Prescription drug · ANDA
Levofloxacin NDC 76420-816
Levofloxacin 500 mg/1 · Tablet, Film coated · Oral · Asclemed USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76420-816-00 | 76420081600 | 1000 TABLET, FILM COATED in 1 BOTTLE (76420-816-00)Marketed from May 13, 2024 | |
| 76420-816-05 | 76420081605 | 5 TABLET, FILM COATED in 1 BOTTLE (76420-816-05)Marketed from May 13, 2024 | |
| 76420-816-07 | 76420081607 | 7 TABLET, FILM COATED in 1 BOTTLE (76420-816-07)Marketed from May 13, 2024 | |
| 76420-816-10 | 76420081610 | 10 TABLET, FILM COATED in 1 BOTTLE (76420-816-10)Marketed from May 13, 2024 | |
| 76420-816-14 | 76420081614 | 14 TABLET, FILM COATED in 1 BOTTLE (76420-816-14)Marketed from May 13, 2024 | |
| 76420-816-20 | 76420081620 | 20 TABLET, FILM COATED in 1 BOTTLE (76420-816-20)Marketed from May 13, 2024 | |
| 76420-816-30 | 76420081630 | 30 TABLET, FILM COATED in 1 BOTTLE (76420-816-30)Marketed from May 13, 2024 | |
| 76420-816-50 | 76420081650 | 50 TABLET, FILM COATED in 1 BOTTLE (76420-816-50)Marketed from May 13, 2024 | |
| 76420-816-60 | 76420081660 | 60 TABLET, FILM COATED in 1 BOTTLE (76420-816-60)Marketed from May 13, 2024 | |
| 76420-816-90 | 76420081690 | 90 TABLET, FILM COATED in 1 BOTTLE (76420-816-90)Marketed from May 13, 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 — 500 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Asclemed USA, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 201043
- Marketing start
- Listing expires
- Identifiers
- Product ID 76420-816_184fff28-0fd3-da61-e063-6294a90ac035SPL ID 184fff28-0fd3-da61-e063-6294a90ac035SPL set ID 2e32a8aa-047b-46c6-b67b-d88a9a0a810bRxCUI 199884, 199885, 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
N476420081600followed by a unit qualifier and the quantityPackage 76420-0816-00. 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 tablets are 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 Bronchit…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 201043
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 | HAWAII REPACK, INC. | 85534-0098 |
| Levofloxacin | Levofloxacin 250 mg/1 | Tablet, Film coatedOral | HAWAII REPACK, INC. | 85534-0096 |
| Levofloxacin | Levofloxacin 500 mg/1 | Tablet, Film coatedOral | HAWAII REPACK, INC. | 85534-0097 |
| Levofloxacin | Levofloxacin 250 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 71205-058 |
| Levofloxacin | Levofloxacin 500 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-085 |
| Levofloxacin | Levofloxacin 500 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-367 |
| Levofloxacin | Levofloxacin 500 mg/1 | Tablet, Film coatedOral | Advanced Rx of Tennessee, LLC | 80425-0008 |
| Levofloxacin | Levofloxacin 750 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 43063-459 |
| Levofloxacin | Levofloxacin 500 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 43063-457 |
| Levofloxacin | Levofloxacin 250 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-536 |
| Levofloxacin | Levofloxacin 250 mg/1 | Tablet, Film coatedOral | Asclemed USA, Inc. | 76420-815 |
| Levofloxacin | Levofloxacin 500 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-537 |
| Levofloxacin | Levofloxacin 750 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-538 |
| Levofloxacin | Levofloxacin 750 mg/1 | Tablet, Film coatedOral | Asclemed USA, Inc. | 76420-817 |
| Levofloxacin | Levofloxacin 250 mg/1 | Tablet, Film coatedOral | Redpharm Drug | 67296-1104 |
| Levofloxacin | Levofloxacin 500 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-3712 |