NDC 67544-512

Levitra

Vardenafil Hydrochloride

Levitra is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Aphena Pharma Solutions - Tennessee, Inc.. The primary component is Vardenafil Hydrochloride.

• Product ID: 67544-512_2f463f71-cfb1-4db3-a004-02b88ceae1ad
• NDC: 67544-512
• Product Type: Human Prescription Drug
• Proprietary Name: Levitra
• Generic Name: Vardenafil Hydrochloride
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2008-05-15
• Marketing Category: NDA / NDA
• Application Number: NDA021400
• Labeler Name: APHENA PHARMA SOLUTIONS - TENNESSEE, INC.
• Substance Name: VARDENAFIL HYDROCHLORIDE
• Active Ingredient Strength: 10 mg/1
• Pharm Classes: Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA]
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 67544-512-06

6 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (67544-512-06)

• Marketing Start Date: 2008-05-15
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 67544-512-52 [67544051252]

Levitra TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA021400
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2008-05-15
• Inactivation Date: 2019-11-13

NDC 67544-512-02 [67544051202]

Levitra TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA021400
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2008-05-15
• Inactivation Date: 2019-11-13

NDC 67544-512-06 [67544051206]

Levitra TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA021400
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2008-05-15
• Inactivation Date: 2019-11-13

NDC 67544-512-12 [67544051212]

Levitra TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA021400
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2008-05-15
• Inactivation Date: 2019-11-13

NDC 67544-512-04 [67544051204]

Levitra TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA021400
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2008-05-15
• Inactivation Date: 2019-11-13

Drug Details

Active Ingredients

Ingredient	Strength
VARDENAFIL HYDROCHLORIDE	10 mg/1

OpenFDA Data

• SPL SET ID: 34c30372-08b0-4060-8aba-779b5bc1e5dd
• Manufacturer:
  • APHENA PHARMA SOLUTIONS - TENNESSEE, INC.
• UNII:
  • 5M8S2CU0TS
• RxNorm Concept Unique ID - RxCUI:
  • 349479
  • 349480
  • 404639
  • 404638

Pharmacological Class

• 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