tadalafil
- Product NDC
- 50090-7314
- 11-digit product format
- 500907314
- Labeler code
- 50090
- Product ID
- 50090-7314_2176f66f-e44c-4ab4-9d78-85e95a353b84
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tadalafil
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA215556
- Marketing category
- ANDA
- Marketing start
- 2023-04-01
- 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 |
|---|
| 50090-7314-0 | 50090731400 | 90 TABLET, FILM COATED in 1 BOTTLE (50090-7314-0) | 2024-10-14 | No | No | Historical |
| 50090-7314-1 | 50090731401 | 30 TABLET, FILM COATED in 1 BOTTLE (50090-7314-1) | 2024-10-14 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| tadalafil | A-S Medication Solutions | 2024-10-16 | HUMAN PRESCRIPTION DRUG LABEL | 2 |