VARDENAFIL HYDROCHLORIDE
- Product NDC
- 62332-238
- 11-digit product format
- 623320238
- Labeler code
- 62332
- Product ID
- 62332-238_fb17a719-cf8a-4d04-885a-3908378c5216
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- VARDENAFIL HYDROCHLORIDE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Alembic Pharmaceuticals Inc.
- Application
- ANDA214031
- Marketing category
- ANDA
- Marketing start
- 2020-08-05
- Substance
- VARDENAFIL HYDROCHLORIDE
- 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
openFDA Listing Details
- Product ID
- 62332-238_fb17a719-cf8a-4d04-885a-3908378c5216
- SPL ID
- fb17a719-cf8a-4d04-885a-3908378c5216
- Product type
- HUMAN PRESCRIPTION DRUG
- Finished product
- Yes
- Brand name base
- VARDENAFIL HYDROCHLORIDE
- Generic name
- VARDENAFIL HYDROCHLORIDE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing start
- 2020-08-05
- Marketing category
- ANDA
- Application number
- ANDA214031
- Pharmacologic classes
- Phosphodiesterase 5 Inhibitor [EPC]; Phosphodiesterase 5 Inhibitors [MoA]
- Listing expiration
- 2026-12-31
openFDA Active Ingredients
| Ingredient | Strength |
|---|
| VARDENAFIL HYDROCHLORIDE | 10 mg/1 |
openFDA Harmonized Identifiers
| Field | Values |
|---|
| Unii | 5M8S2CU0TS |
| Rxcui | 349478, 349479, 349480, 402273 |
| Spl Set Id | d2dce236-257e-44b6-93a9-9f0280257c6a |
| Manufacturer Name | Alembic Pharmaceuticals Inc. |
openFDA Package Details
| Package NDC | Description | Marketing start | Sample |
|---|
| 62332-238-30 | 30 TABLET, FILM COATED in 1 BOTTLE (62332-238-30) | 2020-08-05 | No |
| 62332-238-31 | 100 TABLET, FILM COATED in 1 BOTTLE (62332-238-31) | 2020-08-05 | No |
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 5M8S2CU0TS | VARDENAFIL HYDROCHLORIDE | 330808-88-3 | VARDENAFIL HYDROCHLORIDE |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 62332-238-30 | 62332023830 | 30 TABLET, FILM COATED in 1 BOTTLE (62332-238-30) | 2020-08-05 | No | No | Historical |
| 62332-238-31 | 62332023831 | 100 TABLET, FILM COATED in 1 BOTTLE (62332-238-31) | 2020-08-05 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| VARDENAFIL HYDROCHLORIDE | Alembic Pharmaceuticals Inc. | Alembic Pharmaceuticals Limited | 2023-03-22 | Human Prescription Drug Label | 8 |