Prescription drug · ANDA
Warfarin Sodium NDC 71610-593
Warfarin sodium 2.5 mg/1 · Tablet · Oral · Aphena Pharma Solutions - Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71610-593-30 | 7161005933071610059330 | 30 TABLET in 1 BOTTLE (71610-593-30)Marketed from Aug 16, 2021 |
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 sodium
- Active ingredients
- Warfarin sodium — 2.5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Aphena Pharma Solutions - Tennessee, LLCNDC labeler code 71610
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040301
- Marketing start
- Listing expires
- Other FDA classes
- Vitamin K Inhibitors (Mechanism)
- Identifiers
- Product ID 71610-593_3673e690-2fb5-4235-94a8-dd46c7cee8b9SPL ID 3673e690-2fb5-4235-94a8-dd46c7cee8b9SPL set ID e73d37f8-8a28-4d93-9529-fd1e2c84228aRxCUI 855312, 855324UNII 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
N471610059330followed by a unit qualifier and the quantityPackage 71610-0593-30. 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, USP 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. Warfarin sodium is a vitamin K antagonist indicated for: Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism ( 1 ) Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation and/or cardiac valve …
Excerpt only. Read the full label for complete information.
About NDC 71610-593
- What is NDC 71610-593?
- 71610-593 is the product NDC for Warfarin Sodium, Warfarin sodium 2.5 mg/1 tablet, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Warfarin Sodium.
- What is the active ingredient?
- Warfarin sodium.
- Who is the labeler?
- Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 71610. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Warfarin Sodium?
- 138 other product NDCs are listed under this name. See all Warfarin Sodium NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Warfarin Sodium products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Warfarin Sodiumwarfarin | Warfarin sodium 2.5 mg/1 | TabletOral | Coupler LLC | 67046-1145 | 67046-1145-03 |
| Warfarin Sodiumwarfarin | Warfarin sodium 3 mg/1 | TabletOral | Coupler LLC | 67046-1185 | 67046-1185-03 |
| Warfarin Sodium | Warfarin sodium 3 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4722 | 70518-4722-00 |
| Warfarin Sodiumwarfarin | Warfarin sodium 10 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4684 | 70518-4684-00 |
| Warfarin Sodiumwarfarin | Warfarin sodium 1 mg/1 | TabletOral | Coupler LLC | 67046-2072 | 67046-2072-03 |
| Warfarin Sodiumwarfarin | Warfarin sodium 2 mg/1 | TabletOral | Coupler LLC | 67046-1067 | 67046-1067-03 |
| Warfarin Sodium | Warfarin sodium 2.5 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4634 | 70518-4634-00 |
| Warfarin Sodium | Warfarin sodium 7.5 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4635 | 70518-4635-00 |
| Warfarin Sodium | Warfarin sodium 10 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4636 | 70518-4636-00 |
| Warfarin Sodium | Warfarin sodium 1 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4637 | 70518-4637-00 |
Other NDCs under ANDA 040301
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 Sodium | Warfarin sodium 2.5 mg/1 | TabletOral | American Health Packaging | 68084-027 |
| Warfarin Sodium | Warfarin sodium 3 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4722 |
| Warfarin Sodium | Warfarin sodium 1 mg/1 | TabletOral | A-S Medication Solutions | 50090-7999 |
| Warfarin Sodium | Warfarin sodium 10 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-4543 |
| Warfarin Sodium | Warfarin sodium 2 mg/1 | TabletOral | A-S Medication Solutions | 50090-1211 |
| Warfarin Sodium | Warfarin sodium 1 mg/1 | TabletOral | Sun Pharmaceutical Industries, Inc. | 51672-4027 |
| Warfarin Sodium | Warfarin sodium 4 mg/1 | TabletOral | Sun Pharmaceutical Industries, Inc. | 51672-4031 |
| Warfarin Sodium | Warfarin sodium 2 mg/1 | TabletOral | Sun Pharmaceutical Industries, Inc. | 51672-4028 |
| Warfarin Sodium | Warfarin sodium 2.5 mg/1 | TabletOral | Sun Pharmaceutical Industries, Inc. | 51672-4029 |
| Warfarin Sodium | Warfarin sodium 3 mg/1 | TabletOral | Sun Pharmaceutical Industries, Inc. | 51672-4030 |
| Warfarin Sodium | Warfarin sodium 2.5 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-786 |
| Warfarin Sodium | Warfarin sodium 7.5 mg/1 | TabletOral | Sun Pharmaceutical Industries, Inc. | 51672-4034 |
| Warfarin Sodium | Warfarin sodium 5 mg/1 | TabletOral | Sun Pharmaceutical Industries, Inc. | 51672-4032 |
| Warfarin Sodium | Warfarin sodium 1 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-784 |
| Warfarin Sodium | Warfarin sodium 2 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-785 |
| Warfarin Sodium | Warfarin sodium 6 mg/1 | TabletOral | Sun Pharmaceutical Industries, Inc. | 51672-4033 |
| Warfarin Sodium | Warfarin sodium 5 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-789 |
| Warfarin Sodium | Warfarin sodium 10 mg/1 | TabletOral | Sun Pharmaceutical Industries, Inc. | 51672-4035 |
| Warfarin Sodium | Warfarin sodium 3 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-787 |
| Warfarin Sodium | Warfarin sodium 4 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-788 |
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