NDC 0378-5005

Alfuzosin Hydrochloride

Alfuzosin

Alfuzosin Hydrochloride is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Alfuzosin Hydrochloride.

Product ID0378-5005_0cb40738-5a0d-456f-b8cb-3aa25159e520
NDC0378-5005
Product TypeHuman Prescription Drug
Proprietary NameAlfuzosin Hydrochloride
Generic NameAlfuzosin
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2011-08-09
Marketing End Date2019-10-31
Marketing CategoryANDA / ANDA
Application NumberANDA079014
Labeler NameMylan Pharmaceuticals Inc.
Substance NameALFUZOSIN HYDROCHLORIDE
Active Ingredient Strength10 mg/1
Pharm ClassesAdrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC]
NDC Exclude FlagN

Packaging

NDC 0378-5005-77

90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-5005-77)
Marketing Start Date2011-08-09
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-5005-77 [00378500577]

Alfuzosin Hydrochloride TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA079014
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-08-09
Marketing End Date2019-10-31

NDC 0378-5005-05 [00378500505]

Alfuzosin Hydrochloride TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA079014
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-08-09
Marketing End Date2014-06-30

Drug Details

Active Ingredients

IngredientStrength
ALFUZOSIN HYDROCHLORIDE10 mg/1

OpenFDA Data

SPL SET ID:be485a4c-aba3-43fa-9904-403595bc3f96
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 861132
  • Pharmacological Class

    • Adrenergic alpha-Antagonists [MoA]
    • alpha-Adrenergic Blocker [EPC]

    NDC Crossover Matching brand name "Alfuzosin Hydrochloride" or generic name "Alfuzosin"

    NDCBrand NameGeneric Name
    0378-5005Alfuzosin Hydrochloridealfuzosin
    0440-5000Alfuzosin hydrochlorideAlfuzosin hydrochloride
    13668-021ALFUZOSIN HYDROCHLORIDEALFUZOSIN HYDROCHLORIDE
    29300-155Alfuzosin hydrochlorideAlfuzosin hydrochloride
    31722-302Alfuzosin HydrochlorideAlfuzosin Hydrochloride
    33261-994Alfuzosin HydrochlorideAlfuzosin Hydrochloride
    42291-110Alfuzosin HydrochlorideAlfuzosin Hydrochloride
    43353-746Alfuzosin Hydrochloridealfuzosin
    43353-945Alfuzosin hydrochlorideAlfuzosin hydrochloride
    47335-956Alfuzosin HydrochlorideAlfuzosin Hydrochloride
    55648-738Alfuzosin HydrochlorideAlfuzosin Hydrochloride
    57237-114Alfuzosin HydrochlorideAlfuzosin Hydrochloride
    60505-2850Alfuzosin HydrochlorideAlfuzosin Hydrochloride
    61919-349ALFUZOSIN HYDROCHLORIDEALFUZOSIN HYDROCHLORIDE
    63629-2353Alfuzosin HydrochlorideAlfuzosin Hydrochloride
    63629-2354Alfuzosin HydrochlorideAlfuzosin Hydrochloride
    63629-7907Alfuzosin hydrochlorideAlfuzosin hydrochloride
    63629-9155Alfuzosin hydrochlorideAlfuzosin hydrochloride
    63629-9295Alfuzosin HydrochlorideAlfuzosin Hydrochloride
    64679-738Alfuzosin HydrochlorideAlfuzosin Hydrochloride
    65862-249Alfuzosin HydrochlorideAlfuzosin Hydrochloride
    69097-844Alfuzosin HydrochlorideAlfuzosin Hydrochloride
    70934-306Alfuzosin HydrochlorideAlfuzosin Hydrochloride
    70934-961Alfuzosin HydrochlorideAlfuzosin Hydrochloride
    76282-302Alfuzosin hydrochlorideAlfuzosin hydrochloride
    71335-1529Alfuzosin HydrochlorideAlfuzosin Hydrochloride

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