Prescription drug · ANDA
Warfarin Sodium NDC 71335-0452
Warfarin sodium 4 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-0452-1 | 7133504520171335045201 | 30 TABLET in 1 BOTTLE (71335-0452-1)Marketed from Feb 9, 2022 | |
| 71335-0452-2 | 7133504520271335045202 | 60 TABLET in 1 BOTTLE (71335-0452-2)Marketed from Feb 9, 2022 | |
| 71335-0452-3 | 7133504520371335045203 | 90 TABLET in 1 BOTTLE (71335-0452-3)Marketed from Feb 9, 2022 | |
| 71335-0452-4 | 7133504520471335045204 | 100 TABLET in 1 BOTTLE (71335-0452-4)Marketed from Feb 9, 2022 |
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 — 4 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Bryant Ranch PrepackNDC labeler code 71335
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040616
- Marketing start
- Listing expires
- Other FDA classes
- Vitamin K Inhibitors (Mechanism)
- Identifiers
- Product ID 71335-0452_47fbc4b8-a0b5-4eb8-9b18-128cdb07dd81SPL ID 47fbc4b8-a0b5-4eb8-9b18-128cdb07dd81SPL set ID d166f83b-7052-4dc7-b7d4-47faae7dcaedRxCUI 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
N471335045201followed by a unit qualifier and the quantityPackage 71335-0452-01. 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 clot and…
Excerpt only. Read the full label for complete information.
About NDC 71335-0452
- What is NDC 71335-0452?
- 71335-0452 is the product NDC for Warfarin Sodium, Warfarin sodium 4 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. It has 4 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 71335. 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 040616
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 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-0255 |
| Warfarin Sodium | Warfarin sodium 6 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-0261 |
| Warfarin Sodium | Warfarin sodium 4 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-0280 |
| Warfarin Sodium | Warfarin sodium 10 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-0266 |
| Warfarin Sodium | Warfarin sodium 3 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-0273 |
| Warfarin Sodium | Warfarin sodium 5 mg/1 | TabletOral | A-S Medication Solutions | 50090-5439 |
| Warfarin Sodium | Warfarin sodium 5 mg/1 | TabletOral | A-S Medication Solutions | 50090-5440 |
| Warfarin Sodium | Warfarin sodium 5 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-8843 |
| Warfarin Sodium | Warfarin sodium 2 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-993 |
| Warfarin Sodium | Warfarin sodium 10 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0840 |
| Warfarin Sodium | Warfarin sodium 5 mg/1 | TabletOral | Proficient Rx LP | 63187-674 |
| Warfarin Sodium | Warfarin sodium 5 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0243 |
| Warfarin Sodium | Warfarin sodium 1 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-0727 |
| Warfarin Sodium | Warfarin sodium 1 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0270 |
| Warfarin Sodium | Warfarin sodium 2 mg/1 | TabletOral | A-S Medication Solutions | 50090-7464 |
| Warfarin Sodium | Warfarin sodium 2.5 mg/1 | TabletOral | Proficient Rx LP | 63187-745 |
| Warfarin Sodium | Warfarin sodium 10 mg/1 | TabletOral | Proficient Rx LP | 63187-750 |
| Warfarin Sodium | Warfarin sodium 2.5 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0348 |
| Warfarin Sodium | Warfarin sodium 1 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-620 |
| Warfarin Sodium | Warfarin sodium 5 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-629 |
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