tadalafil
- Product NDC
- 68788-4083
- 11-digit product format
- 687884083
- Labeler code
- 68788
- Product ID
- 68788-4083_fee8c2be-ccfa-4c66-abed-5e232ec762ae
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- tadalafil
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA209250
- Marketing category
- ANDA
- Marketing start
- 2026-02-27
- Substance
- TADALAFIL
- Active strength
- 20 mg/1
- Pharmacologic classes
- Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- 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 |
|---|
| 68788-4083-1 | 68788408301 | 15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-4083-1) | 2026-02-27 | No | No | Historical |
| 68788-4083-3 | 68788408303 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-4083-3) | 2026-02-27 | No | No | Historical |
| 68788-4083-7 | 68788408307 | 7 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-4083-7) | 2026-02-27 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| tadalafil | Preferred Pharmaceuticals Inc. | 2026-02-27 | HUMAN PRESCRIPTION DRUG LABEL | 1 |