NDC 0173-0809

JALYN

Dutasteride And Tamsulosin Hydrochloride

JALYN is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Glaxosmithkline Llc. The primary component is Dutasteride; Tamsulosin Hydrochloride.

• Product ID: 0173-0809_731a1347-1e8d-41fe-b09f-9139e6ec2f76
• NDC: 0173-0809
• Product Type: Human Prescription Drug
• Proprietary Name: JALYN
• Generic Name: Dutasteride And Tamsulosin Hydrochloride
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 2010-06-21
• Marketing Category: NDA / NDA
• Application Number: NDA022460
• Labeler Name: GlaxoSmithKline LLC
• 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: 2022-12-31

Packaging

NDC 0173-0809-13

30 CAPSULE in 1 BOTTLE (0173-0809-13)

• Marketing Start Date: 2010-06-21
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0173-0809-61 [00173080961]

JALYN CAPSULE

• Marketing Category: NDA
• Application Number: NDA022460
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2010-06-21
• Marketing End Date: 2016-01-31

NDC 0173-0809-59 [00173080959]

JALYN CAPSULE

• Marketing Category: NDA
• Application Number: NDA022460
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2010-06-21

NDC 0173-0809-13 [00173080913]

JALYN CAPSULE

• Marketing Category: NDA
• Application Number: NDA022460
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2010-06-21

Drug Details

Active Ingredients

Ingredient	Strength
DUTASTERIDE	.5 mg/1

OpenFDA Data

• SPL SET ID: eba8376d-10e0-42fc-9f76-9e7ebf7ff047
• Manufacturer:
  • GlaxoSmithKline LLC
• UNII:
  • 11SV1951MR
  • O0J6XJN02I
• RxNorm Concept Unique ID - RxCUI:
  • 996097
  • 996101
• UPC Code:
  • 0301730809131

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 "JALYN" or generic name "Dutasteride And Tamsulosin Hydrochloride"

NDC	Brand Name	Generic Name
0173-0809	JALYN	dutasteride and tamsulosin hydrochloride
0591-3771	Dutasteride and tamsulosin hydrochloride	Dutasteride and tamsulosin hydrochloride
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