Sildenafil Citrate
- Product NDC
- 80425-0304
- 11-digit product format
- 804250304
- Labeler code
- 80425
- Product ID
- 80425-0304_1cea7dc1-3b83-0c92-e063-6394a90aec21
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sildenafil Citrate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Advanced Rx Pharmacy of Tennessee, LLC
- Application
- ANDA091479
- Marketing category
- ANDA
- Marketing start
- 2023-04-12
- 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 |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 80425-0304-1 | 80425030401 | 30 TABLET in 1 BOTTLE (80425-0304-1) | 30 tablet | 2023-04-12 | No | No | Historical |
| 80425-0304-2 | 80425030402 | 60 TABLET in 1 BOTTLE (80425-0304-2) | 60 tablet | 2023-04-12 | No | No | Historical |
| 80425-0304-3 | 80425030403 | 90 TABLET in 1 BOTTLE (80425-0304-3) | 90 tablet | 2023-04-12 | No | No | Historical |
| 80425-0304-4 | 80425030404 | 50 TABLET in 1 BOTTLE (80425-0304-4) | 50 tablet | 2024-07-10 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Sildenafil Tablets | Advanced Rx Pharmacy of Tennessee, LLC | 2024-07-10 | HUMAN PRESCRIPTION DRUG LABEL | 2 |