Prescription drug · ANDA
levofloxacin NDC 71335-2265
Levofloxacin 750 mg/1 · Tablet, Film coated · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-2265-0 | 71335226500 | 3 TABLET, FILM COATED in 1 BOTTLE (71335-2265-0)Marketed from Jul 25, 2024 | |
| 71335-2265-1 | 71335226501 | 10 TABLET, FILM COATED in 1 BOTTLE (71335-2265-1)Marketed from Nov 27, 2023 | |
| 71335-2265-2 | 71335226502 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-2265-2)Marketed from Dec 6, 2023 | |
| 71335-2265-3 | 71335226503 | 7 TABLET, FILM COATED in 1 BOTTLE (71335-2265-3)Marketed from Oct 24, 2023 | |
| 71335-2265-4 | 71335226504 | 20 TABLET, FILM COATED in 1 BOTTLE (71335-2265-4)Marketed from Apr 15, 2024 | |
| 71335-2265-5 | 71335226505 | 5 TABLET, FILM COATED in 1 BOTTLE (71335-2265-5)Marketed from Nov 7, 2023 | |
| 71335-2265-6 | 71335226506 | 14 TABLET, FILM COATED in 1 BOTTLE (71335-2265-6)Marketed from Jan 17, 2024 | |
| 71335-2265-7 | 71335226507 | 28 TABLET, FILM COATED in 1 BOTTLE (71335-2265-7)Marketed from Jul 25, 2024 | |
| 71335-2265-8 | 71335226508 | 60 TABLET, FILM COATED in 1 BOTTLE (71335-2265-8)Marketed from Jul 25, 2024 | |
| 71335-2265-9 | 71335226509 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-2265-9)Marketed from Jul 25, 2024 |
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
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077652
- Marketing start
- Listing expires
- Identifiers
- Product ID 71335-2265_477d7d9e-1637-4c49-b588-f1da546a67f0SPL ID 477d7d9e-1637-4c49-b588-f1da546a67f0SPL set ID cbd5153f-fada-4682-b858-dc3b6e3173ccRxCUI 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
N471335226500followed by a unit qualifier and the quantityPackage 71335-2265-00. 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 ( 1.1…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 077652
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 750 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc | 68788-8809 |
| levofloxacin | Levofloxacin 500 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8772 |
| levofloxacin | Levofloxacin 250 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 65841-691 |
| levofloxacin | Levofloxacin 500 mg/1 | Tablet, Film coatedOral | Redpharm Drug | 67296-2126 |
| levofloxacin | Levofloxacin 500 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 65841-692 |
| levofloxacin | Levofloxacin 750 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 65841-693 |
| levofloxacin | Levofloxacin 250 mg/1 | Tablet, Film coatedOral | Viona Pharmaceuticals Inc | 72578-098 |
| levofloxacin | Levofloxacin 500 mg/1 | Tablet, Film coatedOral | Viona Pharmaceuticals Inc | 72578-099 |
| levofloxacin | Levofloxacin 750 mg/1 | Tablet, Film coatedOral | Viona Pharmaceuticals Inc | 72578-100 |
| levofloxacin | Levofloxacin 750 mg/1 | Tablet, Film coatedOral | Redpharm Drug | 67296-2187 |
| levofloxacin | Levofloxacin 250 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-3173 |
| levofloxacin | Levofloxacin 500 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4568 |
| levofloxacin | Levofloxacin 250 mg/1 | Tablet, Film coatedOral | Redpharm Drug | 67296-2242 |
| levofloxacin | Levofloxacin 500 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2276 |
| levofloxacin | Levofloxacin 250 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1078 |
| Levofloxacinllevofloxacin | Levofloxacin 750 mg/1 | Tablet, Film coatedOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0388 |
| levofloxacin | Levofloxacin 500 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1358 |