Prescription drug · ANDA
Warfarin Sodium (warfarin) NDC 76282-327
Warfarin sodium 1 mg/1 · Tablet · Oral · Exelan Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76282-327-01 | 76282032701 | 100 TABLET in 1 BOTTLE (76282-327-01)Marketed from Apr 8, 2015 | |
| 76282-327-10 | 76282032710 | 1000 TABLET in 1 BOTTLE (76282-327-10)Marketed from Apr 8, 2015 |
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)
- Warfarin Sodium
- Generic name (nonproprietary)
- warfarin
- Active ingredients
- Warfarin sodium — 1 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Exelan Pharmaceuticals Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090935
- Marketing start
- Listing expires
- Other FDA classes
- Vitamin K Inhibitors (Mechanism)
- Identifiers
- Product ID 76282-327_45e85c4e-ae91-4cf3-bd98-1d5b5aecc7c5SPL ID 45e85c4e-ae91-4cf3-bd98-1d5b5aecc7c5SPL set ID c0cc4511-e656-4b6d-96cd-e02e76173b9dRxCUI 855288, 855296, 855302, 855312, 855318, 855324, 855332, 855338, 855344UNII 6153CWM0CLUPC 0376282327013, 0376282335018, 0376282334011, 0376282332017, 0376282328010, 0376282330013, 0376282329017, 0376282333014, 0376282331010
- 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
N476282032701followed by a unit qualifier and the quantityPackage 76282-0327-01. 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)
1. INDICATIONS AND USAGE 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 extens…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 090935
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 | Aphena Pharma Solutions - Tennessee, LLC | 71610-491 |
| Warfarin Sodiumwarfarin | Warfarin sodium 4 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-490 |
| Warfarin Sodiumwarfarin | Warfarin sodium 2 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 43353-021 |
| Warfarin Sodiumwarfarin | Warfarin sodium 3 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 43353-030 |
| Warfarin Sodiumwarfarin | Warfarin sodium 5 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 43353-023 |
| Warfarin Sodiumwarfarin | Warfarin sodium 2.5 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 43353-029 |
| Warfarin Sodiumwarfarin | Warfarin sodium 4 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 43353-033 |
| Warfarin Sodiumwarfarin | Warfarin sodium 7.5 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 43353-053 |
| Warfarin Sodiumwarfarin | Warfarin sodium 10 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 43353-054 |
| Warfarin Sodiumwarfarin | Warfarin sodium 2.5 mg/1 | TabletOral | Exelan Pharmaceuticals Inc. | 76282-329 |
| Warfarin Sodiumwarfarin | Warfarin sodium 2 mg/1 | TabletOral | Exelan Pharmaceuticals Inc. | 76282-328 |
| Warfarin Sodiumwarfarin | Warfarin sodium 6 mg/1 | TabletOral | Exelan Pharmaceuticals Inc. | 76282-333 |
| Warfarin Sodiumwarfarin | Warfarin sodium 3 mg/1 | TabletOral | Exelan Pharmaceuticals Inc. | 76282-330 |
| Warfarin Sodiumwarfarin | Warfarin sodium 4 mg/1 | TabletOral | Exelan Pharmaceuticals Inc. | 76282-331 |
| Warfarin Sodiumwarfarin | Warfarin sodium 5 mg/1 | TabletOral | Exelan Pharmaceuticals Inc. | 76282-332 |
| Warfarin Sodiumwarfarin | Warfarin sodium 7.5 mg/1 | TabletOral | Exelan Pharmaceuticals Inc. | 76282-334 |
| Warfarin Sodiumwarfarin | Warfarin sodium 10 mg/1 | TabletOral | Exelan Pharmaceuticals Inc. | 76282-335 |
| Warfarin Sodium | Warfarin sodium 10 mg/1 | TabletOral | DIRECT RX | 72189-210 |
| Warfarin Sodiumwarfarin | Warfarin sodium 4 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-345 |
| Warfarin Sodiumwarfarin | Warfarin sodium 2 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-342 |
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