NDC 0591-2292

Dutasteride

Dutasteride

Dutasteride is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Actavis Pharma, Inc.. The primary component is Dutasteride.

Product ID0591-2292_8ab949b3-4db5-47f5-909c-dd0e6a34432c
NDC0591-2292
Product TypeHuman Prescription Drug
Proprietary NameDutasteride
Generic NameDutasteride
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2015-11-20
Marketing End Date2019-05-31
Marketing CategoryANDA / ANDA
Application NumberANDA202808
Labeler NameActavis Pharma, Inc.
Substance NameDUTASTERIDE
Active Ingredient Strength1 mg/1
Pharm Classes5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA]
NDC Exclude FlagN

Packaging

NDC 0591-2292-30

30 CAPSULE in 1 BOTTLE (0591-2292-30)
Marketing Start Date2015-11-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0591-2292-19 [00591229219]

Dutasteride CAPSULE
Marketing CategoryANDA
Application NumberANDA202808
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-11-20
Marketing End Date2019-05-31

NDC 0591-2292-30 [00591229230]

Dutasteride CAPSULE
Marketing CategoryANDA
Application NumberANDA202808
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-11-20
Marketing End Date2019-04-30

Drug Details

Active Ingredients

IngredientStrength
DUTASTERIDE.5 mg/1

OpenFDA Data

SPL SET ID:7502cc8b-b282-4454-94a2-f86302d54a47
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 351172
  • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    0054-0395DutasterideDutasteride
    0115-1438DutasterideDutasteride
    0591-2292DutasterideDutasteride
    25000-011DutasterideDutasteride
    31722-131DutasterideDutasteride
    42543-139DutasterideDutasteride
    42806-549DutasterideDutasteride
    50090-2285Dutasteridedutasteride
    50090-3040DutasterideDutasteride
    50090-4010DutasterideDutasteride
    50268-282DutasterideDutasteride
    51013-190DutasterideDutasteride
    51407-157DutasterideDutasteride
    51991-749DUTASTERIDEDUTASTERIDE
    53345-037DutasterideDutasteride
    60429-935Dutasteridedutasteride
    60505-3877Dutasteridedutasteride
    62112-8068Dutasteridedutasteride
    63187-657DutasterideDutasteride
    63629-1222DutasterideDutasteride
    63629-1223DutasterideDutasteride
    63629-8207DutasterideDutasteride
    64380-763DutasterideDutasteride
    64980-224DUTASTERIDEdutasteride
    68071-4237DutasterideDutasteride
    68071-4609DutasterideDutasteride
    68071-4607DutasterideDutasteride
    68071-4821DutasterideDutasteride
    68382-641DutasterideDutasteride
    70518-1966DutasterideDutasteride
    70771-1347DutasterideDutasteride
    71205-039DutasterideDutasteride
    65162-750DutasterideDutasteride
    72578-019DutasterideDutasteride
    71205-278DutasterideDutasteride
    70518-2256DutasterideDutasteride
    70518-2378DutasterideDutasteride
    72865-140DutasterideDutasteride
    0173-0712AVODARTdutasteride

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