TADALAFIL
- Product NDC
- 71610-903
- 11-digit product format
- 716100903
- Labeler code
- 71610
- Product ID
- 71610-903_351dae30-b57e-b988-e063-6394a90a47f2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- tadalafil
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA210609
- Marketing category
- ANDA
- Marketing start
- 2022-01-18
- Substance
- TADALAFIL
- 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 |
|---|
| 742SXX0ICT | TADALAFIL | 171596-29-5 | TADALAFIL |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 71610-903-04 | 71610090304 | 4 TABLET in 1 BOTTLE (71610-903-04) | 4 tablet | 2025-05-01 | No | No | Historical |
| 71610-903-12 | 71610090312 | 12 TABLET in 1 BOTTLE (71610-903-12) | 12 tablet | 2025-05-01 | No | No | Historical |
| 71610-903-31 | 71610090331 | 600 TABLET in 1 BOTTLE (71610-903-31) | 600 tablet | 2025-05-13 | No | No | Historical |
| 71610-903-52 | 71610090352 | 18 TABLET in 1 BOTTLE (71610-903-52) | 18 tablet | 2025-05-01 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| TADALAFIL | Aphena Pharma Solutions - Tennessee, LLC | 2025-05-14 | HUMAN PRESCRIPTION DRUG LABEL | 2 |