Prescription drug · ANDA
Phytonadione NDC 65219-635
Phytonadione 10 mg/mL · Injection, Emulsion · Intramuscular, Intravenous, Subcutaneous · Fresenius Kabi USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65219-635-01 | 65219063501 | 2 TRAY in 1 CARTON (65219-635-01) / 5 VIAL, SINGLE-DOSE in 1 TRAY (65219-635-00) / 1 mL in 1 VIAL, SINGLE-DOSEMarketed from May 10, 2025 |
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 — 10 mg/mL
- Dosage form
- Injection, Emulsion
- Route
- Intramuscular, Intravenous, Subcutaneous
- Labeler
- Fresenius Kabi USA, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 219212
- Marketing start
- Listing expires
- Other FDA classes
- Increased Prothrombin Activity (Physiologic effect)Reversed Anticoagulation Activity (Physiologic effect)Vitamin K (Chemical structure)
- Identifiers
- Product ID 65219-635_02a39690-38e6-42e9-9897-391c2df9e07eSPL ID 02a39690-38e6-42e9-9897-391c2df9e07eSPL set ID 02a39690-38e6-42e9-9897-391c2df9e07eRxCUI 1670192UNII 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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N465219063501followed by a unit qualifier and the quantityPackage 65219-0635-01. 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)
INDICATIONS AND USAGE Phytonadione injectable emulsion is indicated in 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. Phytonadione injectable emulsion is indicated in: • anticoagulant-induced prothrombin deficiency caused by coumarin or indanedione derivatives; • prophylaxis and therapy of hemorrhagic disease of the newborn; • hypoprothrombinemia due 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 res…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 219212
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 10 mg/mL | Injection, EmulsionIntramuscular, Intravenous, Subcutaneous | Caplin Steriles Limited | 65145-151 |