tadalafil
- Product NDC
- 71335-2583
- 11-digit product format
- 713352583
- Labeler code
- 71335
- Product ID
- 71335-2583_43a31ce4-0db9-417a-a1d9-80927c92a4cd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- tadalafil
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA209250
- Marketing category
- ANDA
- Marketing start
- 2019-03-26
- 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 | Marketing start | Sample | Exclude flag | Status |
|---|
| 71335-2583-1 | 71335258301 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-2583-1) | 2025-04-03 | No | No | Historical |
| 71335-2583-2 | 71335258302 | 10 TABLET, FILM COATED in 1 BOTTLE (71335-2583-2) | 2025-04-03 | No | No | Historical |
| 71335-2583-3 | 71335258303 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-2583-3) | 2025-04-03 | No | No | Historical |
| 71335-2583-4 | 71335258304 | 5 TABLET, FILM COATED in 1 BOTTLE (71335-2583-4) | 2025-04-03 | No | No | Historical |
| 71335-2583-5 | 71335258305 | 60 TABLET, FILM COATED in 1 BOTTLE (71335-2583-5) | 2025-04-03 | No | No | Historical |
| 71335-2583-6 | 71335258306 | 20 TABLET, FILM COATED in 1 BOTTLE (71335-2583-6) | 2025-04-03 | No | No | Historical |
| 71335-2583-7 | 71335258307 | 15 TABLET, FILM COATED in 1 BOTTLE (71335-2583-7) | 2025-04-03 | No | No | Historical |
| 71335-2583-8 | 71335258308 | 100 TABLET, FILM COATED in 1 BOTTLE (71335-2583-8) | 2025-04-03 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| tadalafil | Bryant Ranch Prepack | 2025-04-03 | HUMAN PRESCRIPTION DRUG LABEL | 1 |