NDC 70771-1356

Dutasteride and tamsulosin hydrochloride

Dutasteride And Tamsulosin Hydrochloride

Dutasteride and tamsulosin hydrochloride is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Zydus Lifesciences Limited. The primary component is Dutasteride; Tamsulosin Hydrochloride.

Product ID70771-1356_458221ba-8343-44fb-a46c-d75b1f67f403
NDC70771-1356
Product TypeHuman Prescription Drug
Proprietary NameDutasteride and tamsulosin hydrochloride
Generic NameDutasteride And Tamsulosin Hydrochloride
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2018-06-04
Marketing CategoryANDA / ANDA
Application NumberANDA207769
Labeler NameZydus Lifesciences Limited
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 70771-1356-3

30 CAPSULE in 1 BOTTLE (70771-1356-3)
Marketing Start Date2018-06-04
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70771-1356-9 [70771135609]

Dutasteride and tamsulosin hydrochloride CAPSULE
Marketing CategoryANDA
Application NumberANDA207769
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-06-04

NDC 70771-1356-3 [70771135603]

Dutasteride and tamsulosin hydrochloride CAPSULE
Marketing CategoryANDA
Application NumberANDA207769
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-06-04

Drug Details

Active Ingredients

IngredientStrength
DUTASTERIDE.5 mg/1

OpenFDA Data

SPL SET ID:4b89b07e-9d19-47a2-bd53-bc5eef9deed1
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]

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

    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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