Prescription drug · ANDA
Prasugrel NDC 63629-4829
Prasugrel hydrochloride 10 mg/1 · Tablet, Film coated · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-4829-1 | 63629482901 | 30 TABLET, FILM COATED in 1 BOTTLE (63629-4829-1)Marketed from Nov 25, 2024 | |
| 63629-4829-2 | 63629482902 | 90 TABLET, FILM COATED in 1 BOTTLE (63629-4829-2)Marketed from Nov 25, 2024 |
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 — 10 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Bryant Ranch PrepackNDC labeler code 63629
- 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 63629-4829_9221d9d1-600c-4a0b-8234-bff051dfb4daSPL ID 9221d9d1-600c-4a0b-8234-bff051dfb4daSPL set ID 9c3994da-da45-43ce-9727-a842a43c5693RxCUI 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
N463629482901followed by a unit qualifier and the quantityPackage 63629-4829-01. 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 63629-4829
- What is NDC 63629-4829?
- 63629-4829 is the product NDC for Prasugrel, Prasugrel hydrochloride 10 mg/1 tablet, film coated, listed with the FDA by Bryant Ranch Prepack. 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?
- Bryant Ranch Prepack, NDC labeler code 63629. 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 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 |