Prescription drug · ANDA
Levofloxacin (Levofloxacin in 5% dextrose) NDC 55150-243
Levofloxacin 250 mg/50mL · Injection, Solution · Intravenous · Eugia US LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55150-243-46 | 5515002434655150024346 | 24 POUCH in 1 CARTON (55150-243-46) / 1 BAG in 1 POUCH / 50 mL in 1 BAGMarketed from Feb 10, 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)
- Levofloxacin
- Generic name (nonproprietary)
- levofloxacin in 5% dextrose
- Active ingredients
- Levofloxacin — 250 mg/50mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Eugia US LLCNDC labeler code 55150
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206919
- Marketing start
- Listing expires
- Identifiers
- Product ID 55150-243_8cb7f273-fc11-48e7-b2ef-a5290ab7ac4eSPL ID 8cb7f273-fc11-48e7-b2ef-a5290ab7ac4eSPL set ID 7d3f83bf-2db7-4657-9538-406adf321ad5RxCUI 1665497, 1665507, 1665515UNII 6GNT3Y5LMFUPC 0355150244478
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
N455150024346followed by a unit qualifier and the quantityPackage 55150-0243-46. 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)
Levofloxacin injection is indicated for the treatment of adults (≥18 years of age) with mild, moderate, and severe infections caused by susceptible isolates of the designated microorganisms in the conditions listed in this section. Levofloxacin injection is indicated when intravenous administration offers a route of administration advantageous to the patient (e.g., patient cannot tolerate an oral dosage form). Levofloxacin injection is a fluoroquinolone antibacterial indicated in adults (≥18 years of age) with infections caused by designated, susceptible bacteria ( 1 , 12.4 ). Pneumonia: Nosocomial ( 1.1 ) and Community Acquired (1.2 , 1.3) Skin and Skin Structure Infections: Complicated (1.…
Excerpt only. Read the full label for complete information.
About NDC 55150-243
- What is NDC 55150-243?
- 55150-243 is the product NDC for Levofloxacin (levofloxacin in 5% dextrose), Levofloxacin 250 mg/50mL injection, 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?
- Levofloxacin (Levofloxacin in 5% Dextrose).
- What is the active ingredient?
- Levofloxacin.
- 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 Levofloxacin?
- 120 other product NDCs are listed under this name. See all Levofloxacin NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Levofloxacin products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| levofloxacin | Levofloxacin 500 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1358 | 67046-1358-03 |
| levofloxacin | Levofloxacin 500 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4568 | 70518-4568-00 |
| levofloxacin | Levofloxacin 250 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1078 | 67046-1078-03 |
| levofloxacin | Levofloxacin 750 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc | 68788-8809 | 68788-8809-0168788-8809-0268788-8809-04+1 more |
| levofloxacin | Levofloxacin 500 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8772 | 68788-8772-0168788-8772-0268788-8772-03+2 more |
| Levofloxacinllevofloxacin | Levofloxacin 750 mg/1 | Tablet, Film coatedOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0388 | 80425-0388-0180425-0388-02 |
| Levofloxacin | Levofloxacin 250 mg/50mL | Injection, SolutionIntravenous | Hospira, Inc | 0409-2220 | 00409-2220-24 |
| Levofloxacin | Levofloxacin 500 mg/100mL | Injection, SolutionIntravenous | Hospira, Inc | 0409-3330 | 00409-3330-24 |
| Levofloxacin | Levofloxacin 750 mg/150mL | Injection, SolutionIntravenous | Hospira, Inc | 0409-4444 | 00409-4444-24 |
| Levofloxacin | Levofloxacin 25 mg/mL | SolutionOral | ANI Pharmaceuticals, Inc. | 70954-852 | 70954-0852-1070954-0852-2070954-0852-30 |
Other NDCs under ANDA 206919
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 |
|---|---|---|---|---|
| Levofloxacinlevofloxacin in 5% dextrose | Levofloxacin 500 mg/100mL | Injection, SolutionIntravenous | Eugia US LLC | 55150-244 |
| Levofloxacinlevofloxacin in 5% dextrose | Levofloxacin 750 mg/150mL | Injection, SolutionIntravenous | Eugia US LLC | 55150-245 |