TADALAFIL
- Product NDC
- 71610-909
- 11-digit product format
- 716100909
- Labeler code
- 71610
- Product ID
- 71610-909_4db30371-c0ff-29b9-e063-6294a90ad6ff
- 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
- 2024-11-27
- Substance
- TADALAFIL
- Active strength
- 5 mg/1
- Pharmacologic classes
- Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- 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 |
|---|
| 71610-909-26 | 71610090926 | 1200 TABLET in 1 BOTTLE (71610-909-26) | 1200 tablet | 2025-11-07 | No | No | Historical |
| 71610-909-36 | 71610090936 | 2940 TABLET in 1 BOTTLE (71610-909-36) | 2940 tablet | 2025-05-13 | No | No | Historical |
| 71610-909-60 | 71610090960 | 90 TABLET in 1 BOTTLE (71610-909-60) | 90 tablet | 2026-03-19 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| TADALAFIL | Aphena Pharma Solutions - Tennessee, LLC | 2026-03-23 | HUMAN PRESCRIPTION DRUG LABEL | 3 |
| TADALAFIL | Aphena Pharma Solutions - Tennessee, LLC | 2025-05-14 | HUMAN PRESCRIPTION DRUG LABEL | 1 |