Prescription drug · ANDA
Levofloxacin NDC 0143-9316
Levofloxacin 500 mg/100mL · Injection, Solution · Intravenous · Hikma Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0143-9316-24 | 00143931624 | 24 BAG in 1 CARTON (0143-9316-24) / 100 mL in 1 BAG (0143-9316-01)Marketed from Sep 16, 2011 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
- Active ingredients
- Levofloxacin — 500 mg/100mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091375
- Marketing start
- Listing expires
- Identifiers
- Product ID 0143-9316_05cdb9d7-2bce-400d-8565-8a76c4a1a8e3SPL ID 05cdb9d7-2bce-400d-8565-8a76c4a1a8e3SPL set ID f23c0df4-ae2a-446c-a9ba-dbbeb6ffaba5RxCUI 1665497, 1665507, 1665515UNII 6GNT3Y5LMF
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
N400143931624followed by a unit qualifier and the quantityPackage 00143-9316-24. 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 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 ( 1.4 ) a…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 091375
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 |
|---|---|---|---|---|
| Levofloxacin | Levofloxacin 250 mg/50mL | Injection, SolutionIntravenous | Hikma Pharmaceuticals USA Inc. | 0143-9315 |
| Levofloxacin | Levofloxacin 750 mg/150mL | Injection, SolutionIntravenous | Hikma Pharmaceuticals USA Inc. | 0143-9317 |
| Levofloxacin | Levofloxacin 750 mg/150mL | Injection, SolutionIntravenous | Hikma Pharmaceuticals USA Inc. | 0143-9720 |
| Levofloxacin | Levofloxacin 500 mg/100mL | Injection, SolutionIntravenous | Hikma Pharmaceuticals USA Inc. | 0143-9721 |
| Levofloxacin | Levofloxacin 250 mg/50mL | Injection, SolutionIntravenous | Hikma Pharmaceuticals USA Inc. | 0143-9722 |