What is NDC 50228-333?

50228-333 is the product NDC for Phytonadione, Phytonadione 5 mg/1 tablet, listed with the FDA by ScieGen Pharmaceuticals Inc. It has 2 package NDCs, shown above in 10- and 11-digit form.

ScieGen Pharmaceuticals Inc, NDC labeler code 50228. 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?

32 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 50228-333 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)50228-333Labeler and product segments. Claims need a package NDC.

Product NDC at billing width50228-0333Add 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
50228-333-01	5022803330150228033301	1 BOTTLE in 1 CARTON (50228-333-01) / 100 TABLET in 1 BOTTLEMarketed from Jul 28, 2023
50228-333-30	5022803333050228033330	1 BOTTLE in 1 CARTON (50228-333-30) / 30 TABLET in 1 BOTTLEMarketed from Jul 28, 2023

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 — 5 mg/1
Dosage form: Tablet
Route: Oral
Labeler: ScieGen Pharmaceuticals IncNDC labeler code 50228
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 213329
Marketing start: Jul 28, 2023
Listing expires: Dec 31, 2027
Other FDA classes: Increased Prothrombin Activity (Physiologic effect)Reversed Anticoagulation Activity (Physiologic effect)Vitamin K (Chemical structure)
Identifiers: Product ID 50228-333_02ae977c-f584-4433-e063-6394a90a1290SPL ID 02ae977c-f584-4433-e063-6394a90a1290SPL set ID c0e38a20-7225-46a5-9730-924cbd08dbeeRxCUI 198102UNII A034SE7857UPC 0350228333306, 0350228333016
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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N450228033301 followed by a unit qualifier and the quantity

Package 50228-0333-01. 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 Aug 11, 2023.

Indications (excerpt from the label)

Phytonadione is indicated for the treatment of adults with 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 caused by coumarin or indanedione derivatives; • hypoprothrombinemia secondary to antibacterial therapy; • hypoprothrombinemia secondary to factors limiting absorpsion or synthesis of vitamin K, e.g., obstructive jaundice, biliary fistula, sprue, ulcerative colitis, celiac disease, intestinal resection, cystic fibrosis of the pancrease, and regional enteritis; • Other drug-induced hypoprothrombinemia where it is defin…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 50228-333

What is NDC 50228-333?: 50228-333 is the product NDC for Phytonadione, Phytonadione 5 mg/1 tablet, listed with the FDA by ScieGen Pharmaceuticals Inc. It has 2 package NDCs, 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?: ScieGen Pharmaceuticals Inc, NDC labeler code 50228. 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?: 32 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 1 mg/.5mL	Injection, EmulsionIntramuscular, Intravenous, Subcutaneous	Dr.Reddys Laboratories Inc	43598-032	43598-0032-37
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

All 33 Phytonadione NDCs

Other NDCs under ANDA 213329

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

FDA NDC Directory listings under ANDA 213329
Product	Strength	Form · route	Labeler	Product NDC
Phytonadione	Phytonadione 5 mg/1	TabletOral	Cipla USA., Inc.	69097-999
Phytonadione	Phytonadione 5 mg/1	TabletOral	Exelan Pharmaceuticals, Inc.	76282-740