Prasugrel is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Aurobindo Pharma Limited. The primary component is Prasugrel Hydrochloride.
| Product ID | 65862-829_11f1a8af-65b5-4626-848c-85aba91c98a5 |
| NDC | 65862-829 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Prasugrel |
| Generic Name | Prasugrel |
| Dosage Form | Tablet, Film Coated |
| Route of Administration | ORAL |
| Marketing Start Date | 2017-10-16 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA205888 |
| Labeler Name | Aurobindo Pharma Limited |
| Substance Name | PRASUGREL HYDROCHLORIDE |
| Active Ingredient Strength | 5 mg/1 |
| Pharm Classes | Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2021-12-31 |
| Marketing Start Date | 2017-10-16 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA205888 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2017-10-16 |
| Marketing Category | ANDA |
| Application Number | ANDA205888 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2017-10-16 |
| Marketing Category | ANDA |
| Application Number | ANDA205888 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2017-10-16 |
| Ingredient | Strength |
|---|---|
| PRASUGREL HYDROCHLORIDE | 5 mg/1 |
| SPL SET ID: | 596c923d-db8d-4b96-bf31-52186a38c30d |
| 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 |