Prescription drug · ANDA
Prasugrel NDC 51407-444
Prasugrel hydrochloride 5 mg/1 · Tablet, Film coated · Oral · Golden State Medical Supply, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51407-444-30 | 51407044430 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51407-444-30)Marketed from Jan 20, 2021 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205927
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Platelet Aggregation (Physiologic effect)P2Y12 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 51407-444_20262c39-020c-b649-e063-6294a90a2d9fSPL ID 20262c39-020c-b649-e063-6294a90a2d9fSPL set ID bb78f952-69a5-1620-e053-2a95a90afe97RxCUI 855812, 855818UNII G89JQ59I13
- 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
N451407044430followed by a unit qualifier and the quantityPackage 51407-0444-30. 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 are 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 tablets are indicated to reduce the rate of thrombotic CV events (including stent thrombosis) in patients with acute coronary syndrome (ACS) who are to be managed with percutaneous coronary inte…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 205927
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 | Mylan Pharmaceuticals Inc. | 0378-5185 |
| Prasugrel | Prasugrel hydrochloride 10 mg/1 | Tablet, Film coatedOral | Mylan Pharmaceuticals Inc. | 0378-5186 |
| Prasugrel | Prasugrel hydrochloride 10 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 51407-445 |