Prescription drug · ANDA
Prasugrel NDC 60505-4642
Prasugrel hydrochloride 5 mg/1 · Tablet, Film coated · Oral · Apotex Corp.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60505-4642-3 | 60505464203 | 30 TABLET, FILM COATED in 1 BOTTLE (60505-4642-3)Marketed from Oct 16, 2017 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Prasugrel
- Generic name (nonproprietary)
- prasugrel
- Active ingredients
- Prasugrel hydrochloride — 5 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Apotex Corp.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205897
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Platelet Aggregation (Physiologic effect)P2Y12 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 60505-4642_4eed584a-92dd-f219-e063-6394a90a0dd0SPL ID 4eed584a-92dd-f219-e063-6394a90a0dd0SPL set ID f51e64e0-f556-65d0-a876-fb709aaeefeaRxCUI 855812, 855818UNII G89JQ59I13UPC 0360505485635, 0360505464333, 0360505464234
- Pharmacologic class
- P2Y12 Platelet Inhibitor
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N460505464203followed by a unit qualifier and the quantityPackage 60505-4642-03. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
Prasugrel tablets is a P2Y 12 platelet inhibitor indicated for the reduction of thrombotic cardiovascular events (including stent thrombosis) in patients with acute coronary syndrome who are to be managed with percutaneous coronary intervention (PCI) as follows: Patients with unstable angina or non-ST-elevation myocardial infarction (NSTEMI) ( 1.1 ). Patients with ST-elevation myocardial infarction (STEMI) when managed with either primary or delayed PCI ( 1.1 ). 1.1 Acute Coronary Syndrome Prasugrel tablet is indicated to reduce the rate of thrombotic cardiovascular (CV) events (including stent thrombosis) in patients with acute coronary syndrome (ACS) who are to be managed with percutaneous…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 205897
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Prasugrel | Prasugrel hydrochloride 5 mg/1 | Tablet, Film coatedOral | Panacea Biotec Limited | 43817-239 |
| Prasugrel | Prasugrel hydrochloride 10 mg/1 | Tablet, Film coatedOral | Panacea Biotec Limited | 43817-240 |
| Prasugrel | Prasugrel hydrochloride 10 mg/1 | Tablet, Film coatedOral | Apotex Corp. | 60505-4643 |
| Prasugrel | Prasugrel hydrochloride 10 mg/1 | Tablet, Film coatedOral | Apotex Corp. | 60505-4856 |