Prescription drug · ANDA
Clopidogrel bisulfate NDC 43598-122
Clopidogrel bisulfate 300 mg/1 · Tablet, Film coated · Oral · Dr.Reddy's Laboratories Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43598-122-05 | 43598012205 | 500 TABLET, FILM COATED in 1 BOTTLE (43598-122-05)Marketed from Apr 15, 2025 | |
| 43598-122-30 | 43598012230 | 30 TABLET, FILM COATED in 1 BOTTLE (43598-122-30)Marketed from Apr 15, 2025 | |
| 43598-122-59 | 43598012259 | 5 BLISTER PACK in 1 CARTON (43598-122-59) / 6 TABLET, FILM COATED in 1 BLISTER PACK (43598-122-06)Marketed from Apr 15, 2025 |
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 bisulfate
- Generic name (nonproprietary)
- clopidogrel bisulfate
- Active ingredients
- Clopidogrel bisulfate — 300 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Dr.Reddy's Laboratories Inc
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091023
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2C8 Inhibitors (Mechanism)Decreased Platelet Aggregation (Physiologic effect)P2Y12 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 43598-122_76e9fa8d-c829-37b1-814e-844d436b7784SPL ID 76e9fa8d-c829-37b1-814e-844d436b7784SPL set ID 45caaa95-8470-b459-5f82-8156072d1878RxCUI 309362, 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
N443598012205followed by a unit qualifier and the quantityPackage 43598-0122-05. 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 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 o…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 091023
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 300 mg/1 | Tablet, Film coatedOral | McKesson Corporation dba SKY Packaging | 63739-178 |
| Clopidogrel bisulfate | Clopidogrel bisulfate 75 mg/1 | Tablet, Film coatedOral | Quallent Pharmaceuticals Health LLC | 82009-182 |
| Clopidogrel bisulfate | Clopidogrel bisulfate 75 mg/1 | Tablet, Film coatedOral | Dr.Reddy's Laboratories Inc | 43598-121 |
| Clopidogrel bisulfate | Clopidogrel bisulfate 300 mg/1 | Tablet, Film coatedOral | Dr.Reddy's Laboratories Limited | 55111-671 |
| Clopidogrel bisulfate | Clopidogrel bisulfate 75 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4680 |