Prescription drug · ANDA
Warfarin Sodium (warfarin) NDC 68788-8402
Warfarin sodium 2.5 mg/1 · Tablet · Oral · Preferred Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68788-8402-1 | 68788840201 | 100 TABLET in 1 BOTTLE (68788-8402-1)Marketed from Mar 21, 2023 | |
| 68788-8402-3 | 68788840203 | 30 TABLET in 1 BOTTLE (68788-8402-3)Marketed from Mar 21, 2023 | |
| 68788-8402-6 | 68788840206 | 60 TABLET in 1 BOTTLE (68788-8402-6)Marketed from Mar 21, 2023 | |
| 68788-8402-9 | 68788840209 | 90 TABLET in 1 BOTTLE (68788-8402-9)Marketed from Mar 21, 2023 |
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)
- Warfarin Sodium
- Generic name (nonproprietary)
- warfarin
- Active ingredients
- Warfarin sodium — 2.5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202202
- Marketing start
- Listing expires
- Other FDA classes
- Vitamin K Inhibitors (Mechanism)
- Identifiers
- Product ID 68788-8402_3687ceaf-725c-4aea-9708-af212aacf43eSPL ID 3687ceaf-725c-4aea-9708-af212aacf43eSPL set ID ac117f50-8e67-4203-8d97-e53dd0687c20RxCUI 855312UNII 6153CWM0CL
- Pharmacologic class
- Vitamin K Antagonist
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
N468788840201followed by a unit qualifier and the quantityPackage 68788-8402-01. 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)
Warfarin sodium tablets are indicated for: • Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE). • Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (AF) and/or cardiac valve replacement. • Reduction in the risk of death, recurrent myocardial infarction (MI), and thromboembolic events such as stroke or systemic embolization after myocardial infarction. Limitations of Use Warfarin sodium tablets have no direct effect on an established thrombus, nor does it reverse ischemic tissue damage. Once a thrombus has occurred, however, the goals of anticoagulant treatment are to prevent further extension of the formed cl…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 202202
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 |
|---|---|---|---|---|
| Warfarin Sodiumwarfarin | Warfarin sodium 2.5 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1824 |
| Warfarin Sodiumwarfarin | Warfarin sodium 4 mg/1 | TabletOral | Coupler LLC | 67046-1463 |
| Warfarin Sodiumwarfarin | Warfarin sodium 1 mg/1 | TabletOral | Coupler LLC | 67046-2072 |
| Warfarin Sodiumwarfarin | Warfarin sodium 3 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1786 |
| Warfarin Sodium | Warfarin sodium 4 mg/1 | TabletOral | Direct_Rx | 72189-405 |
| Warfarin Sodiumwarfarin | Warfarin sodium 7.5 mg/1 | TabletOral | Coupler LLC | 67046-1525 |
| Warfarin Sodiumwarfarin | Warfarin sodium 1 mg/1 | TabletOral | Amneal Pharmaceuticals LLC | 65162-761 |
| Warfarin Sodiumwarfarin | Warfarin sodium 2 mg/1 | TabletOral | Amneal Pharmaceuticals LLC | 65162-762 |
| Warfarin Sodiumwarfarin | Warfarin sodium 5 mg/1 | TabletOral | Amneal Pharmaceuticals LLC | 65162-766 |
| Warfarin Sodiumwarfarin | Warfarin sodium 2.5 mg/1 | TabletOral | Amneal Pharmaceuticals LLC | 65162-763 |
| Warfarin Sodiumwarfarin | Warfarin sodium 3 mg/1 | TabletOral | Amneal Pharmaceuticals LLC | 65162-764 |
| Warfarin Sodiumwarfarin | Warfarin sodium 4 mg/1 | TabletOral | Amneal Pharmaceuticals LLC | 65162-765 |
| Warfarin Sodiumwarfarin | Warfarin sodium 6 mg/1 | TabletOral | Amneal Pharmaceuticals LLC | 65162-767 |
| Warfarin Sodiumwarfarin | Warfarin sodium 7.5 mg/1 | TabletOral | Amneal Pharmaceuticals LLC | 65162-768 |
| Warfarin Sodiumwarfarin | Warfarin sodium 10 mg/1 | TabletOral | Amneal Pharmaceuticals LLC | 65162-769 |
| Warfarin Sodiumwarfarin | Warfarin sodium 3 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-2380 |
| Warfarin Sodiumwarfarin | Warfarin sodium 2 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-2381 |
| Warfarin Sodiumwarfarin | Warfarin sodium 5 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-2382 |
| Warfarin Sodiumwarfarin | Warfarin sodium 1 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-2383 |
| Warfarin Sodiumwarfarin | Warfarin sodium 6 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-2394 |
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