Vardenafil Hydrochloride
- Product NDC
- 42291-848
- 11-digit product format
- 422910848
- Labeler code
- 42291
- Product ID
- 42291-848_4875c23d-91ea-f449-e063-6394a90a5a74
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Vardenafil Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- AvKARE
- Application
- ANDA209057
- Marketing category
- ANDA
- Marketing start
- 2019-01-31
- Substance
- VARDENAFIL HYDROCHLORIDE
- Active strength
- 20 mg/1
- Pharmacologic classes
- Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Vardenafil Hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| VARDENAFIL HYDROCHLORIDE | 20 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 5M8S2CU0TS |
| Rxcui | 349479, 349480 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 42291-848-30 | Vardenafil Hydrochloride | 30 in 1 BOTTLE | TABLET | 30 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42291-848 | VARDENAFIL HYDROCHLORIDE TABLET [AVKARE] | 4 | Current NDC, Legacy NDC, 1 package rows | 20240111_80c4793d-e19e-10f0-e053-2991aa0a4620.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 42291-848-30 | 42291084830 | 30 TABLET in 1 BOTTLE (42291-848-30) | 30 tablet | 2019-01-31 | 0000-00-00 | No | No | Current |