Prescription drug · ANDA
Levofloxacin NDC 68071-1860
Levofloxacin 750 mg/1 · Tablet, Film coated · Oral · NuCare Pharmaceuticals,Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68071-1860-2 | 68071186002 | 20 TABLET, FILM COATED in 1 BOTTLE (68071-1860-2)Marketed from Mar 15, 2019 |
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
- Labeler
- NuCare Pharmaceuticals,Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202801
- Marketing start
- Listing expires
- Identifiers
- Product ID 68071-1860_2abbc9fa-1dc6-cbbc-e063-6294a90aa735SPL ID 2abbc9fa-1dc6-cbbc-e063-6294a90aa735SPL set ID 8423b021-e09c-4f1c-e053-2991aa0afef6RxCUI 311296UNII 6GNT3Y5LMFUPC 0368071186024
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
N468071186002followed by a unit qualifier and the quantityPackage 68071-1860-02. 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 is a fluoroquinolone antibacterial indicated in adults (18 years of age and older) with infections caused by designated, susceptible bacteria and in pediatric patients where indicated (1, 12.4). • Pneumonia: Nosocomial (1.1) and Community Acquired (1.2, 1.3) • Skin and Skin Structure Infections (SSSI): Complicated (1.4) and Uncomplicated (1.5) • Chronic bacterial prostatitis (1.6) • Inhalational Anthrax, Post-Exposure in adult and pediatric patients (1.7) • Plague in adult and pediatric patients (1.8) • Urinary Tract Infections (UTI): Complicated (1.9, 1.10) and Uncomplicated (1.12) • Acute Pyelonephritis (1.11) • Acute Bacterial Exacerbation of Chronic Bronchitis (1.13) • Acute…
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 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 |
| Levofloxacin | Levofloxacin 750 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-0593 |
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