Prescription drug · ANDA
Vitamin K1 Phytonadione (Vitamin k1, phytonadione) NDC 51662-1537
Phytonadione 2 mg/mL · Injection, Emulsion · Intramuscular, Intravenous, Subcutaneous · HF Acquisition Co LLC, DBA HealthFirst
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51662-1537-3 | 51662153703 | 25 POUCH in 1 BOX (51662-1537-3) / 1 AMPULE in 1 POUCH (51662-1537-2) / .5 mL in 1 AMPULEMarketed from Nov 1, 2021 |
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)
- Vitamin K1 Phytonadione
- Generic name (nonproprietary)
- vitamin k1, phytonadione
- Active ingredients
- Phytonadione — 2 mg/mL
- Dosage form
- Injection, Emulsion
- Route
- Intramuscular, Intravenous, Subcutaneous
- Labeler
- HF Acquisition Co LLC, DBA HealthFirstNDC labeler code 51662
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 087954
- Marketing start
- Listing expires
- Other FDA classes
- Increased Prothrombin Activity (Physiologic effect)Reversed Anticoagulation Activity (Physiologic effect)Vitamin K (Chemical structure)
- Identifiers
- Product ID 51662-1537_540025e9-458e-1cc2-e063-6294a90a9667SPL ID 540025e9-458e-1cc2-e063-6294a90a9667SPL set ID cfc0df9f-ee59-9e30-e053-2995a90ad449RxCUI 312424UNII 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
N451662153703followed by a unit qualifier and the quantityPackage 51662-1537-03. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
INDICATIONS & USAGE Vitamin K1 Injection (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. Vitamin K1 Injection 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, intestin…
Excerpt only. Read the full label for complete information.
About NDC 51662-1537
- What is NDC 51662-1537?
- 51662-1537 is the product NDC for Vitamin K1 Phytonadione, Phytonadione 2 mg/mL injection, emulsion, listed with the FDA by HF Acquisition Co LLC, DBA HealthFirst. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Vitamin K1 Phytonadione (Vitamin k1, Phytonadione).
- What is the active ingredient?
- Phytonadione.
- Who is the labeler?
- HF Acquisition Co LLC, DBA HealthFirst, NDC labeler code 51662. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Vitamin K1 Phytonadione?
- 1 other product NDC are listed under this name. See all Vitamin K1 Phytonadione NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Vitamin K1 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) |
|---|---|---|---|---|---|
| Vitamin K1 - Phytonadione | Phytonadione 10 mg/mL | Injection, EmulsionIntramuscular, Intravenous, Subcutaneous | HF Acquisition Co LLC, DBA HealthFirst | 51662-1536 | 51662-1536-03 |
Other NDCs under ANDA 087954
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 |
|---|---|---|---|---|
| Vitamin K1phytonadione | Phytonadione 2 mg/mL | Injection, EmulsionIntramuscular, Intravenous, Subcutaneous | Hospira, Inc. | 0409-9157 |