Prescription drug · ANDA
Clopidogrel (clopidogrel bisulfate) NDC 71335-0080
Clopidogrel bisulfate 75 mg/1 · Tablet, Film coated · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-0080-1 | 71335008001 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-0080-1)Marketed from Apr 21, 2023 | |
| 71335-0080-2 | 71335008002 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-0080-2)Marketed from May 2, 2023 | |
| 71335-0080-3 | 71335008003 | 60 TABLET, FILM COATED in 1 BOTTLE (71335-0080-3)Marketed from May 29, 2024 | |
| 71335-0080-4 | 71335008004 | 20 TABLET, FILM COATED in 1 BOTTLE (71335-0080-4)Marketed from May 29, 2024 | |
| 71335-0080-5 | 71335008005 | 10 TABLET, FILM COATED in 1 BOTTLE (71335-0080-5)Marketed from May 29, 2024 |
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
- Generic name (nonproprietary)
- clopidogrel bisulfate
- Active ingredients
- Clopidogrel bisulfate — 75 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- 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 71335-0080_1de06f75-f138-4f1d-b71e-ad82b549d41bSPL ID 1de06f75-f138-4f1d-b71e-ad82b549d41bSPL set ID e8f98886-4771-4be3-8b57-edfbbc1b4661RxCUI 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
N471335008001followed by a unit qualifier and the quantityPackage 71335-0080-01. 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 of myo…
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 | Proficient Rx LP | 71205-073 |
| 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 | 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 |