Prescription drug · ANDA
Levofloxacin NDC 80425-0077
Levofloxacin 750 mg/1 · Tablet, Film coated · Oral · Advanced Rx of Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80425-0077-1 | 80425007701 | 14 TABLET, FILM COATED in 1 BOTTLE (80425-0077-1)Marketed from Jan 9, 2015 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 750 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202801
- Marketing start
- Listing expires
- Identifiers
- Product ID 80425-0077_2a98d9c1-b778-40b1-e063-6294a90a20e4SPL ID 2a98d9c1-b778-40b1-e063-6294a90a20e4SPL set ID b001d60e-b8fb-54ff-e053-2a95a90a2970RxCUI 311296UNII 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 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
N480425007701followed by a unit qualifier and the quantityPackage 80425-0077-01. 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)
1. Indications and Usage Section 1 INDICATIONS & USAGE 1.1 Nosocomial Pneumonia Levofloxacin tablets are indicated in adult patients for the treatment of nosocomial pneumonia due to methicillin-susceptible Staphylococcus aureus, Pseudomonas aeruginosa, Serratia marcescens, Escherichia coli,Klebsiella pneumoniae, Haemophilus influenzae, or Streptococcus pneumoniae. Adjunctive therapy should be used as clinically indicated. Where Pseudomonas aeruginosa is a documented or presumptive pathogen, combination therapy with an anti-pseudomonal β-lactam is recommended [see Clinical Studies (14.1)]. 1.2 Community-Acquired Pneumonia: 7 to 14 day Treatment Regimen Levofloxacin tablets are indicated in ad…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 202801
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/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals, Inc. | 68071-3093 |
| Levofloxacin | Levofloxacin 250 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-3245 |
| Levofloxacin | Levofloxacin 750 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-1860 |
| Levofloxacin | Levofloxacin 500 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 71205-002 |
| Levofloxacin | Levofloxacin 500 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals, Inc. | 68788-6938 |
| Levofloxacin | Levofloxacin 500 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-0587 |
| Levofloxacin | Levofloxacin 500 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-4512 |
| Levofloxacin | Levofloxacin 750 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-2074 |
| Levofloxacin | Levofloxacin 250 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-0719 |
| Levofloxacin | Levofloxacin 750 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-3214 |
| Levofloxacin | Levofloxacin 500 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-3311 |
| Levofloxacin | Levofloxacin 750 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-3218 |
| Levofloxacin | Levofloxacin 500 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-0434 |
| Levofloxacin | Levofloxacin 500 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-3314 |
| Levofloxacin | Levofloxacin 750 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-0968 |
| Levofloxacin | Levofloxacin 750 mg/1 | Tablet, Film coatedOral | ST. MARY'S MEDICAL PARK PHARMACY | 60760-769 |
| Levofloxacin | Levofloxacin 500 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-4738 |
| Levofloxacin | Levofloxacin 500 mg/1 | Tablet, Film coatedOral | ADVANCED RX PHARMACY OF TENNESSEE, LLC | 80425-0007 |
| Levofloxacin | Levofloxacin 500 mg/1 | Tablet, Film coatedOral | VERITYRX, LLC | 83939-0020 |
| Levofloxacin | Levofloxacin 500 mg/1 | Tablet, Film coatedOral | DIRECT RX | 61919-426 |
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