Sildenafil
- Product NDC
- 53002-1719
- 11-digit product format
- 530021719
- Labeler code
- 53002
- Product ID
- 53002-1719_69623a01-204b-4806-8992-5712e5aa25ba
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sildenafil
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA078380
- Marketing category
- ANDA
- Marketing start
- 2013-05-31
- Marketing end
- 0000-00-00
- 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
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
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 | Marketing end | Sample | Exclude flag | Status |
|---|
| 53002-1719-3 | 53002171903 | 30 TABLET, FILM COATED in 1 BOTTLE (53002-1719-3) | 2018-10-01 | 0000-00-00 | No | No | Current |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Sildenafil | RPK Pharmaceuticals, Inc. | 2023-06-07 | HUMAN PRESCRIPTION DRUG LABEL | 5 |