Prescription drug · ANDA
Prasugrel NDC 65862-829
Prasugrel hydrochloride 5 mg/1 · Tablet, Film coated · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65862-829-03 | 65862082903 | 3 BLISTER PACK in 1 CARTON (65862-829-03) / 10 TABLET, FILM COATED in 1 BLISTER PACK (65862-829-10)Marketed from Oct 16, 2017 | |
| 65862-829-30 | 65862082930 | 30 TABLET, FILM COATED in 1 BOTTLE (65862-829-30)Marketed from Oct 16, 2017 |
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
- Labeler
- Aurobindo Pharma LimitedNDC labeler code 65862
- 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 65862-829_ad62076d-f75e-4cfa-b68f-3e873f244bcbSPL ID ad62076d-f75e-4cfa-b68f-3e873f244bcbSPL set ID 596c923d-db8d-4b96-bf31-52186a38c30dRxCUI 855812, 855818UNII G89JQ59I13UPC 0365862830302, 0365862829306
- 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
N465862082903followed by a unit qualifier and the quantityPackage 65862-0829-03. 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 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 65862-829
- What is NDC 65862-829?
- 65862-829 is the product NDC for Prasugrel, Prasugrel hydrochloride 5 mg/1 tablet, film coated, listed with the FDA by Aurobindo Pharma Limited. It has 2 package NDCs, 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?
- Aurobindo Pharma Limited, NDC labeler code 65862. 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 | American Health Packaging | 60687-883 | 60687-0883-21 |
| 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 |
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 | American Health Packaging | 60687-883 |
| Prasugrel | Prasugrel hydrochloride 10 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-4829 |
| Prasugrel | Prasugrel hydrochloride 10 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-830 |