Phytonadione NDC 69097-709

NDC codes

FDA NDC Directory

Product NDC (as listed)69097-709Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69097-0709Add 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
69097-709-96	69097070996	10 VIAL in 1 CARTON (69097-709-96) / .5 mL in 1 VIALMarketed from Apr 27, 2022

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 — 1 mg/.5mL
Dosage form: Injection, Emulsion
Route: Intramuscular, Intravenous, Subcutaneous
Labeler: Cipla USA Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 214596
Marketing start: Apr 27, 2022
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 69097-709_b3dd9cac-1295-48b6-b9b1-48d36cb732b9SPL ID b3dd9cac-1295-48b6-b9b1-48d36cb732b9SPL set ID 1add4de5-0f9c-453e-9dd5-abb8077b566aRxCUI 312424, 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

N469097070996 followed by a unit qualifier and the quantity

Package 69097-0709-96. 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 Jul 12, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

Phytonadione injectable emulsion is a vitamin K replacement indicated for the treatment of 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. Anticoagulant-induced hypoprothrombinemia deficiency caused by coumarin or indanedione derivatives; ( 1.1 ) Hypoprothrombinemia due to antibacterial therapy; ( 1.1 ) Hypoprothrombinemia secondary to factors limiting absorption or synthesis of vitamin K, e.g., obstructive jaundice, biliary fistula, sprue, ulcerative colitis, celiac disease, intestinal resection, cystic fibrosis of the pancreas, and regional enteritis; ( 1.1 ) Othe…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 214596

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

FDA NDC Directory listings under ANDA 214596
Product	Strength	Form · route	Labeler	Product NDC
Phytonadione	Phytonadione 10 mg/mL	Injection, EmulsionIntramuscular, Intravenous, Subcutaneous	Cipla USA Inc.	69097-708