NDC 10370-280

Dutasteride and Tamsulosin Hydrochloride

Dutasteride And Tamsulosin Hydrochloride Capsules

Dutasteride and Tamsulosin Hydrochloride is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Par Pharmaceutical, Inc.. The primary component is Dutasteride; Tamsulosin Hydrochloride.

Product ID10370-280_0c8988b2-50dc-4ae2-9e5b-cd7eed19521d
NDC10370-280
Product TypeHuman Prescription Drug
Proprietary NameDutasteride and Tamsulosin Hydrochloride
Generic NameDutasteride And Tamsulosin Hydrochloride Capsules
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2015-11-18
Marketing CategoryANDA / ANDA
Application NumberANDA202509
Labeler NamePar Pharmaceutical, Inc.
Substance NameDUTASTERIDE; TAMSULOSIN HYDROCHLORIDE
Active Ingredient Strength1 mg/1; mg/1
Pharm Classes5-alpha Reductase Inhibitor [EPC], 5-alpha Reductase Inhibitors [MoA], Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 10370-280-09

90 CAPSULE in 1 BOTTLE (10370-280-09)
Marketing Start Date2015-11-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 10370-280-09 [10370028009]

Dutasteride and Tamsulosin Hydrochloride CAPSULE
Marketing CategoryANDA
Application NumberANDA202509
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-11-18

NDC 10370-280-11 [10370028011]

Dutasteride and Tamsulosin Hydrochloride CAPSULE
Marketing CategoryANDA
Application NumberANDA202509
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-11-18

Drug Details

Active Ingredients

IngredientStrength
DUTASTERIDE.5 mg/1

OpenFDA Data

SPL SET ID:8c6031b3-b6a8-4ec7-b0d3-286f50d29353
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 996097

    • Pharmacological Class

    • 5-alpha Reductase Inhibitor [EPC]
    • 5-alpha Reductase Inhibitors [MoA]
    • Adrenergic alpha-Antagonists [MoA]
    • alpha-Adrenergic Blocker [EPC]

    Medicade Reported Pricing

    10370028011 DUTASTERIDE-TAMSULOSIN 0.5-0.4

    Pricing Unit: EA | Drug Type:

    10370028009 DUTASTERIDE-TAMSULOSIN 0.5-0.4

    Pricing Unit: EA | Drug Type:

    NDC Crossover Matching brand name "Dutasteride and Tamsulosin Hydrochloride" or generic name "Dutasteride And Tamsulosin Hydrochloride Capsules"

    NDCBrand NameGeneric Name
    0591-3771Dutasteride and tamsulosin hydrochlorideDutasteride and tamsulosin hydrochloride
    10370-280Dutasteride and Tamsulosin HydrochlorideDutasteride and Tamsulosin Hydrochloride Capsules
    66993-580Dutasteride and Tamsulosin Hydrochloridedutasteride and tamsulosin hydrochloride
    68382-640Dutasteride and tamsulosin hydrochlorideDutasteride and tamsulosin hydrochloride
    70771-1356Dutasteride and tamsulosin hydrochlorideDutasteride and tamsulosin hydrochloride
    0173-0809JALYNdutasteride and tamsulosin hydrochloride
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