tadalafil
- Product NDC
- 68071-3586
- 11-digit product format
- 680713586
- Labeler code
- 68071
- Product ID
- 68071-3586_13a1084b-7b8e-7866-e063-6394a90a3bba
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- tadalafil
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA209250
- Marketing category
- ANDA
- Marketing start
- 2019-03-26
- 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 |
|---|
| 68071-3586-9 | 68071358609 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68071-3586-9) | 2024-03-14 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| tadalafil | NuCare Pharmaceuticals,Inc. | 2024-03-14 | HUMAN PRESCRIPTION DRUG LABEL | 1 |