What is NDC 43598-405?

43598-405 is the product NDC for Phytonadione Phytonadione (phytonadione), Phytonadione 10 mg/mL injection, emulsion, listed with the FDA by Dr.Reddy's Laboratories Inc. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Phytonadione Phytonadione (Phytonadione).

Dr.Reddy's Laboratories Inc, NDC labeler code 43598. 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 Phytonadione?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Phytonadione Phytonadione NDC 43598-405

NDC codes

FDA NDC Directory

Product NDC (as listed)43598-405Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43598-0405Add 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
43598-405-16	4359804051643598040516	25 AMPULE in 1 CARTON (43598-405-16) / 1 mL in 1 AMPULE (43598-405-11)Marketed from May 31, 2019

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 PhytonadioneSuffix: PHYTONADIONE
Generic name (nonproprietary): phytonadione
Active ingredients: Phytonadione — 10 mg/mL
Dosage form: Injection, Emulsion
Route: Intramuscular, Intravenous, Subcutaneous
Labeler: Dr.Reddy's Laboratories IncNDC labeler code 43598
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 207719
Marketing start: May 31, 2019
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 43598-405_c4a2bf44-0ad2-c0d2-164f-562ba6df930cSPL ID c4a2bf44-0ad2-c0d2-164f-562ba6df930cSPL set ID 02445c07-7b4b-cd70-54e8-ebefc814f547RxCUI 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

N443598040516 followed by a unit qualifier and the quantity

Package 43598-0405-16. 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 May 30, 2019. 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…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 43598-405

What is NDC 43598-405?: 43598-405 is the product NDC for Phytonadione Phytonadione (phytonadione), Phytonadione 10 mg/mL injection, emulsion, listed with the FDA by Dr.Reddy's Laboratories Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Phytonadione Phytonadione (Phytonadione).
What is the active ingredient?: Phytonadione.
Who is the labeler?: Dr.Reddy's Laboratories Inc, NDC labeler code 43598. 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 Phytonadione?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other NDCs under ANDA 207719

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

FDA NDC Directory listings under ANDA 207719
Product	Strength	Form · route	Labeler	Product NDC
Phytonadione	Phytonadione 10 mg/mL	Injection, EmulsionIntramuscular, Intravenous, Subcutaneous	Henry Schein, Inc.	0404-9969
Phytonadione	Phytonadione 10 mg/mL	Injection, EmulsionIntramuscular, Intravenous, Subcutaneous	HF Acquisition Co LLC, DBA HealthFirst	51662-1698

Phytonadione Phytonadione (Phytonadione) NDC 43598-405