NDC 55289-193

Levitra

Vardenafil Hydrochloride

Levitra is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Pd-rx Pharmaceuticals, In. The primary component is Vardenafil Hydr.

• Product ID: 55289-193_7abac133-8825-bd84-e053-2a91aa0a8e3c
• NDC: 55289-193
• Product Type: Human Prescription Drug
• Proprietary Name: Levitra
• Generic Name: Vardenafil Hydrochloride
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2003-08-25
• Marketing Category: NDA / NDA
• Application Number: NDA021400
• Labeler Name: PD-Rx Pharmaceuticals, In
• Substance Name: VARDENAFIL HYDR
• Active Ingredient Strength: 20 mg/1
• Pharm Classes: Phosphodiestera
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 55289-193-06

6 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-193-06)

• Marketing Start Date: 2011-01-22
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 55289-193-06 [55289019306]

Levitra TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA021400
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2011-01-22

Drug Details

Active Ingredients

Ingredient	Strength
VARDENAFIL HYDROCHLORIDE	20 mg/1

OpenFDA Data

• SPL SET ID: 8f935afa-f845-46cd-b61a-db7a48e559c0
• Manufacturer:
  • PD-Rx Pharmaceuticals, Inc.
• UNII:
  • 5M8S2CU0TS
• RxNorm Concept Unique ID - RxCUI:
  • 349480
  • 404639
• UPC Code:
  • 0355289193067

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
0173-0829	Levitra	vardenafil hydrochloride
0173-0830	Levitra	vardenafil hydrochloride
0173-0831	Levitra	vardenafil hydrochloride
43353-741	Levitra	Levitra
43353-748	Levitra	Levitra
43353-744	Levitra	Levitra
43353-323	Levitra	Levitra
55289-193	Levitra	Levitra
63629-3372	Levitra	Levitra
67544-507	Levitra	Levitra
67544-512	Levitra	Levitra
0173-0822	Staxyn	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