Tadalafil
- Product NDC
- 71610-461
- 11-digit product format
- 716100461
- Labeler code
- 71610
- Product ID
- 71610-461_b5c51223-f994-41aa-8478-ed13dc51a908
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tadalafil
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA209654
- Marketing category
- ANDA
- Marketing start
- 2019-03-26
- Substance
- TADALAFIL
- Active strength
- 5 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 |
|---|
| 71610-461-08 | 71610046108 | 8 TABLET in 1 BOTTLE (71610-461-08) | 8 tablet | 2020-09-04 | No | No | Historical |
| 71610-461-11 | 71610046111 | 48 TABLET in 1 BOTTLE (71610-461-11) | 48 tablet | 2020-09-04 | No | No | Historical |
| 71610-461-23 | 71610046123 | 16 TABLET in 1 BOTTLE (71610-461-23) | 16 tablet | 2020-09-04 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Tadalafil | Aphena Pharma Solutions - Tennessee, LLC | 2020-10-02 | Human Prescription Drug Label | 1 |