Prescription drug · ANDA
Levofloxacin NDC 68180-240
Levofloxacin 250 mg/1 · Tablet, Film coated · Oral · Lupin Pharmaceuticals, Inc.
NDC codes
FDA NDC DirectoryProduct information
- Brand name (proprietary)
- Levofloxacin
- Generic name (nonproprietary)
- levofloxacin
- Active ingredients
- Levofloxacin — 250 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Lupin Pharmaceuticals, Inc.NDC labeler code 68180
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078424
- Marketing start
- Listing expires
- Identifiers
- Product ID 68180-240_04b864a6-b2f7-4e3d-aa12-32a501054b9cSPL ID 04b864a6-b2f7-4e3d-aa12-32a501054b9cSPL set ID 4be13bd5-0c39-43c3-9232-b1226ccd4dbcRxCUI 199884, 199885, 311296UNII 6GNT3Y5LMFUPC 0368180240013, 0368180240136
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.
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 )…
Excerpt only. Read the full label for complete information.
About NDC 68180-240
- What is NDC 68180-240?
- 68180-240 is the product NDC for Levofloxacin, Levofloxacin 250 mg/1 tablet, film coated, listed with the FDA by Lupin Pharmaceuticals, Inc..
- What drug is associated with this NDC?
- Levofloxacin.
- What is the active ingredient?
- Levofloxacin.
- Who is the labeler?
- Lupin Pharmaceuticals, Inc., NDC labeler code 68180. 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?
- 123 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 750 mg/1 | Tablet, Film coatedOral | St. Mary's Medical Park Pharmacy | 60760-769 | 60760-0769-10 |
| 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 750 mg/150mL | Injection, SolutionIntravenous | Hospira, Inc | 0409-4444 | 00409-4444-24 |
| Levofloxacin | Levofloxacin 500 mg/100mL | Injection, SolutionIntravenous | Hospira, Inc | 0409-3330 | 00409-3330-24 |
| Levofloxacin | Levofloxacin 250 mg/50mL | Injection, SolutionIntravenous | Hospira, Inc | 0409-2220 | 00409-2220-24 |
Other NDCs under ANDA 078424
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 500 mg/1 | Tablet, Film coatedOral | Lupin Pharmaceuticals, Inc. | 68180-241 |
| Levofloxacin | Levofloxacin 750 mg/1 | Tablet, Film coatedOral | Lupin Pharmaceuticals, Inc. | 68180-242 |