Prescription drug · ANDA
Levofloxacin NDC 70954-852
Levofloxacin 25 mg/mL · Solution · Oral · ANI Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70954-852-10 | 70954085210 | 100 mL in 1 BOTTLE (70954-852-10)Marketed from Mar 26, 2024 | |
| 70954-852-20 | 70954085220 | 200 mL in 1 BOTTLE (70954-852-20)Marketed from Mar 26, 2024 | |
| 70954-852-30 | 70954085230 | 480 mL in 1 BOTTLE (70954-852-30)Marketed from Mar 26, 2024 |
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
- Active ingredients
- Levofloxacin — 25 mg/mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- ANI Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091678
- Marketing start
- Listing expires
- Identifiers
- Product ID 70954-852_b548d9b8-70c9-41d4-8103-41568d50f561SPL ID b548d9b8-70c9-41d4-8103-41568d50f561SPL set ID a894e40b-77e4-439b-b0f8-9a5cc7a1dd90RxCUI 477391UNII 6GNT3Y5LMFUPC 0370954852308, 0370954852100
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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N470954085210followed by a unit qualifier and the quantityPackage 70954-0852-10. 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)
Levofloxacin oral solution 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 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) and Uncomplicated (1.5) Chronic bacterial prostatitis (1.6) Inhalational Anthrax, Post-Exposure (1.7) Plague (1.8) Urinary Tract Infections: Complicated (1.9, 1.10) and Uncomplicated (1.12) A…
Excerpt only. Read the full label for complete information.