What is NDC 65219-635?

65219-635 is the product NDC for Phytonadione, Phytonadione 10 mg/mL injection, emulsion, listed with the FDA by Fresenius Kabi USA, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Fresenius Kabi USA, LLC, NDC labeler code 65219. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Phytonadione?

31 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Phytonadione NDC 65219-635 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)65219-635Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65219-0635Add 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 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, LLCNDC labeler code 65219
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 219212
Marketing start: May 10, 2025
Listing expires: Dec 31, 2026
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.

How CPT relates to drug billing

NDC on a medical claim

N465219063501 followed by a unit qualifier and the quantity

Package 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 Apr 17, 2025. 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.

Full label on DailyMed (opens in a new tab)

About NDC 65219-635

What is NDC 65219-635?: 65219-635 is the product NDC for Phytonadione, Phytonadione 10 mg/mL injection, emulsion, listed with the FDA by Fresenius Kabi USA, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Phytonadione.
What is the active ingredient?: Phytonadione.
Who is the labeler?: Fresenius Kabi USA, LLC, NDC labeler code 65219. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Phytonadione?: 31 other product NDCs are listed under this name. See all 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 Phytonadione NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Phytonadione	Phytonadione 5 mg/1	TabletOral	Safecor Health, LLC	48433-160	48433-0160-03
Phytonadione	Phytonadione 1 mg/.5mL	Injection, EmulsionIntramuscular, Intravenous, Subcutaneous	Sun Pharmaceutical Industries, Inc.	70095-154	70095-0154-02
Phytonadione	Phytonadione 10 mg/mL	Injection, EmulsionIntramuscular, Intravenous, Subcutaneous	Amneal Pharmaceuticals Private Limited	80830-1683	80830-1683-03
Phytonadione	Phytonadione 1 mg/.5mL	Injection, EmulsionIntramuscular, Intravenous, Subcutaneous	Orbicular Pharmaceutical Technologies Private Limited	81607-020	81607-0020-02
Phytonadione	Phytonadione 1 mg/.5mL	Injection, EmulsionIntramuscular, Intravenous, Subcutaneous	Baxter Healthcare Corporation	43066-132	43066-0132-10
Phytonadione	Phytonadione 1 mg/.5mL	Injection, EmulsionIntramuscular, Intravenous, Subcutaneous	Sagent Pharmaceuticals	25021-505	25021-0505-70
phytonadione	Phytonadione 1 mg/.5mL	Injection, EmulsionIntramuscular, Intravenous, Subcutaneous	Amneal Pharmaceuticals LLC	70121-1682	70121-1682-07
Phytonadione	Phytonadione 1 mg/.5mL	Injection, EmulsionIntramuscular, Intravenous, Subcutaneous	Alembic Pharmaceuticals Limited	46708-826	46708-0826-0546708-0826-10
Phytonadione	Phytonadione 1 mg/.5mL	Injection, EmulsionIntramuscular, Intravenous, Subcutaneous	Alembic Pharmaceuticals Inc.	62332-826	62332-0826-0562332-0826-10
Phytonadione	Phytonadione 5 mg/1	TabletOral	Coupler LLC	67046-1581	67046-1581-03

All 32 Phytonadione NDCs

Other NDCs under ANDA 219212

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

FDA NDC Directory listings under ANDA 219212
Product	Strength	Form · route	Labeler	Product NDC
Phytonadione	Phytonadione 10 mg/mL	Injection, EmulsionIntramuscular, Intravenous, Subcutaneous	Caplin Steriles Limited	65145-151