Vardenafil
- Product NDC
- 46708-235
- 11-digit product format
- 467080235
- Labeler code
- 46708
- Product ID
- 46708-235_2ca8929b-0b62-4302-9ab4-60ad3768e803
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Vardenafil
- Dosage form
- TABLET, ORALLY DISINTEGRATING
- Route
- ORAL
- Labeler
- Alembic Pharmaceuticals Limited
- Application
- ANDA208324
- Marketing category
- ANDA
- Marketing start
- 2018-11-20
- Substance
- VARDENAFIL HYDROCHLORIDE TRIHYDRATE
- Active strength
- 10 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 | 10 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 |
|---|
| 46708-235-04 | Vardenafil | 4 in 1 BLISTER PACK | TABLET, ORALLY DISINTEGRATING | 4 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 46708-235 | VARDENAFIL TABLET, ORALLY DISINTEGRATING [ALEMBIC PHARMACEUTICALS LIMITED] | 3 | Current NDC, Legacy NDC, 1 package rows | 20230125_dce0b31b-4522-4cb4-9dba-3aea2b2bb082.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 46708-235-04 | 46708023504 | 4 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (46708-235-04) | 2018-11-20 | 0000-00-00 | No | No | Current |