NDC 0173-0822

Staxyn

Vardenafil Hydrochloride

Staxyn is a Oral Tablet, Orally Disintegrating in the Human Prescription Drug category. It is labeled and distributed by Glaxosmithkline Llc. The primary component is Vardenafil Hydrochloride.

• Product ID: 0173-0822_1a2c1fa7-6a5f-47e8-a487-1aa4a0e179b5
• NDC: 0173-0822
• Product Type: Human Prescription Drug
• Proprietary Name: Staxyn
• Generic Name: Vardenafil Hydrochloride
• Dosage Form: Tablet, Orally Disintegrating
• Route of Administration: ORAL
• Marketing Start Date: 2011-04-21
• Marketing Category: NDA / NDA
• Application Number: NDA200179
• Labeler Name: GlaxoSmithKline LLC
• Substance Name: VARDENAFIL HYDROCHLORIDE
• Active Ingredient Strength: 12 mg/1
• Pharm Classes: Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 0173-0822-04

1 BLISTER PACK in 1 BOX (0173-0822-04) > 4 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK

• Marketing Start Date: 2011-04-21
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0173-0822-04 [00173082204]

Staxyn TABLET, ORALLY DISINTEGRATING

• Marketing Category: NDA
• Application Number: NDA200179
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2011-04-21

NDC 0173-0822-61 [00173082261]

Staxyn TABLET, ORALLY DISINTEGRATING

• Marketing Category: NDA
• Application Number: NDA200179
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2011-04-21
• Marketing End Date: 2020-02-28

NDC 0173-0822-14 [00173082214]

Staxyn TABLET, ORALLY DISINTEGRATING

• Marketing Category: NDA
• Application Number: NDA200179
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2011-04-21
• Marketing End Date: 2019-01-24

Drug Details

Active Ingredients

Ingredient	Strength
VARDENAFIL HYDROCHLORIDE	11.85 mg/1

OpenFDA Data

• SPL SET ID: 0e5139d8-bf61-4f21-a36b-81b96b9b07d1
• Manufacturer:
  • GlaxoSmithKline LLC
• UNII:
  • 5M8S2CU0TS
• RxNorm Concept Unique ID - RxCUI:
  • 996179
  • 996183
• UPC Code:
  • 0301730822048

Pharmacological Class

• Phosphodiesterase 5 Inhibitor [EPC]
• Phosphodiesterase 5 Inhibitors [MoA]

NDC Crossover Matching brand name "Staxyn" or generic name "Vardenafil Hydrochloride"

NDC	Brand Name	Generic Name
0173-0822	Staxyn	vardenafil hydrochloride
0173-0829	Levitra	vardenafil hydrochloride
0173-0830	Levitra	vardenafil hydrochloride
0173-0831	Levitra	vardenafil hydrochloride
0093-7652	Vardenafil Hydrochloride	Vardenafil Hydrochloride
0093-7653	Vardenafil Hydrochloride	Vardenafil Hydrochloride
0093-7654	Vardenafil Hydrochloride	Vardenafil Hydrochloride
0093-7655	Vardenafil Hydrochloride	Vardenafil Hydrochloride
0527-2800	Vardenafil Hydrochloride	Vardenafil Hydrochloride
0527-2801	Vardenafil Hydrochloride	Vardenafil Hydrochloride
0527-2802	Vardenafil Hydrochloride	Vardenafil Hydrochloride
0527-2803	Vardenafil Hydrochloride	Vardenafil Hydrochloride