Prescription drug · ANDA
Jantoven (Warfarin sodium) NDC 0832-1216
Warfarin sodium 5 mg/1 · Tablet · Oral · Upsher-Smith Laboratories, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0832-1216-00 | 0083212160000832121600 | 100 TABLET in 1 BOTTLE (0832-1216-00)Marketed from Feb 23, 2010 | |
| 0832-1216-01 | 0083212160100832121601 | 100 BLISTER PACK in 1 CARTON (0832-1216-01) / 1 TABLET in 1 BLISTER PACK (0832-1216-89)Marketed from Feb 23, 2010 | |
| 0832-1216-10 | 0083212161000832121610 | 1000 TABLET in 1 BOTTLE (0832-1216-10)Marketed from Feb 23, 2010 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Jantoven
- Generic name (nonproprietary)
- warfarin sodium
- Active ingredients
- Warfarin sodium — 5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Upsher-Smith Laboratories, LLCNDC labeler code 0832
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040416
- Marketing start
- Listing expires
- Other FDA classes
- Vitamin K Inhibitors (Mechanism)
- Identifiers
- Product ID 0832-1216_396ff415-9bf2-8f45-e063-6394a90af63eSPL ID 396ff415-9bf2-8f45-e063-6394a90af63eSPL set ID 19a69a72-ac5d-45d5-a94d-a5aaecbe4730RxCUI 855288, 855292, 855296, 855300, 855302, 855306, 855312, 855316, 855318, 855322, 855324, 855328, 855332, 855336, 855338, 855342, 855344, 855348UNII 6153CWM0CLUPC 0308321217009, 0308321212004, 0308321215005, 0308321211007
- 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
N400832121600followed by a unit qualifier and the quantityPackage 00832-1216-00. 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)
JANTOVEN ® is 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 prevent secondary t…
Excerpt only. Read the full label for complete information.
About NDC 0832-1216
- What is NDC 0832-1216?
- 0832-1216 is the product NDC for Jantoven (warfarin sodium), Warfarin sodium 5 mg/1 tablet, listed with the FDA by Upsher-Smith Laboratories, LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Jantoven (Warfarin Sodium).
- What is the active ingredient?
- Warfarin sodium.
- Who is the labeler?
- Upsher-Smith Laboratories, LLC, NDC labeler code 0832. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Jantoven?
- 8 other product NDCs are listed under this name. See all Jantoven NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Jantoven products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Jantovenwarfarin sodium | Warfarin sodium 1 mg/1 | TabletOral | Upsher-Smith Laboratories, LLC | 0832-1211 | 00832-1211-0000832-1211-0100832-1211-10 |
| Jantovenwarfarin sodium | Warfarin sodium 2 mg/1 | TabletOral | Upsher-Smith Laboratories, LLC | 0832-1212 | 00832-1212-0000832-1212-0100832-1212-10 |
| Jantovenwarfarin sodium | Warfarin sodium 2.5 mg/1 | TabletOral | Upsher-Smith Laboratories, LLC | 0832-1213 | 00832-1213-0000832-1213-0100832-1213-10 |
| Jantovenwarfarin sodium | Warfarin sodium 3 mg/1 | TabletOral | Upsher-Smith Laboratories, LLC | 0832-1214 | 00832-1214-0000832-1214-0100832-1214-10 |
| Jantovenwarfarin sodium | Warfarin sodium 4 mg/1 | TabletOral | Upsher-Smith Laboratories, LLC | 0832-1215 | 00832-1215-0000832-1215-0100832-1215-10 |
| Jantovenwarfarin sodium | Warfarin sodium 6 mg/1 | TabletOral | Upsher-Smith Laboratories, LLC | 0832-1217 | 00832-1217-0000832-1217-0100832-1217-10 |
| Jantovenwarfarin sodium | Warfarin sodium 7.5 mg/1 | TabletOral | Upsher-Smith Laboratories, LLC | 0832-1218 | 00832-1218-0000832-1218-0100832-1218-50 |
| Jantovenwarfarin sodium | Warfarin sodium 10 mg/1 | TabletOral | Upsher-Smith Laboratories, LLC | 0832-1219 | 00832-1219-0000832-1219-0100832-1219-50 |
Other NDCs under ANDA 040416
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 |
|---|---|---|---|---|
| Jantovenwarfarin sodium | Warfarin sodium 1 mg/1 | TabletOral | Upsher-Smith Laboratories, LLC | 0832-1211 |
| Jantovenwarfarin sodium | Warfarin sodium 2 mg/1 | TabletOral | Upsher-Smith Laboratories, LLC | 0832-1212 |
| Jantovenwarfarin sodium | Warfarin sodium 2.5 mg/1 | TabletOral | Upsher-Smith Laboratories, LLC | 0832-1213 |
| Jantovenwarfarin sodium | Warfarin sodium 3 mg/1 | TabletOral | Upsher-Smith Laboratories, LLC | 0832-1214 |
| Jantovenwarfarin sodium | Warfarin sodium 4 mg/1 | TabletOral | Upsher-Smith Laboratories, LLC | 0832-1215 |
| Jantovenwarfarin sodium | Warfarin sodium 6 mg/1 | TabletOral | Upsher-Smith Laboratories, LLC | 0832-1217 |
| Jantovenwarfarin sodium | Warfarin sodium 7.5 mg/1 | TabletOral | Upsher-Smith Laboratories, LLC | 0832-1218 |
| Jantovenwarfarin sodium | Warfarin sodium 10 mg/1 | TabletOral | Upsher-Smith Laboratories, LLC | 0832-1219 |