Prescription drug · ANDA
Warfarin Sodium NDC 62584-994
Warfarin sodium 5 mg/1 · Tablet · Oral · American Health Packaging
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62584-994-01 | 6258409940162584099401 | 100 BLISTER PACK in 1 BOX, UNIT-DOSE (62584-994-01) / 1 TABLET in 1 BLISTER PACK (62584-994-11)Marketed from Jun 1, 2005 |
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 — 5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- American Health PackagingNDC labeler code 62584
- 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 62584-994_23a9088f-f68f-a37f-e063-6394a90a5658SPL ID 23a9088f-f68f-a37f-e063-6394a90a5658SPL set ID ab047628-67d0-4a64-8d77-36b054969b44RxCUI 855302, 855332UNII 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
N462584099401followed by a unit qualifier and the quantityPackage 62584-0994-01. 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, 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. Limitations of Use Warfarin sodium has 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 clot and to …
Excerpt only. Read the full label for complete information.
About NDC 62584-994
- What is NDC 62584-994?
- 62584-994 is the product NDC for Warfarin Sodium, Warfarin sodium 5 mg/1 tablet, listed with the FDA by American Health Packaging. 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?
- American Health Packaging, NDC labeler code 62584. 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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