NDC 0054-0395

Dutasteride

Dutasteride

Dutasteride is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by West-ward Pharmaceuticals Corp.. The primary component is Dutasteride.

Product ID0054-0395_6f137001-db0e-4fcb-913a-c4c8a9a602e1
NDC0054-0395
Product TypeHuman Prescription Drug
Proprietary NameDutasteride
Generic NameDutasteride
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2013-08-01
Marketing CategoryANDA / ANDA
Application NumberANDA202204
Labeler NameWest-Ward Pharmaceuticals Corp.
Substance NameDUTASTERIDE
Active Ingredient Strength1 mg/1
Pharm Classes5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0054-0395-13

30 CAPSULE in 1 BOTTLE (0054-0395-13)
Marketing Start Date2013-08-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0054-0395-13 [00054039513]

Dutasteride CAPSULE
Marketing CategoryANDA
Application NumberANDA202204
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-11-23
Marketing End Date2020-01-02

NDC 0054-0395-22 [00054039522]

Dutasteride CAPSULE
Marketing CategoryANDA
Application NumberANDA202204
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-11-23
Marketing End Date2020-01-02

Drug Details

Active Ingredients

IngredientStrength
DUTASTERIDE.5 mg/1

OpenFDA Data

SPL SET ID:c3759886-6d13-43c5-a35b-558368154d96
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 351172
  • UPC Code
  • 0300540395131
  • 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

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