Sildenafil Citrate
- Product NDC
- 68071-3549
- 11-digit product format
- 680713549
- Labeler code
- 68071
- Product ID
- 68071-3549_1884bfe6-392b-09dd-e063-6394a90aad46
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sildenafil
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA206401
- Marketing category
- ANDA
- Marketing start
- 2018-10-12
- Substance
- SILDENAFIL CITRATE
- Active strength
- 100 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 |
|---|
| 68071-3549-1 | 68071354901 | 10 TABLET, FILM COATED in 1 BOTTLE (68071-3549-1) | 2024-05-15 | No | No | Historical |
| 68071-3549-5 | 68071354905 | 15 TABLET, FILM COATED in 1 BOTTLE (68071-3549-5) | 2023-12-04 | No | No | Historical |
| 68071-3549-6 | 68071354906 | 60 TABLET, FILM COATED in 1 BOTTLE (68071-3549-6) | 2023-12-04 | No | No | Historical |
| 68071-3549-9 | 68071354909 | 90 TABLET, FILM COATED in 1 BOTTLE (68071-3549-9) | 2024-04-09 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Sildenafil Citrate | NuCare Pharmaceuticals,Inc. | 2024-05-15 | HUMAN PRESCRIPTION DRUG LABEL | 4 |