Vardenafil Hydrochloride
- Product NDC
- 42291-826
- 11-digit product format
- 422910826
- Labeler code
- 42291
- Product ID
- 42291-826_3b038d71-adaa-fc9a-e063-6294a90abe6a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Vardenafil Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- AvKARE
- Application
- ANDA209057
- Marketing category
- ANDA
- Marketing start
- 2025-07-28
- Substance
- VARDENAFIL HYDROCHLORIDE
- Active strength
- 5 mg/1
- Pharmacologic classes
- Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Vardenafil Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| VARDENAFIL HYDROCHLORIDE | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 5M8S2CU0TS |
| Rxcui | 349478 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 42291-826-30 | Vardenafil Hydrochloride | 30 in 1 BOTTLE | TABLET | 30 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 42291-826-30 | 42291082630 | 30 TABLET in 1 BOTTLE (42291-826-30) | 30 tablet | 2025-07-28 | No | No | Current |