TADALAFIL
- Product NDC
- 68071-3753
- 11-digit product format
- 680713753
- Labeler code
- 68071
- Product ID
- 68071-3753_2a4622de-32d5-9071-e063-6294a90a87d7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- tadalafil
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA210609
- Marketing category
- ANDA
- Marketing start
- 2022-01-18
- 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 |
|---|
| 68071-3753-3 | 68071375303 | 30 TABLET in 1 BOTTLE (68071-3753-3) | 30 tablet | 2024-12-27 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| TADALAFIL | NuCare Pharmaceuticals,Inc. | NuCare Pharmaceuticals, Inc. | 2024-12-27 | HUMAN PRESCRIPTION DRUG LABEL | 1 |