Prescription drug · ANDA
Polymyxin B (Polymyxin b sulfate) NDC 63323-367
Polymyxin b sulfate 500000 [USP'U]/1 · Injection, Powder, Lyophilized, For solution · Intramuscular, Intrathecal, Intravenous · Fresenius Kabi USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63323-367-44 | 6332303674463323036744 | 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, LLCNDC labeler code 63323
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202766
- Marketing start
- Listing expires
- 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.
- NDC on a medical claim
N463323036744followed by a unit qualifier and the quantityPackage 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 . 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.
About NDC 63323-367
- What is NDC 63323-367?
- 63323-367 is the product NDC for Polymyxin B (polymyxin b sulfate), Polymyxin b sulfate 500000 [USP'U]/1 injection, powder, lyophilized, for solution, listed with the FDA by Fresenius Kabi USA, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Polymyxin B (Polymyxin B Sulfate).
- What is the active ingredient?
- Polymyxin b sulfate.
- Who is the labeler?
- Fresenius Kabi USA, LLC, NDC labeler code 63323. 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.
Related NDCs: other Polymyxin B products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Polymyxin Bpolymyxin b sulfate | Polymyxin b sulfate 500000 [USP'U]/1 | Injection, Powder, Lyophilized, For solutionIntramuscular, Intrathecal, Intravenous | Sagent Pharmaceuticals | 25021-196 | 25021-0196-10 |
| Polymyxin Bpolymyxin b sulfate | Polymyxin b sulfate 500000 [USP'U]/1 | Injection, Powder, For solutionIntramuscular, Intrathecal, Intravenous, Ophthalmic | Hikma Pharmaceuticals USA Inc. | 0143-9461 | 00143-9461-0100143-9461-10 |
| 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 | 72266-0249-10 |
| Polymyxin Bpolymyxin b sulfate | Polymyxin b sulfate 500000 [USP'U]/1 | Injection, Powder, For solutionIntramuscular, Intrathecal, Intravenous, Ophthalmic | Xellia Pharmaceuticals USA LLC | 70594-049 | 70594-0049-0170594-0049-02 |
| Polymyxin Bpolymyxin b sulfate | Polymyxin b sulfate 500000 [USP'U]/1 | Injection, Powder, Lyophilized, For solutionIntramuscular, Intrathecal, Intravenous, Ophthalmic | Gland Pharma Limited | 68083-174 | 68083-0174-10 |
| Polymyxin B | Polymyxin b sulfate 500000 [USP'U]/1 | Injection, Powder, Lyophilized, For solutionIntramuscular, Intrathecal, Intravenous, Ophthalmic | Eugia US LLC | 55150-234 | 55150-0234-10 |
| Polymyxin Bpolymyxin b sulfate | Polymyxin b sulfate 500000 [USP'U]/1 | Injection, Powder, Lyophilized, For solutionIntramuscular, Intrathecal, Intravenous, Ophthalmic | Fresenius Kabi USA, LLC | 63323-321 | 63323-0321-10 |
| Polymyxin Bpolymyxin b sulfate | Polymyxin b sulfate 500000 [iU]/1 | Injection, Powder, For solutionIntramuscular, Intrathecal, Intravenous, Ophthalmic | Hikma Pharmaceuticals USA Inc. | 0143-9941 | 00143-9941-10 |
Other NDCs under ANDA 202766
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, For solutionIntramuscular, Intrathecal, Intravenous, Ophthalmic | Hikma Pharmaceuticals USA Inc. | 0143-9461 |
| Polymyxin Bpolymyxin b sulfate | Polymyxin b sulfate 500000 [USP'U]/1 | Injection, Powder, For solutionIntramuscular, Intrathecal, Intravenous, Ophthalmic | Xellia Pharmaceuticals USA LLC | 70594-049 |