Namedarifenacin
Generic NameDarifenacin Hydrobromide
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2016-10-12
Marketing CategoryANDA / ANDA
Application NumberANDA205550
Labeler NameJubilant Cadista Pharmaceuticals Inc.
Substance NameDARIFENACIN HYDROBROMIDE
Active Ingredient Strength8 mg/1
Pharm ClassesCholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 59746-516-01

100 TABLET, EXTENDED RELEASE in 1 BOTTLE (59746-516-01)
Marketing Start Date2016-10-12
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 59746-516-01 [59746051601]

darifenacin TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA205550
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-10-12

NDC 59746-516-30 [59746051630]

darifenacin TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA205550
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-10-12

NDC 59746-516-07 [59746051607]

darifenacin TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA205550
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-10-12
Marketing End Date2017-09-25

NDC 59746-516-10 [59746051610]

darifenacin TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA205550
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-10-12

NDC 59746-516-90 [59746051690]

darifenacin TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA205550
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-10-12

Drug Details

Active Ingredients

IngredientStrength
DARIFENACIN HYDROBROMIDE7.5 mg/1

OpenFDA Data

SPL SET ID:746ef6fe-0472-c41c-d445-cfeeab1a11d0
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 485423
  • 485421
    • UPC Code
  • 0359746516307
  • 0359746517304

    • Pharmacological Class

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

    Medicade Reported Pricing

    59746051690 DARIFENACIN ER 7.5 MG TABLET

    Pricing Unit: EA | Drug Type:

    59746051630 DARIFENACIN ER 7.5 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
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