tadalafil
- Product NDC
- 72789-344
- 11-digit product format
- 727890344
- Labeler code
- 72789
- Product ID
- 72789-344_40bb5cc5-f384-9589-e063-6394a90a4516
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tadalafil
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA215556
- Marketing category
- ANDA
- Marketing start
- 2023-04-01
- 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 |
|---|
| 72789-344-15 | 72789034415 | 15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-344-15) | 2023-08-07 | No | No | Historical |
| 72789-344-90 | 72789034490 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-344-90) | 2024-10-24 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| tadalafil | PD-Rx Pharmaceuticals, Inc. | 2025-10-09 | HUMAN PRESCRIPTION DRUG LABEL | 8 |
| tadalafil | PD-Rx Pharmaceuticals, Inc. | 2024-10-24 | HUMAN PRESCRIPTION DRUG LABEL | 7 |