NDC 13668-202

Darifenacin

Darifenacin

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

Product ID13668-202_947df1f4-effb-37cf-e053-2995a90a26ea
NDC13668-202
Product TypeHuman Prescription Drug
Proprietary NameDarifenacin
Generic NameDarifenacin
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2016-11-18
Marketing CategoryANDA / ANDA
Application NumberANDA205209
Labeler NameTorrent Pharmaceuticals Limited
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 13668-202-05

500 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-202-05)
Marketing Start Date2016-11-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 13668-202-90 [13668020290]

Darifenacin TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA205209
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-11-18

NDC 13668-202-74 [13668020274]

Darifenacin TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA205209
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-11-18

NDC 13668-202-30 [13668020230]

Darifenacin TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA205209
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-11-18

NDC 13668-202-05 [13668020205]

Darifenacin TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA205209
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-11-18

Drug Details

Active Ingredients

IngredientStrength
DARIFENACIN HYDROBROMIDE7.5 mg/1

OpenFDA Data

SPL SET ID:e84f1ae3-b9a2-4a15-a299-c75373891cc1
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 485423
  • 485421

    • Pharmacological Class

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

    Medicade Reported Pricing

    13668020290 DARIFENACIN ER 7.5 MG TABLET

    Pricing Unit: EA | Drug Type:

    13668020230 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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