Levitra
- Product NDC
- 43353-323
- 11-digit product format
- 433530323
- Labeler code
- 43353
- Product ID
- 43353-323_741bda18-742a-4192-b37c-41680ca38343
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- vardenafil hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- APHENA PHARMA SOLUTIONS - TENNESSEE, INC.
- Application
- NDA021400
- Marketing category
- NDA
- Marketing start
- 2008-05-15
- Marketing end
- 0000-00-00
- Substance
- VARDENAFIL HYDROCHLORIDE
- Active strength
- 5 mg/1
- Pharmacologic classes
- Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43353-323-02 | Levitra | 2 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 2 | | 1 |
| 43353-323-06 | Levitra | 6 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 6 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| VARDENAFIL HYDROCHLORIDE | ACTIVE INGREDIENT | 5M8S2CU0TS | LEVITRA (VARDENAFIL HYDROCHLORIDE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] | 1 | |
| VARDENAFIL | ACTIVE MOIETY | UCE6F4125H | LEVITRA (VARDENAFIL HYDROCHLORIDE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | LEVITRA (VARDENAFIL HYDROCHLORIDE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] | 1 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | LEVITRA (VARDENAFIL HYDROCHLORIDE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] | 1 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | LEVITRA (VARDENAFIL HYDROCHLORIDE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] | 1 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | LEVITRA (VARDENAFIL HYDROCHLORIDE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | LEVITRA (VARDENAFIL HYDROCHLORIDE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | LEVITRA (VARDENAFIL HYDROCHLORIDE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] | 1 | |
| POLYETHYLENE GLYCOL | INACTIVE INGREDIENT | 3WJQ0SDW1A | LEVITRA (VARDENAFIL HYDROCHLORIDE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | LEVITRA (VARDENAFIL HYDROCHLORIDE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | LEVITRA (VARDENAFIL HYDROCHLORIDE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43353-323 | LEVITRA (VARDENAFIL HYDROCHLORIDE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] | 1 | Legacy NDC, 2 package rows | 20111027_be38b325-3a6f-4569-9ae0-a03feff8535d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 43353-323-02 | 43353032302 | 2 in 1 BOTTLE, PLASTIC | Historical |
| 43353-323-06 | 43353032306 | 6 in 1 BOTTLE, PLASTIC | Historical |