tadalafil
- Product NDC
- 71205-754
- 11-digit product format
- 712050754
- Labeler code
- 71205
- Product ID
- 71205-754_ac93704f-8e33-43ba-8b56-3d61092ff1d9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- tadalafil
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA209250
- 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 | Marketing start | Sample | Exclude flag | Status |
|---|
| 71205-754-10 | 71205075410 | 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-754-10) | 2023-01-31 | No | No | Historical |
| 71205-754-20 | 71205075420 | 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-754-20) | 2023-01-31 | No | No | Historical |
| 71205-754-30 | 71205075430 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-754-30) | 2023-01-31 | No | No | Historical |
| 71205-754-60 | 71205075460 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-754-60) | 2023-01-31 | No | No | Historical |
| 71205-754-90 | 71205075490 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-754-90) | 2023-01-31 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| tadalafil | Proficient Rx LP | 2023-01-01 | HUMAN PRESCRIPTION DRUG LABEL | 1 |