Sildenafil
- Product NDC
- 68001-597
- 11-digit product format
- 680010597
- Labeler code
- 68001
- Product ID
- 68001-597_28da809a-99b6-e220-e063-6294a90ac8ae
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sildenafil
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- BluePoint Laboratories
- Application
- ANDA203814
- Marketing category
- ANDA
- Marketing start
- 2023-06-12
- Substance
- SILDENAFIL CITRATE
- Active strength
- 20 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
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| BW9B0ZE037 | SILDENAFIL CITRATE | 171599-83-0 | SILDENAFIL CITRATE |
| 3M7OB98Y7H | SILDENAFIL | 139755-83-2 | Sildenafil |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 68001-597-05 | 68001059705 | 90 TABLET, FILM COATED in 1 BOTTLE (68001-597-05) | 2023-06-12 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Sildenafil | American Health Packaging | 2025-11-20 | HUMAN PRESCRIPTION DRUG LABEL | 7 |
| Sildenafil | BluePoint Laboratories | Macleods Pharmaceuticals Limited | 2024-12-11 | HUMAN PRESCRIPTION DRUG LABEL | 10 |