NDC 0430-0170

Enablex

Darifenacin

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

Product ID0430-0170_130a7af0-15c9-478c-a8bb-938f608a0863
NDC0430-0170
Product TypeHuman Prescription Drug
Proprietary NameEnablex
Generic NameDarifenacin
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2004-12-22
Marketing CategoryNDA / NDA
Application NumberNDA021513
Labeler NameAllergan, 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 0430-0170-00

337500 TABLET, EXTENDED RELEASE in 1 DRUM (0430-0170-00)
Marketing Start Date2004-12-22
Marketing End Date2021-05-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0430-0170-15 [00430017015]

Enablex TABLET, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA021513
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2004-12-22

NDC 0430-0170-23 [00430017023]

Enablex TABLET, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA021513
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2004-12-22

NDC 0430-0170-00 [00430017000]

Enablex TABLET, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA021513
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2004-12-22

NDC 0430-0170-96 [00430017096]

Enablex TABLET, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA021513
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2004-12-22

NDC 0430-0170-95 [00430017095]

Enablex TABLET, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA021513
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2004-12-22
Marketing End Date2013-11-05

Drug Details

Active Ingredients

IngredientStrength
DARIFENACIN HYDROBROMIDE7.5 mg/1

OpenFDA Data

SPL SET ID:a712f252-16d9-47df-b2bf-6794228f3a88
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 485423
  • 543027
  • 485421
  • 543021

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    0430-0170Enablexdarifenacin
    0430-0171Enablexdarifenacin
    0591-4375Darifenacindarifenacin
    0591-4380Darifenacindarifenacin
    13668-202DarifenacinDarifenacin
    13668-203DarifenacinDarifenacin
    16571-767DarifenacinDarifenacin
    16571-768DarifenacinDarifenacin
    33342-276DarifenacinDarifenacin
    33342-277DarifenacinDarifenacin
    46708-223DARIFENACINDARIFENACIN
    46708-224DARIFENACINDARIFENACIN
    62332-223DARIFENACINDARIFENACIN
    62332-224DARIFENACINDARIFENACIN
    65862-861DarifenacinDarifenacin
    65862-862DarifenacinDarifenacin

    Trademark Results [Enablex]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ENABLEX
    ENABLEX
    87505086 not registered Live/Pending
    Industrial Laminates/Norplex Inc
    2017-06-26
    ENABLEX
    ENABLEX
    75724259 2713780 Live/Registered
    ALLERGAN PHARMACEUTICALS INTERNATIONAL LIMITED
    1999-06-08
    ENABLEX
    ENABLEX
    75334787 not registered Dead/Abandoned
    Pfizer Inc.
    1997-08-01
    ENABLEX
    ENABLEX
    74584824 not registered Dead/Abandoned
    Pfizer Inc.
    1994-10-12
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