NDC 0591-3771

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 Actavis Pharma, Inc.. The primary component is Dutasteride; Tamsulosin Hydrochloride.

• Product ID: 0591-3771_9cdbac0e-97f6-496c-885e-134a23bc3333
• NDC: 0591-3771
• Product Type: Human Prescription Drug
• Proprietary Name: Dutasteride and tamsulosin hydrochloride
• Generic Name: Dutasteride And Tamsulosin Hydrochloride
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 2016-04-13
• Marketing Category: ANDA / ANDA
• Application Number: ANDA202975
• Labeler Name: Actavis Pharma, Inc.
• Substance Name: DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE
• Active Ingredient Strength: 1 mg/1; mg/1
• Pharm Classes: 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA],Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0591-3771-30

30 CAPSULE in 1 BOTTLE (0591-3771-30)

• Marketing Start Date: 2016-04-13
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0591-3771-30 [00591377130]

Dutasteride and tamsulosin hydrochloride CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA202975
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-04-13

NDC 0591-3771-19 [00591377119]

Dutasteride and tamsulosin hydrochloride CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA202975
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-04-13

Drug Details

Active Ingredients

Ingredient	Strength
DUTASTERIDE	.5 mg/1

OpenFDA Data

• SPL SET ID: 4cfb1602-8046-4e6d-ae3a-78349b11fba8
• Manufacturer:
  • Actavis Pharma, Inc.
• UNII:
  • 11SV1951MR
  • O0J6XJN02I
• RxNorm Concept Unique ID - RxCUI:
  • 996097
• UPC Code:
  • 0305913771307

Pharmacological Class

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

NDC	Brand Name	Generic Name
0591-3771	Dutasteride and tamsulosin hydrochloride	Dutasteride and tamsulosin hydrochloride
10370-280	Dutasteride and Tamsulosin Hydrochloride	Dutasteride and Tamsulosin Hydrochloride Capsules
66993-580	Dutasteride and Tamsulosin Hydrochloride	dutasteride and tamsulosin hydrochloride
68382-640	Dutasteride and tamsulosin hydrochloride	Dutasteride and tamsulosin hydrochloride
70771-1356	Dutasteride and tamsulosin hydrochloride	Dutasteride and tamsulosin hydrochloride
0173-0809	JALYN	dutasteride and tamsulosin hydrochloride