Prescription drug · ANDA
Clopidogrel (clopidogrel bisulfate) NDC 0904-6467
Clopidogrel bisulfate 300 mg/1 · Tablet, Film coated · Oral · Major Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0904-6467-07 | 00904646707 | 30 BLISTER PACK in 1 CARTON (0904-6467-07) / 1 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Apr 6, 2015 | |
| 0904-6467-10 | 00904646710 | 20 BLISTER PACK in 1 CARTON (0904-6467-10) / 1 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Apr 6, 2015 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 bisulfate
- Active ingredients
- Clopidogrel bisulfate — 300 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Major Pharmaceuticals
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076274
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2C8 Inhibitors (Mechanism)Decreased Platelet Aggregation (Physiologic effect)P2Y12 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 0904-6467_188c5658-7bc2-4331-a794-a2194863953cSPL ID 188c5658-7bc2-4331-a794-a2194863953cSPL set ID 4cd07a3c-9673-4aa0-b76a-d79df2399ee1RxCUI 749196UNII 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
N400904646707followed by a unit qualifier and the quantityPackage 00904-6467-07. 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 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 has been shown to reduce the rate of myocardial infarction (MI) and stroke. ( 1.1 ) - For patients with ST-elevation myocardial infarction (STEMI), clopidogrel tablets has been shown to reduce the rate of MI and stroke. ( 1.1 ) • Recent MI, recent stroke, or established peripheral arterial disease. Clopidogrel tablets has been shown to reduce the rate of MI and stroke. ( 1.2 ) 1.1 Acute Coronary Syndrome (ACS) • Clopidogrel tablets are indicated to reduce the ra…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 076274
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 |
|---|---|---|---|---|
| Clopidogrelclopidogrel bisulfate | Clopidogrel bisulfate 75 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-527 |
| Clopidogrelclopidogrel bisulfate | Clopidogrel bisulfate 300 mg/1 | Tablet, Film coatedOral | Apotex Corp. | 60505-3532 |
| Clopidogrelclopidogrel bisulfate | Clopidogrel bisulfate 75 mg/1 | Tablet, Film coatedOral | American Health Packaging | 68084-536 |
| Clopidogrelclopidogrel bisulfate | Clopidogrel bisulfate 300 mg/1 | Tablet, Film coatedOral | American Health Packaging | 68084-752 |
| Clopidogrelclopidogrel bisulfate | Clopidogrel bisulfate 75 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-2149 |
| Clopidogrelclopidogrel bisulfate | Clopidogrel bisulfate 75 mg/1 | Tablet, Film coatedOral | Apotex Corp. | 60505-0253 |