Prescription drug · ANDA
Phytonadione NDC 67046-1581
Phytonadione 5 mg/1 · Tablet · Oral · Coupler LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67046-1581-3 | 67046158103 | 30 TABLET in 1 BLISTER PACK (67046-1581-3)Marketed from Sep 8, 2025 |
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)
- Phytonadione
- Generic name (nonproprietary)
- phytonadione
- Active ingredients
- Phytonadione — 5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Coupler LLCNDC labeler code 67046
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210189
- Marketing start
- Listing expires
- Other FDA classes
- Increased Prothrombin Activity (Physiologic effect)Reversed Anticoagulation Activity (Physiologic effect)Vitamin K (Chemical structure)
- Identifiers
- Product ID 67046-1581_3e4f86c4-7e70-c864-e063-6394a90a59afSPL ID 3e4f86c4-7e70-c864-e063-6394a90a59afSPL set ID 3e4f86c4-7e89-c864-e063-6394a90a59afRxCUI 198102UNII A034SE7857
- Pharmacologic class
- Vitamin K; Warfarin Reversal Agent
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
N467046158103followed by a unit qualifier and the quantityPackage 67046-1581-03. 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 .
Indications (excerpt from the label)
Phytonadione is indicated for the treatment of adults with the following coagulation disorders which are due to faulty formation of factors II, VII, IX and X when caused by vitamin K deficiency or interference with vitamin K activity. anticoagulant-induced hypoprothrombinemia caused by coumarin or indanedione derivatives; hypoprothrombinemia secondary to antibacterial therapy; hypoprothrombinemia secondary to factors limiting absorption or synthesis of vitamin K, e.g., obstructive jaundice, biliary fistula, sprue, ulcerative colitis, celiac disease, intestinal resection, cystic fibrosis of the pancrease, and regional enteritis; Other drug-induced hypoprothrombinemia where it is definitely sh…
Excerpt only. Read the full label for complete information.
About NDC 67046-1581
- What is NDC 67046-1581?
- 67046-1581 is the product NDC for Phytonadione, Phytonadione 5 mg/1 tablet, listed with the FDA by Coupler LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Phytonadione.
- What is the active ingredient?
- Phytonadione.
- Who is the labeler?
- Coupler LLC, NDC labeler code 67046. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Phytonadione?
- 31 other product NDCs are listed under this name. See all Phytonadione NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Phytonadione products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Phytonadione | Phytonadione 5 mg/1 | TabletOral | Safecor Health, LLC | 48433-160 | 48433-0160-03 |
| Phytonadione | Phytonadione 1 mg/.5mL | Injection, EmulsionIntramuscular, Intravenous, Subcutaneous | Sun Pharmaceutical Industries, Inc. | 70095-154 | 70095-0154-02 |
| Phytonadione | Phytonadione 10 mg/mL | Injection, EmulsionIntramuscular, Intravenous, Subcutaneous | Amneal Pharmaceuticals Private Limited | 80830-1683 | 80830-1683-03 |
| Phytonadione | Phytonadione 1 mg/.5mL | Injection, EmulsionIntramuscular, Intravenous, Subcutaneous | Orbicular Pharmaceutical Technologies Private Limited | 81607-020 | 81607-0020-02 |
| Phytonadione | Phytonadione 1 mg/.5mL | Injection, EmulsionIntramuscular, Intravenous, Subcutaneous | Baxter Healthcare Corporation | 43066-132 | 43066-0132-10 |
| Phytonadione | Phytonadione 1 mg/.5mL | Injection, EmulsionIntramuscular, Intravenous, Subcutaneous | Sagent Pharmaceuticals | 25021-505 | 25021-0505-70 |
| phytonadione | Phytonadione 1 mg/.5mL | Injection, EmulsionIntramuscular, Intravenous, Subcutaneous | Amneal Pharmaceuticals LLC | 70121-1682 | 70121-1682-07 |
| Phytonadione | Phytonadione 1 mg/.5mL | Injection, EmulsionIntramuscular, Intravenous, Subcutaneous | Alembic Pharmaceuticals Limited | 46708-826 | 46708-0826-0546708-0826-10 |
| Phytonadione | Phytonadione 1 mg/.5mL | Injection, EmulsionIntramuscular, Intravenous, Subcutaneous | Alembic Pharmaceuticals Inc. | 62332-826 | 62332-0826-0562332-0826-10 |
| Phytonadione | Phytonadione 10 mg/mL | Injection, EmulsionIntramuscular, Intravenous, Subcutaneous | Xiromed LLC | 70700-331 | 70700-0331-25 |
Other NDCs under ANDA 210189
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 |
|---|---|---|---|---|
| Phytonadione | Phytonadione 5 mg/1 | TabletOral | Northstar Rx LLC. | 16714-973 |
| Phytonadione | Phytonadione 5 mg/1 | TabletOral | Safecor Health, LLC | 48433-160 |
| Phytonadione | Phytonadione 5 mg/1 | TabletOral | Zydus Pharmaceuticals USA Inc. | 70710-1014 |
| Phytonadione | Phytonadione 5 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1318 |