Prescription drug · ANDA
Phytonadione NDC 69097-999
Phytonadione 5 mg/1 · Tablet · Oral · Cipla USA., Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69097-999-02 | 69097099902 | 30 TABLET in 1 BOTTLE (69097-999-02)Marketed from Dec 1, 2023 | |
| 69097-999-07 | 69097099907 | 100 TABLET in 1 BOTTLE (69097-999-07)Marketed from Dec 1, 2023 |
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)
- Phytonadione
- Generic name (nonproprietary)
- phytonadione
- Active ingredients
- Phytonadione — 5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Cipla USA., Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213329
- Marketing start
- Listing expires
- Other FDA classes
- Increased Prothrombin Activity (Physiologic effect)Reversed Anticoagulation Activity (Physiologic effect)Vitamin K (Chemical structure)
- Identifiers
- Product ID 69097-999_82b768e9-502a-4b78-8200-c6bc4d0d76b1SPL ID 82b768e9-502a-4b78-8200-c6bc4d0d76b1SPL set ID 7dd1f275-94d3-45d2-a4d0-696ce60a2a9bRxCUI 198102UNII A034SE7857UPC 0369097999070, 0369097999025
- 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
N469097099902followed by a unit qualifier and the quantityPackage 69097-0999-02. 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 absorpsion 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.
Other NDCs under ANDA 213329
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 | ScieGen Pharmaceuticals Inc | 50228-333 |
| Phytonadione | Phytonadione 5 mg/1 | TabletOral | Exelan Pharmaceuticals, Inc. | 76282-740 |