NDC 0591-4375

Darifenacin

Darifenacin

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

Product ID0591-4375_63338283-ed86-4dac-a4c5-50f75db9e220
NDC0591-4375
Product TypeHuman Prescription Drug
Proprietary NameDarifenacin
Generic NameDarifenacin
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2016-03-15
Marketing End Date2021-05-31
Marketing CategoryNDA / NDA
Application NumberNDA021513
Labeler NameActavis Pharma, Inc.
Substance NameDARIFENACIN HYDROBROMIDE
Active Ingredient Strength8 mg/1
Pharm ClassesCholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]
NDC Exclude FlagN

Packaging

NDC 0591-4375-30

30 TABLET, EXTENDED RELEASE in 1 BOTTLE (0591-4375-30)
Marketing Start Date2016-03-15
Marketing End Date2021-05-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0591-4375-30 [00591437530]

Darifenacin TABLET, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA021513
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-03-15

NDC 0591-4375-19 [00591437519]

Darifenacin TABLET, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA021513
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-03-15
Marketing End Date2019-07-31

Drug Details

Active Ingredients

IngredientStrength
DARIFENACIN HYDROBROMIDE7.5 mg/1

OpenFDA Data

SPL SET ID:71add478-b308-41c6-a1fd-40159b7be2fd
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 485423
  • 485421
    • UPC Code
  • 0305914375306
  • 0305914380300

    • Pharmacological Class

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

    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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