Prescription drug · ANDA
Clopidogrel (clopidogrel bisulfate) NDC 71205-073
Clopidogrel bisulfate 75 mg/1 · Tablet, Film coated · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71205-073-30 | 71205007330 | 30 TABLET, FILM COATED in 1 BOTTLE (71205-073-30)Marketed from Jul 2, 2018 | |
| 71205-073-60 | 71205007360 | 60 TABLET, FILM COATED in 1 BOTTLE (71205-073-60)Marketed from Jul 2, 2018 | |
| 71205-073-90 | 71205007390 | 90 TABLET, FILM COATED in 1 BOTTLE (71205-073-90)Marketed from Jul 2, 2018 |
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 bisulfate
- 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 090540
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2C8 Inhibitors (Mechanism)Decreased Platelet Aggregation (Physiologic effect)P2Y12 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 71205-073_3d0c235a-ed00-4295-91a1-c0af34ff07a5SPL ID 3d0c235a-ed00-4295-91a1-c0af34ff07a5SPL set ID ec296eed-81d0-4c1e-bff4-431851899157RxCUI 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
N471205007330followed by a unit qualifier and the quantityPackage 71205-0073-30. 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 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 have been shown to reduce the rate of myocardial infarction (MI) and stroke. (1.1) - For patients with ST-elevation myocardial infarction (STEMI), clopidogrel tablets have been shown to reduce the rate of MI and stroke. (1.1) • Recent MI, recent stroke, or established peripheral arterial disease. Clopidogrel tablets have 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 rate …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 090540
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 | A-S Medication Solutions | 50090-5868 |
| Clopidogrelclopidogrel bisulfate | Clopidogrel bisulfate 75 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-357 |
| Clopidogrelclopidogrel bisulfate | Clopidogrel bisulfate 75 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-2082 |
| Clopidogrelclopidogrel bisulfate | Clopidogrel bisulfate 75 mg/1 | Tablet, Film coatedOral | Legacy Pharmaceutical Packaging, LLC | 68645-590 |
| Clopidogrelclopidogrel bisulfate | Clopidogrel bisulfate 75 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-3319 |
| Clopidogrelclopidogrel bisulfate | Clopidogrel bisulfate 75 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-0080 |
| Clopidogrelclopidogrel bisulfate | Clopidogrel bisulfate 75 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-4023 |
| Clopidogrelclopidogrel bisulfate | Clopidogrel bisulfate 75 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-469 |
| Clopidogrelclopidogrel bisulfate | Clopidogrel bisulfate 75 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-1898 |