tadalafil
- Product NDC
- 82804-112
- 11-digit product format
- 828040112
- Labeler code
- 82804
- Product ID
- 82804-112_a080fd7b-7bde-40ad-ac8c-4c85453be8db
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- tadalafil
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA209250
- Marketing category
- ANDA
- Marketing start
- 2019-03-26
- 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 |
|---|
| 82804-112-10 | 82804011210 | 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-112-10) | 2024-07-18 | No | No | Historical |
| 82804-112-30 | 82804011230 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-112-30) | 2024-06-26 | No | No | Historical |
| 82804-112-90 | 82804011290 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-112-90) | 2024-06-17 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| tadalafil | Proficient Rx LP | 2024-08-01 | HUMAN PRESCRIPTION DRUG LABEL | 3 |