NDC 46708-224

DARIFENACIN

Darifenacin

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

Product ID46708-224_da7c2732-232c-4e71-92d9-577ef8617f56
NDC46708-224
Product TypeHuman Prescription Drug
Proprietary NameDARIFENACIN
Generic NameDarifenacin
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2017-12-12
Marketing CategoryANDA / ANDA
Application NumberANDA207681
Labeler NameAlembic Pharmaceuticals Limited
Substance NameDARIFENACIN HYDROBROMIDE
Active Ingredient Strength15 mg/1
Pharm ClassesCholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 46708-224-08

8 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (46708-224-08)
Marketing Start Date2017-12-12
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 46708-224-30 [46708022430]

DARIFENACIN TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA207681
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-12-12

NDC 46708-224-91 [46708022491]

DARIFENACIN TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA207681
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-12-12

NDC 46708-224-08 [46708022408]

DARIFENACIN TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA207681
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-12-12

NDC 46708-224-90 [46708022490]

DARIFENACIN TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA207681
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-12-12

Drug Details

Active Ingredients

IngredientStrength
DARIFENACIN HYDROBROMIDE15 mg/1

OpenFDA Data

SPL SET ID:da7c2732-232c-4e71-92d9-577ef8617f56
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 485423
  • 485421
    • UPC Code
  • 0346708223304
  • 0346708224301

    • Pharmacological Class

    • 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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