Prescription drug · ANDA
Warfarin Sodium NDC 63629-4543
Warfarin sodium 10 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-4543-1 | 6362945430163629454301 | 30 TABLET in 1 BOTTLE (63629-4543-1)Marketed from Jul 22, 2011 | |
| 63629-4543-2 | 6362945430263629454302 | 60 TABLET in 1 BOTTLE (63629-4543-2)Marketed from May 21, 2024 | |
| 63629-4543-3 | 6362945430363629454303 | 90 TABLET in 1 BOTTLE (63629-4543-3)Marketed from Jan 22, 2013 |
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 sodium
- Active ingredients
- Warfarin sodium — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Bryant Ranch PrepackNDC labeler code 63629
- 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 63629-4543_ccaac18e-bb44-4d53-b127-f815859fada6SPL ID ccaac18e-bb44-4d53-b127-f815859fada6SPL set ID 694e258d-86bd-440c-870b-a7d27fb1c467RxCUI 855296UNII 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
N463629454301followed by a unit qualifier and the quantityPackage 63629-4543-01. 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. 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 63629-4543
- What is NDC 63629-4543?
- 63629-4543 is the product NDC for Warfarin Sodium, Warfarin sodium 10 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. It has 3 package NDCs, 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?
- Bryant Ranch Prepack, NDC labeler code 63629. 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 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 |
| Warfarin Sodium | Warfarin sodium 2.5 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-4696 |
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