Prescription drug · ANDA
Colistimethate (Colistimethate sodium) NDC 63323-393
Colistimethate sodium 150 mg/2mL · Injection, Powder, Lyophilized, For solution · Intramuscular, Intravenous · Fresenius Kabi USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63323-393-06 | 63323039306 | 1 VIAL in 1 BOX (63323-393-06) / 2 mL in 1 VIALMarketed from Dec 4, 2009 |
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)
- Colistimethate
- Generic name (nonproprietary)
- colistimethate sodium
- Active ingredients
- Colistimethate sodium — 150 mg/2mL
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intramuscular, Intravenous
- Labeler
- Fresenius Kabi USA, LLCNDC labeler code 63323
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 065364
- Marketing start
- Listing expires
- Other FDA classes
- Polymyxins (Chemical structure)
- Identifiers
- Product ID 63323-393_4637a207-5042-4af6-a7a7-e63cd472b0d3SPL ID 4637a207-5042-4af6-a7a7-e63cd472b0d3SPL set ID ab241809-0d2f-44ba-829c-26be67ee623fRxCUI 1117522UNII XW0E5YS77G
- 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
N463323039306followed by a unit qualifier and the quantityPackage 63323-0393-06. 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 .
Indications (excerpt from the label)
INDICATIONS AND USAGE Colistimethate for Injection, USP is indicated for the treatment of acute or chronic infections due to sensitive strains of certain gram-negative bacilli. It is particularly indicated when the infection is caused by sensitive strains of Pseudomonas aeruginosa . This antibiotic is not indicated for infections due to Proteus or Neisseria . Colistimethate for Injection, USP has proven clinically effective in treatment of infections due to the following gram-negative organisms: Enterobacter aerogenes, Escherichia coli, Klebsiella pneumoniae and Pseudomonas aeruginosa . Colistimethate for Injection, USP may be used to initiate therapy in serious infections that are suspected…
Excerpt only. Read the full label for complete information.
About NDC 63323-393
- What is NDC 63323-393?
- 63323-393 is the product NDC for Colistimethate (colistimethate sodium), Colistimethate sodium 150 mg/2mL 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?
- Colistimethate (Colistimethate sodium).
- What is the active ingredient?
- Colistimethate sodium.
- 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 Colistimethate?
- 2 other product NDCs are listed under this name. See all Colistimethate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Colistimethate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Colistimethatecolistimethate sodium | Colistimethate sodium 150 mg/1 | Injection, Powder, For solutionIntramuscular, Intravenous | Hikma Pharmaceuticals USA Inc. | 0143-9443 | 00143-9443-0100143-9443-12 |
| Colistimethatecolistimethate sodium | Colistimethate sodium 150 mg/1 | Injection, Powder, For solutionIntramuscular, Intravenous | Xellia Pharmaceuticals USA LLC | 70594-023 | 70594-0023-0170594-0023-04 |