Prescription drug · ANDA
Prasugrel NDC 60687-883
Prasugrel hydrochloride 10 mg/1 · Tablet, Film coated · Oral · American Health Packaging
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60687-883-21 | 60687088321 | 30 BLISTER PACK in 1 CARTON (60687-883-21) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-883-11)Marketed from Mar 2, 2025 |
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 — 10 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- American Health PackagingNDC labeler code 60687
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205888
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Platelet Aggregation (Physiologic effect)P2Y12 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 60687-883_2ddfdce2-a7ba-b612-e063-6294a90a0ce3SPL ID 2ddfdce2-a7ba-b612-e063-6294a90a0ce3SPL set ID 35aa7f3e-bbd8-4eae-b61f-29d1abca2224RxCUI 855812UNII 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
N460687088321followed by a unit qualifier and the quantityPackage 60687-0883-21. 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 interv…
Excerpt only. Read the full label for complete information.
About NDC 60687-883
- What is NDC 60687-883?
- 60687-883 is the product NDC for Prasugrel, Prasugrel hydrochloride 10 mg/1 tablet, film coated, listed with the FDA by American Health Packaging. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Prasugrel.
- What is the active ingredient?
- Prasugrel hydrochloride.
- Who is the labeler?
- American Health Packaging, NDC labeler code 60687. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Prasugrel?
- 18 other product NDCs are listed under this name. See all Prasugrel NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Prasugrel products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Prasugrel | Prasugrel hydrochloride 10 mg/1 | Tablet, Film coatedOral | Apotex Corp. | 60505-4856 | 60505-4856-03 |
| Prasugrel | Prasugrel hydrochloride 5 mg/1 | Tablet, Film coatedOral | Unichem Pharmaceuticals (USA), Inc. | 29300-301 | 29300-0301-13 |
| Prasugrel | Prasugrel hydrochloride 10 mg/1 | Tablet, Film coatedOral | Unichem Pharmaceuticals (USA), Inc. | 29300-302 | 29300-0302-13 |
| Prasugrel | Prasugrel hydrochloride 5 mg/1 | Tablet, Film coatedOral | Accord Healthcare Inc. | 16729-272 | 16729-0272-10 |
| Prasugrel | Prasugrel hydrochloride 10 mg/1 | Tablet, Film coatedOral | Accord Healthcare Inc. | 16729-273 | 16729-0273-10 |
| Prasugrel | Prasugrel hydrochloride 5 mg/1 | Tablet, Film coatedOral | Amneal Pharmaceuticals LLC | 65162-001 | 65162-0001-03 |
| Prasugrel | Prasugrel hydrochloride 10 mg/1 | Tablet, Film coatedOral | Amneal Pharmaceuticals LLC | 65162-002 | 65162-0002-03 |
| Prasugrel | Prasugrel hydrochloride 5 mg/1 | Tablet, Film coatedOral | Panacea Biotec Limited | 43817-239 | 43817-0239-01 |
| Prasugrel | Prasugrel hydrochloride 10 mg/1 | Tablet, Film coatedOral | Panacea Biotec Limited | 43817-240 | 43817-0240-01 |
| Prasugrel | Prasugrel hydrochloride 5 mg/1 | Tablet, Film coatedOral | Apotex Corp. | 60505-4642 | 60505-4642-03 |
Other NDCs under ANDA 205888
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 10 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-4829 |
| Prasugrel | Prasugrel hydrochloride 5 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-829 |
| Prasugrel | Prasugrel hydrochloride 10 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-830 |