Prescription drug · ANDA
Clopidogrel bisulfate NDC 68071-5277
Clopidogrel bisulfate 75 mg/1 · Tablet, Film coated · Oral · NuCare Pharmaceuticals,Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68071-5277-9 | 68071527709 | 90 TABLET, FILM COATED in 1 BOTTLE (68071-5277-9)Marketed from Jun 10, 2020 |
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)
- Clopidogrel bisulfate
- Generic name (nonproprietary)
- clopidogrel bisulfate
- Active ingredients
- Clopidogrel bisulfate — 75 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- NuCare Pharmaceuticals,Inc.
- 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 68071-5277_1d7904db-ccb2-b88e-e063-6294a90ac568SPL ID 1d7904db-ccb2-b88e-e063-6294a90ac568SPL set ID a7bf847d-43e9-166e-e053-2995a90a239eRxCUI 309362UNII 08I79HTP27UPC 0368071527797
- 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
N468071527709followed by a unit qualifier and the quantityPackage 68071-5277-09. 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 pat…
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 | 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 75 mg/1 | Tablet, Film coatedOral | Westminster Pharmaceuticals, LLC | 69367-200 |
| 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 |