Prescription drug · ANDA
Clopidogrel (clopidogrel bisulfate) NDC 69367-200
Clopidogrel bisulfate 75 mg/1 · Tablet, Film coated · Oral · Westminster Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69367-200-05 | 69367020005 | 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69367-200-05)Marketed from May 15, 2023 |
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
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204165
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2C8 Inhibitors (Mechanism)Decreased Platelet Aggregation (Physiologic effect)P2Y12 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 69367-200_175ba166-6dc4-41d9-a75e-853cb6d47aebSPL ID 175ba166-6dc4-41d9-a75e-853cb6d47aebSPL set ID bb3b5e96-e629-4db5-8ad5-40c17c6dae18RxCUI 309362, 749196UNII 08I79HTP27UPC 0369367194303
- 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
N469367020005followed by a unit qualifier and the quantityPackage 69367-0200-05. 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 is 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 has been shown to reduce the rate of myocardial infarction (MI) and stroke. ( 1.1 ) – For patients with ST-elevation myocardial infarction (STEMI), clopidogrel has been shown to reduce the rate of MI and stroke. ( 1.1 ) Recent MI, recent stroke, or established peripheral arterial disease. Clopidogrel has been shown to reduce the rate of MI and stroke. ( 1.2 ) 1.1 Acute Coronary Syndrome (ACS) Clopidogrel is indicated to reduce the rate of myocardial infarction (MI) and stroke in p…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 204165
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 bisulfate | Clopidogrel bisulfate 75 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-639 |
| Clopidogrelclopidogrel bisulfate | Clopidogrel bisulfate 300 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 82804-986 |
| Clopidogrel bisulfate | Clopidogrel bisulfate 300 mg/1 | Tablet, Film coatedOral | ScieGen Pharmaceuticals Inc | 50228-121 |
| Clopidogrel bisulfate | Clopidogrel bisulfate 75 mg/1 | Tablet, Film coatedOral | ScieGen Pharmaceuticals Inc | 50228-124 |
| Clopidogrel bisulfate | Clopidogrel bisulfate 75 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 72162-2212 |
| Clopidogrel bisulfate | Clopidogrel bisulfate 75 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8625 |
| Clopidogrel bisulfate | Clopidogrel bisulfate 75 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-5277 |
| Clopidogrel | Clopidogrel bisulfate 75 mg/1 | TabletOral | Vensun Pharmaceuticals, Inc. | 42543-713 |
| Clopidogrel | Clopidogrel bisulfate 300 mg/1 | TabletOral | Vensun Pharmaceuticals, Inc. | 42543-714 |
| Clopidogrel bisulfate | Clopidogrel bisulfate 75 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals, Inc. | 68788-7700 |
| Clopidogrel bisulfate | Clopidogrel bisulfate 75 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1646 |
| Clopidogrelclopidogrel bisulfate | Clopidogrel bisulfate 300 mg/1 | Tablet, Film coatedOral | AvPAK | 50268-184 |
| Clopidogrel bisulfate | Clopidogrel bisulfate 75 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4110 |
| Clopidogrelclopidogrel bisulfate | Clopidogrel bisulfate 300 mg/1 | Tablet, Film coatedOral | Westminster Pharmaceuticals, LLC | 69367-194 |
| Clopidogrel bisulfate | Clopidogrel bisulfate 75 mg/1 | Tablet, Film coatedOral | RADHA PHARMACEUTICALS, INC. | 77771-124 |
| Clopidogrel bisulfate | Clopidogrel bisulfate 300 mg/1 | Tablet, Film coatedOral | RADHA PHARMACEUTICALS, INC. | 77771-121 |