Prescription drug · ANDA
Clopidogrel NDC 63187-362
Clopidogrel bisulfate 75 mg/1 · Tablet, Film coated · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63187-362-30 | 63187036230 | 30 TABLET, FILM COATED in 1 BOTTLE (63187-362-30)Marketed from Aug 1, 2016 | |
| 63187-362-60 | 63187036260 | 60 TABLET, FILM COATED in 1 BOTTLE (63187-362-60)Marketed from Aug 1, 2016 | |
| 63187-362-90 | 63187036290 | 90 TABLET, FILM COATED in 1 BOTTLE (63187-362-90)Marketed from Aug 1, 2016 |
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)
- Clopidogrel
- Generic name (nonproprietary)
- clopidogrel
- Active ingredients
- Clopidogrel bisulfate — 75 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Proficient Rx LP
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076999
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2C8 Inhibitors (Mechanism)Decreased Platelet Aggregation (Physiologic effect)P2Y12 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 63187-362_34f7e985-f275-4c4b-ab35-ffa37e49052bSPL ID 34f7e985-f275-4c4b-ab35-ffa37e49052bSPL set ID 25ed3120-7960-4e87-8422-de5c2026062cRxCUI 309362UNII 08I79HTP27
- 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
N463187036230followed by a unit qualifier and the quantityPackage 63187-0362-30. 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)
Clopidogrel tablets USP are a P2Y 12 platelet inhibitor indicated for: • Acute coronary syndrome • For patients with non-ST-segment elevation ACS [unstable angina (UA)/non-ST-elevation myocardial infarction (NSTEMI)], clopidogrel tablets USP have been shown to decrease the rate of a combined endpoint of cardiovascular death, myocardial infarction (MI), or stroke as well as the rate of a combined endpoint of cardiovascular death, MI, stroke, or refractory ischemia. ( 1.1 ) • For patients with ST-elevation myocardial infarction (STEMI), clopidogrel tablets USP have been shown to reduce the rate of death from any cause and the rate of a combined endpoint of death, re-infarction, or stroke. The …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 076999
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 |
|---|---|---|---|---|
| Clopidogrel | Clopidogrel bisulfate 75 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-4138 |
| Clopidogrel | Clopidogrel bisulfate 75 mg/1 | Tablet, Film coatedOral | Teva Pharmaceuticals USA, Inc. | 0093-7314 |