NDC codes

FDA NDC Directory
Product NDC (as listed)55150-234Labeler and product segments. Claims need a package NDC.
Product NDC at billing width55150-0234Add 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
55150-234-105515002341010 VIAL in 1 CARTON (55150-234-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIALMarketed from Apr 4, 2016

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)
Polymyxin B
Generic name (nonproprietary)
polymyxin b
Active ingredients
Polymyxin b sulfate — 500000 [USP'U]/1
Dosage form
Injection, Powder, Lyophilized, For solution
Route
Intramuscular, Intrathecal, Intravenous, Ophthalmic
Labeler
Eugia US LLCNDC labeler code 55150
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 206589
Marketing start
Listing expires
Other FDA classes
Polymyxins (Chemical structure)
Identifiers
Product ID 55150-234_097fa44b-506b-4ee0-9f64-4b560c3ed41cSPL ID 097fa44b-506b-4ee0-9f64-4b560c3ed41cSPL set ID a974c557-e88f-451b-a1bd-d2c656be226eRxCUI 204509UNII 19371312D4UPC 0355150234103
Pharmacologic class
Polymyxin-class Antibacterial

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

N455150023410 followed by a unit qualifier and the quantity

Package 55150-0234-10. 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)

INDICATIONS AND USAGE Acute Infections Caused by Susceptible Strains of Pseudomonas aeruginosa. Polymyxin B sulfate is a drug of choice in the treatment of infections of the urinary tract, meninges, and bloodstream caused by susceptible strains of Ps. aeruginosa . It may also be used topically and subconjunctivally in the treatment of infections of the eye caused by susceptible strains of Ps. aeruginosa . It may be indicated in serious infections caused by susceptible strains of the following organisms, when less potentially toxic drugs are ineffective or contraindicated: H influenzae , specifically meningeal infections. Escherichia coli , specifically urinary tract infections. Aerobacter ae…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 55150-234

What is NDC 55150-234?
55150-234 is the product NDC for Polymyxin B, Polymyxin b sulfate 500000 [USP'U]/1 injection, powder, lyophilized, for solution, listed with the FDA by Eugia US LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Polymyxin B.
What is the active ingredient?
Polymyxin b sulfate.
Who is the labeler?
Eugia US LLC, NDC labeler code 55150. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Polymyxin B?
8 other product NDCs are listed under this name. See all Polymyxin B 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 Polymyxin B NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Polymyxin Bpolymyxin b sulfatePolymyxin b sulfate 500000 [USP'U]/1Injection, Powder, Lyophilized, For solutionIntramuscular, Intrathecal, IntravenousSagent Pharmaceuticals25021-19625021-0196-10
Polymyxin Bpolymyxin b sulfatePolymyxin b sulfate 500000 [USP'U]/1Injection, Powder, For solutionIntramuscular, Intrathecal, Intravenous, OphthalmicHikma Pharmaceuticals USA Inc.0143-946100143-9461-0100143-9461-10
Polymyxin Bpolymyxin b sulfatePolymyxin b sulfate 500000 [USP'U]/1Injection, Powder, Lyophilized, For solutionIntramuscular, Intrathecal, Intravenous, OphthalmicFOSUN PHARMA USA INC72266-24972266-0249-10
Polymyxin Bpolymyxin b sulfatePolymyxin b sulfate 500000 [USP'U]/1Injection, Powder, For solutionIntramuscular, Intrathecal, Intravenous, OphthalmicXellia Pharmaceuticals USA LLC70594-04970594-0049-0170594-0049-02
Polymyxin Bpolymyxin b sulfatePolymyxin b sulfate 500000 [USP'U]/1Injection, Powder, Lyophilized, For solutionIntramuscular, Intrathecal, Intravenous, OphthalmicGland Pharma Limited68083-17468083-0174-10
Polymyxin Bpolymyxin b sulfatePolymyxin b sulfate 500000 [USP'U]/1Injection, Powder, Lyophilized, For solutionIntramuscular, Intrathecal, IntravenousFresenius Kabi USA, LLC63323-36763323-0367-44
Polymyxin Bpolymyxin b sulfatePolymyxin b sulfate 500000 [USP'U]/1Injection, Powder, Lyophilized, For solutionIntramuscular, Intrathecal, Intravenous, OphthalmicFresenius Kabi USA, LLC63323-32163323-0321-10
Polymyxin Bpolymyxin b sulfatePolymyxin b sulfate 500000 [iU]/1Injection, Powder, For solutionIntramuscular, Intrathecal, Intravenous, OphthalmicHikma Pharmaceuticals USA Inc.0143-994100143-9941-10

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