NDC 68071-3380

Finasteride

Finasteride

Finasteride is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Nucare Pharmaceuticals,inc.. The primary component is Finasteride.

Product ID68071-3380_549aab5d-819b-1691-e054-00144ff88e88
NDC68071-3380
Product TypeHuman Prescription Drug
Proprietary NameFinasteride
Generic NameFinasteride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2010-05-28
Marketing CategoryANDA / ANDA
Application NumberANDA090121
Labeler NameNuCare Pharmaceuticals,Inc.
Substance NameFINASTERIDE
Active Ingredient Strength5 mg/1
Pharm Classes5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 68071-3380-3

30 TABLET, FILM COATED in 1 BOTTLE (68071-3380-3)
Marketing Start Date2017-07-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68071-3380-3 [68071338003]

Finasteride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090121
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-07-18

Drug Details

Active Ingredients

IngredientStrength
FINASTERIDE5 mg/1

OpenFDA Data

SPL SET ID:549aab5d-819a-1691-e054-00144ff88e88
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 310346
  • Pharmacological Class

    • 5-alpha Reductase Inhibitor [EPC]
    • 5-alpha Reductase Inhibitors [MoA]

    NDC Crossover Matching brand name "Finasteride" or generic name "Finasteride"

    NDCBrand NameGeneric Name
    0093-7355FinasterideFinasteride
    0179-0175FinasterideFinasteride
    0378-5036Finasteridefinasteride
    0904-6830FinasterideFinasteride
    16729-089FinasterideFinasteride
    16729-090Finasteridefinasteride
    17856-0090Finasteridefinasteride
    31722-525FinasterideFinasteride
    31722-526FinasterideFinasteride
    33261-833FinasterideFinasteride
    35573-400FinasterideFinasteride
    42291-280FinasterideFinasteride
    43598-303FinasterideFinasteride
    43598-390FinasterideFinasteride
    45963-500FinasterideFinasteride
    45963-600FINASTERIDEFINASTERIDE
    47335-714FinasterideFinasteride
    47335-715FINASTERIDEFINASTERIDE
    50090-1718Finasteridefinasteride
    67877-288FinasterideFinasteride
    67877-455FinasterideFinasteride
    68071-1648FinasterideFinasteride
    68071-1710FinasterideFinasteride
    68071-3234FinasterideFinasteride
    68071-3306FinasterideFinasteride
    68071-4044FinasterideFinasteride
    68071-3354FinasterideFinasteride
    68071-3380FinasterideFinasteride
    68071-4167FinasterideFinasteride
    68071-4541FinasterideFinasteride
    68071-4808FinasterideFinasteride
    68084-399FinasterideFinasteride
    68382-074FinasterideFinasteride
    68645-541FinasterideFinasteride
    68554-3026FinasterideFinasteride
    68554-3025FinasterideFinasteride
    68788-6976FinasterideFinasteride
    68788-6875FinasterideFinasteride
    68788-9519FinasterideFinasteride
    68788-9249FinasterideFinasteride
    68788-9517FinasterideFinasteride
    69097-112FinasterideFinasteride
    70518-0397FinasterideFinasteride
    70518-1704FinasterideFinasteride
    70771-1152FinasterideFinasteride
    71335-0433FinasterideFinasteride
    71335-0281FinasterideFinasteride
    71335-0235FinasterideFinasteride
    76282-412FinasterideFinasteride
    76519-1204FINASTERIDEFINASTERIDE

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.