Prasugrel is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Accord Healthcare Inc.. The primary component is Prasugrel Hydrochloride.
| Product ID | 16729-273_6bd723cb-61ae-1363-e053-2991aa0a38e6 |
| NDC | 16729-273 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Prasugrel |
| Generic Name | Prasugrel |
| Dosage Form | Tablet, Film Coated |
| Route of Administration | ORAL |
| Marketing Start Date | 2019-01-16 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA205987 |
| Labeler Name | Accord Healthcare Inc. |
| Substance Name | PRASUGREL HYDROCHLORIDE |
| Active Ingredient Strength | 10 mg/1 |
| Pharm Classes | Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2020-12-31 |
| Marketing Start Date | 2019-01-16 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA205987 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2019-01-16 |
| Ingredient | Strength |
|---|---|
| PRASUGREL HYDROCHLORIDE | 10 mg/1 |
| SPL SET ID: | cd6bf899-06b7-4f52-96c5-ffc94a7288ff |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0378-5185 | Prasugrel | Prasugrel |
| 0378-5186 | Prasugrel | Prasugrel |
| 0440-0604 | PRASUGREL | Prasugrel |
| 0440-0605 | PRASUGREL | Prasugrel |
| 16729-272 | Prasugrel | Prasugrel |
| 16729-273 | Prasugrel | Prasugrel |
| 43817-239 | Prasugrel | Prasugrel |
| 43817-240 | Prasugrel | Prasugrel |
| 48792-7821 | prasugrel | Prasugrel hydrochloride |
| 48792-7822 | prasugrel | Prasugrel hydrochloride |
| 50090-4118 | Prasugrel | Prasugrel |
| 50090-5169 | Prasugrel | Prasugrel |
| 51407-247 | Prasugrel | Prasugrel |
| 51407-248 | Prasugrel | Prasugrel |
| 51407-444 | Prasugrel | Prasugrel |
| 51407-445 | Prasugrel | Prasugrel |
| 60505-4642 | Prasugrel | Prasugrel |
| 60505-4643 | Prasugrel | Prasugrel |
| 60687-412 | Prasugrel | Prasugrel |
| 67877-604 | PRASUGREL | PRASUGREL |
| 67877-605 | PRASUGREL | PRASUGREL |
| 65162-001 | Prasugrel | Prasugrel |
| 65162-002 | Prasugrel | Prasugrel |
| 65862-829 | Prasugrel | Prasugrel |
| 65862-830 | Prasugrel | Prasugrel |