NDC codes

FDA NDC Directory
Product NDC (as listed)51662-1698Labeler and product segments. Claims need a package NDC.
Product NDC at billing width51662-1698Add 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
51662-1698-35166216980325 POUCH in 1 CASE (51662-1698-3) / 1 AMPULE in 1 POUCH (51662-1698-2) / 1 mL in 1 AMPULEMarketed from May 31, 2019

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)
Phytonadione
Generic name (nonproprietary)
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 207719
Marketing start
Listing expires
Other FDA classes
Increased Prothrombin Activity (Physiologic effect)Reversed Anticoagulation Activity (Physiologic effect)Vitamin K (Chemical structure)
Identifiers
Product ID 51662-1698_596cedea-ae71-a84f-e063-6394a90a54dfSPL ID 596cedea-ae71-a84f-e063-6394a90a54dfSPL set ID 5686f34b-446a-00ae-e063-6394a90a6029RxCUI 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

N451662169803 followed by a unit qualifier and the quantity

Package 51662-1698-03. 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)

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 resection, cystic fib…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 51662-1698

What is NDC 51662-1698?
51662-1698 is the product NDC for 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?
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 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
PhytonadionePhytonadione 5 mg/1TabletOralSafecor Health, LLC48433-16048433-0160-03
PhytonadionePhytonadione 1 mg/.5mLInjection, EmulsionIntramuscular, Intravenous, SubcutaneousSun Pharmaceutical Industries, Inc.70095-15470095-0154-02
PhytonadionePhytonadione 10 mg/mLInjection, EmulsionIntramuscular, Intravenous, SubcutaneousAmneal Pharmaceuticals Private Limited80830-168380830-1683-03
PhytonadionePhytonadione 1 mg/.5mLInjection, EmulsionIntramuscular, Intravenous, SubcutaneousOrbicular Pharmaceutical Technologies Private Limited81607-02081607-0020-02
PhytonadionePhytonadione 1 mg/.5mLInjection, EmulsionIntramuscular, Intravenous, SubcutaneousBaxter Healthcare Corporation43066-13243066-0132-10
PhytonadionePhytonadione 1 mg/.5mLInjection, EmulsionIntramuscular, Intravenous, SubcutaneousSagent Pharmaceuticals25021-50525021-0505-70
phytonadionePhytonadione 1 mg/.5mLInjection, EmulsionIntramuscular, Intravenous, SubcutaneousAmneal Pharmaceuticals LLC70121-168270121-1682-07
PhytonadionePhytonadione 1 mg/.5mLInjection, EmulsionIntramuscular, Intravenous, SubcutaneousAlembic Pharmaceuticals Limited46708-82646708-0826-0546708-0826-10
PhytonadionePhytonadione 1 mg/.5mLInjection, EmulsionIntramuscular, Intravenous, SubcutaneousAlembic Pharmaceuticals Inc.62332-82662332-0826-0562332-0826-10
PhytonadionePhytonadione 5 mg/1TabletOralCoupler LLC67046-158167046-1581-03

All 32 Phytonadione NDCs

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
ProductStrengthForm · routeLabelerProduct NDC
PhytonadionePhytonadione 10 mg/mLInjection, EmulsionIntramuscular, Intravenous, SubcutaneousHenry Schein, Inc.0404-9969
Phytonadione PhytonadionephytonadionePhytonadione 10 mg/mLInjection, EmulsionIntramuscular, Intravenous, SubcutaneousDr.Reddy's Laboratories Inc43598-405

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