Prescription drug · ANDA
Polymyxin B (polymyxin b sulfate) NDC 25021-196
Polymyxin b sulfate 500000 [USP'U]/1 · Injection, Powder, Lyophilized, For solution · Intramuscular, Intrathecal, Intravenous · Sagent Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 25021-196-10 | 25021019610 | 10 VIAL in 1 CARTON (25021-196-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIALMarketed from Oct 1, 2025 |
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
- Sagent Pharmaceuticals
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207322
- Marketing start
- Listing expires
- Other FDA classes
- Polymyxins (Chemical structure)
- Identifiers
- Product ID 25021-196_1d99f0e9-015c-4be1-b110-bdd156846dd1SPL ID 1d99f0e9-015c-4be1-b110-bdd156846dd1SPL set ID 7dc505aa-64b0-4b7f-8ee3-2945bde40a34RxCUI 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.
- NDC on a medical claim
N425021019610followed by a unit qualifier and the quantityPackage 25021-0196-10. 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.
Other NDCs under ANDA 207322
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Polymyxin Bpolymyxin b sulfate | Polymyxin b sulfate 500000 [USP'U]/1 | Injection, Powder, Lyophilized, For solutionIntramuscular, Intrathecal, Intravenous, Ophthalmic | Gland Pharma Limited | 68083-174 |
| Polymyxin Bpolymyxin b sulfate | Polymyxin b sulfate 500000 [USP'U]/1 | Injection, Powder, Lyophilized, For solutionIntramuscular, Intrathecal, Intravenous, Ophthalmic | FOSUN PHARMA USA INC | 72266-249 |