Vardenafil Hydrochloride
- Product NDC
- 62135-864
- 11-digit product format
- 621350864
- Labeler code
- 62135
- Product ID
- 62135-864_459d49f5-7be3-8f85-e063-6294a90a2064
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Vardenafil Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Chartwell RX, LLC
- Application
- ANDA209057
- Marketing category
- ANDA
- Marketing start
- 2018-10-31
- Substance
- VARDENAFIL HYDROCHLORIDE
- Active strength
- 2.5 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 | 2.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 5M8S2CU0TS |
| Rxcui | 402273 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 62135-864-30 | Vardenafil Hydrochloride | 30 in 1 BOTTLE | TABLET | 30 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62135-864 | VARDENAFIL HYDROCHLORIDE TABLET [CHARTWELL RX, LLC] | 1 | Current NDC, 1 package rows | 20240308_57a0c163-a5e8-4c6e-a4ea-114cb2668407.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 62135-864-30 | 62135086430 | 30 TABLET in 1 BOTTLE (62135-864-30) | 30 tablet | 2024-02-26 | No | No | Historical |