Prescription drug · ANDA
Phytonadione NDC 0404-9969
Phytonadione 10 mg/mL · Injection, Emulsion · Intramuscular, Intravenous, Subcutaneous · Henry Schein, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0404-9969-01 | 00404996901 | 1 AMPULE in 1 BAG (0404-9969-01) / 1 mL in 1 AMPULEMarketed from Jan 10, 2022 |
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)
- Phytonadione
- Generic name (nonproprietary)
- phytonadione
- Active ingredients
- Phytonadione — 10 mg/mL
- Dosage form
- Injection, Emulsion
- Route
- Intramuscular, Intravenous, Subcutaneous
- Labeler
- Henry Schein, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207719
- Marketing start
- Listing expires
- Other FDA classes
- Increased Prothrombin Activity (Physiologic effect)Reversed Anticoagulation Activity (Physiologic effect)Vitamin K (Chemical structure)
- Identifiers
- Product ID 0404-9969_219e0da6-2fee-450f-ba9c-ff2595f90b69SPL ID 219e0da6-2fee-450f-ba9c-ff2595f90b69SPL set ID 1cf90be3-a744-4db5-999d-a84c67372304RxCUI 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
N400404996901followed by a unit qualifier and the quantityPackage 00404-9969-01. 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, USP 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 resec…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 207719
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 Phytonadionephytonadione | Phytonadione 10 mg/mL | Injection, EmulsionIntramuscular, Intravenous, Subcutaneous | Dr.Reddy's Laboratories Inc | 43598-405 |
| Phytonadione | Phytonadione 10 mg/mL | Injection, EmulsionIntramuscular, Intravenous, Subcutaneous | HF Acquisition Co LLC, DBA HealthFirst | 51662-1698 |