PRASUGREL
- Product NDC
- 60505-4856
- 11-digit product format
- 605054856
- Labeler code
- 60505
- Product ID
- 60505-4856_4eed584a-92dd-f219-e063-6394a90a0dd0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PRASUGREL
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Apotex Corp.
- Application
- ANDA205897
- Marketing category
- ANDA
- Marketing start
- 2025-02-15
- Substance
- PRASUGREL HYDROCHLORIDE
- Active strength
- 10 mg/1
- Pharmacologic classes
- Decreased Platelet Aggregation [PE], P2Y12 Platelet Inhibitor [EPC], P2Y12 Receptor Antagonists [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 |
|---|
| G89JQ59I13 | PRASUGREL HYDROCHLORIDE | 389574-19-0 | PRASUGREL HYDROCHLORIDE |
| 34K66TBT99 | PRASUGREL | 150322-43-3 | PRASUGREL |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 60505-4856-3 | 60505485603 | 30 TABLET, FILM COATED in 1 BOTTLE (60505-4856-3) | 2025-02-15 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| PRASUGREL | Apotex Corp. | PANACEA BIOTEC PHARMA LIMITED | 2026-04-08 | HUMAN PRESCRIPTION DRUG LABEL | 9 |