Tadalafil
- Product NDC
- 68071-2553
- 11-digit product format
- 680712553
- Labeler code
- 68071
- Product ID
- 68071-2553_2dcc51e1-75df-27c3-e063-6394a90aac6f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tadalafil
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA209167
- Marketing category
- ANDA
- Marketing start
- 2019-03-27
- Substance
- TADALAFIL
- Active strength
- 20 mg/1
- Pharmacologic classes
- Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 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 |
|---|
| 68071-2553-3 | 68071255303 | 30 TABLET, FILM COATED in 1 BOTTLE (68071-2553-3) | 2021-10-25 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Tadalafil | NuCare Pharmaceuticals,Inc. | 2025-02-10 | HUMAN PRESCRIPTION DRUG LABEL | 3 |