TADALAFIL
- Product NDC
- 70518-3931
- 11-digit product format
- 705183931
- Labeler code
- 70518
- Product ID
- 70518-3931_3bb16e3b-2b14-08fa-e063-6294a90a9090
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- tadalafil
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA210608
- Marketing category
- ANDA
- Marketing start
- 2023-12-04
- 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 |
|---|
| 70518-3931-0 | 70518393100 | 12 TABLET in 1 BOTTLE, PLASTIC (70518-3931-0) | 12 tablet | 2023-12-04 | No | No | Historical |
| 70518-3931-1 | 70518393101 | 90 TABLET in 1 BOTTLE, PLASTIC (70518-3931-1) | 90 tablet | 2023-12-07 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| TADALAFIL | REMEDYREPACK INC. | 2025-08-06 | HUMAN PRESCRIPTION DRUG LABEL | 4 |