NDC codes

FDA NDC Directory
Product NDC (as listed)51662-1536Labeler and product segments. Claims need a package NDC.
Product NDC at billing width51662-1536Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
51662-1536-35166215360325 POUCH in 1 BOX (51662-1536-3) / 1 AMPULE in 1 POUCH (51662-1536-2) / 1 mL in 1 AMPULEMarketed from May 10, 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 — 10 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 087955
Marketing start
Listing expires
Other FDA classes
Increased Prothrombin Activity (Physiologic effect)Reversed Anticoagulation Activity (Physiologic effect)Vitamin K (Chemical structure)
Identifiers
Product ID 51662-1536_1034ddca-fc35-505d-e063-6394a90a92c3SPL ID 1034ddca-fc35-505d-e063-6394a90a92c3SPL set ID c204c720-88d3-a6d6-e053-2a95a90a3de5RxCUI 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.

How CPT relates to drug billing

NDC on a medical claim

N451662153603 followed by a unit qualifier and the quantity

Package 51662-1536-03. 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.

Full label on DailyMed (opens in a new tab)

About NDC 51662-1536

What is NDC 51662-1536?
51662-1536 is the product NDC for Vitamin K1 - Phytonadione, Phytonadione 10 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.
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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Vitamin K1 - Phytonadione NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Vitamin K1 Phytonadionevitamin k1, phytonadionePhytonadione 2 mg/mLInjection, EmulsionIntramuscular, Intravenous, SubcutaneousHF Acquisition Co LLC, DBA HealthFirst51662-153751662-1537-03

Other NDCs under ANDA 087955

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 087955
ProductStrengthForm · routeLabelerProduct NDC
Vitamin K1phytonadionePhytonadione 10 mg/mLInjection, EmulsionIntramuscular, Intravenous, SubcutaneousHospira, Inc.0409-9158

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