NDC 65862-861

Darifenacin

Darifenacin

Darifenacin is a Oral Tablet, Film Coated, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Aurobindo Pharma Limited. The primary component is Darifenacin Hydrobromide.

Product ID65862-861_33d64295-2f71-4d67-bf13-efdfc364c3d7
NDC65862-861
Product TypeHuman Prescription Drug
Proprietary NameDarifenacin
Generic NameDarifenacin
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2016-09-19
Marketing CategoryANDA / ANDA
Application NumberANDA206743
Labeler NameAurobindo Pharma Limited
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 65862-861-05

500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-861-05)
Marketing Start Date2016-09-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65862-861-99 [65862086199]

Darifenacin TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA206743
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-09-19

NDC 65862-861-30 [65862086130]

Darifenacin TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA206743
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-09-19

NDC 65862-861-90 [65862086190]

Darifenacin TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA206743
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-09-19

NDC 65862-861-05 [65862086105]

Darifenacin TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA206743
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-09-19

Drug Details

Active Ingredients

IngredientStrength
DARIFENACIN HYDROBROMIDE7.5 mg/1

OpenFDA Data

SPL SET ID:28ed5b58-46dd-4140-a877-4b422f780a94
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 485423
  • 485421
    • UPC Code
  • 0365862862303

    • Pharmacological Class

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

    Medicade Reported Pricing

    65862086130 DARIFENACIN ER 7.5 MG TABLET

    Pricing Unit: EA | Drug Type:

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

    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
    52605-068DarifenacinDarifenacin Hydrobromide
    59746-516darifenacindarifenacin hydrobromide
    59746-517darifenacindarifenacin hydrobromide
    62332-223DARIFENACINDARIFENACIN
    69097-432DarifenacinDarifenacin
    69097-431DarifenacinDarifenacin
    62332-224DARIFENACINDARIFENACIN
    65862-862DarifenacinDarifenacin
    65862-861DarifenacinDarifenacin
    0430-0170Enablexdarifenacin
    0430-0171Enablexdarifenacin
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