NDC 43353-748
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 | 43353-748_95bf61f7-6238-4b01-b70e-df731b5f642b |
| NDC | 43353-748 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Levitra |
| Generic Name | Vardenafil Hydrochloride |
| Dosage Form | Tablet, Film Coated |
| Route of Administration | ORAL |
| Marketing Start Date | 2011-04-22 |
| Marketing Category | NDA / NDA |
| Application Number | NDA021400 |
| Labeler Name | APHENA PHARMA SOLUTIONS - TENNESSEE, INC. |
| Substance Name | VARDENAFIL HYDROCHLORIDE |
| Active Ingredient Strength | 20 mg/1 |
| Pharm Classes | Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] |
| NDC Exclude Flag | E |
| Listing Certified Through | 2017-12-31 |
Packaging
NDC 43353-748-06
6 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-748-06)
| Marketing Start Date | 2011-04-22 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 43353-748-02 [43353074802]
Levitra TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA021400 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2011-04-22 |
| Inactivation Date | 2019-11-13 |
NDC 43353-748-12 [43353074812]
Levitra TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA021400 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2011-04-22 |
| Inactivation Date | 2019-11-13 |
NDC 43353-748-04 [43353074804]
Levitra TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA021400 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2011-04-22 |
| Inactivation Date | 2019-11-13 |
NDC 43353-748-06 [43353074806]
Levitra TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA021400 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2011-04-22 |
| Inactivation Date | 2019-11-13 |
NDC 43353-748-79 [43353074879]
Levitra TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA021400 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2011-04-22 |
| Inactivation Date | 2019-11-13 |
NDC 43353-748-52 [43353074852]
Levitra TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA021400 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2011-04-22 |
| Inactivation Date | 2019-11-13 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| VARDENAFIL HYDROCHLORIDE | 20 mg/1 |
OpenFDA Data
| SPL SET ID: | 4e66ad5c-572c-4819-8b6e-6930c33cc210 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
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 |
Trademark Results [Levitra]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 LEVITRA 78560108 3050814 Live/Registered |
Bayer Aktiengesellschaft 2005-02-03 |
 LEVITRA 75913260 2622847 Live/Registered |
Bayer Aktiengesellschaft 2000-02-08 |
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