Vardenafil
- Product NDC
- 33342-203
- 11-digit product format
- 333420203
- Labeler code
- 33342
- Product ID
- 33342-203_695d5a7e-546f-4e86-8edc-3c32e1d3bb19
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Vardenafil
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Macleods Pharmaceuticals Limited
- Application
- ANDA205988
- Marketing category
- ANDA
- Marketing start
- 2018-10-26
- Substance
- VARDENAFIL HYDROCHLORIDE TRIHYDRATE
- Active strength
- 11.85 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
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| VARDENAFIL HYDROCHLORIDE TRIHYDRATE | 11.85 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 5M8S2CU0TS |
| Rxcui | 996179 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 33342-203-37 | Vardenafil | 1 in 1 CARTON | TABLET | 1 | | 6 |
| 33342-203-37 | Vardenafil | 4 in 1 BLISTER PACK | TABLET | 4 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 33342-203 | VARDENAFIL TABLET [MACLEODS PHARMACEUTICALS LIMITED] | 6 | Current NDC, Legacy NDC, 2 package rows | 20250201_0ad213e0-d18a-4e67-a405-df95322eaa52.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 |
|---|
| 33342-203-37 | 33342020337 | 1 BLISTER PACK in 1 CARTON (33342-203-37) / 4 TABLET in 1 BLISTER PACK | 1 blister pack | 2018-10-26 | 0000-00-00 | No | No | Current |