Polymyxin B (polymyxin b sulfate) NDC 63323-367

NDC codes

FDA NDC Directory

Product NDC (as listed)63323-367Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63323-0367Add 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
63323-367-44	63323036744	10 VIAL, GLASS in 1 CARTON (63323-367-44) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS (63323-367-41)Marketed from Sep 9, 2015

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 sulfate
Active ingredients: Polymyxin b sulfate — 500000 [USP'U]/1
Dosage form: Injection, Powder, Lyophilized, For solution
Route: Intramuscular, Intrathecal, Intravenous
Labeler: Fresenius Kabi USA, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 202766
Marketing start: Sep 9, 2015
Listing expires: Dec 31, 2026
Other FDA classes: Polymyxins (Chemical structure)
Identifiers: Product ID 63323-367_5cf9b65b-6df4-42f8-b395-d0cf0a1003d3SPL ID 5cf9b65b-6df4-42f8-b395-d0cf0a1003d3SPL set ID 72dd6de6-31d6-4a8f-881b-91af91ed9314RxCUI 204509UNII 19371312D4
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

N463323036744 followed by a unit qualifier and the quantity

Package 63323-0367-44. 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 Dec 1, 2022. 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 blood-stream 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)

Other NDCs under ANDA 202766

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

FDA NDC Directory listings under ANDA 202766
Product	Strength	Form · route	Labeler	Product NDC
Polymyxin Bpolymyxin b sulfate	Polymyxin b sulfate 500000 [USP'U]/1	Injection, Powder, For solutionIntramuscular, Intrathecal, Intravenous, Ophthalmic	Xellia Pharmaceuticals USA LLC	70594-049
Polymyxin Bpolymyxin b sulfate	Polymyxin b sulfate 500000 [USP'U]/1	Injection, Powder, For solutionIntramuscular, Intrathecal, Intravenous, Ophthalmic	Hikma Pharmaceuticals USA Inc.	0143-9461