Prescription drug · ANDA
Levofloxacin NDC 33342-533
Levofloxacin 750 mg/1 · Tablet, Film coated · Oral · Macleods Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 33342-533-11 | 3334205331133342053311 | 100 TABLET, FILM COATED in 1 BOTTLE (33342-533-11)Marketed from Mar 22, 2012 | |
| 33342-533-12 | 3334205331233342053312 | 100 TABLET, FILM COATED in 1 BLISTER PACK (33342-533-12)Marketed from Mar 22, 2012 | |
| 33342-533-31 | 3334205333133342053331 | 50 TABLET, FILM COATED in 1 BLISTER PACK (33342-533-31)Marketed from Mar 22, 2012 | |
| 33342-533-32 | 3334205333233342053332 | 20 TABLET, FILM COATED in 1 BOTTLE (33342-533-32)Marketed from Mar 22, 2012 |
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 — 750 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Macleods Pharmaceuticals LimitedNDC labeler code 33342
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 200839
- Marketing start
- Listing expires
- Identifiers
- Product ID 33342-533_fc165a6d-24b0-4753-a7ac-94a134dca0d3SPL ID fc165a6d-24b0-4753-a7ac-94a134dca0d3SPL set ID fc165a6d-24b0-4753-a7ac-94a134dca0d3RxCUI 199884, 199885, 311296UNII 6GNT3Y5LMFUPC 0333342533111, 0333342531087, 0333342532084, 0333342533326, 0333342531117, 0333342532114
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
N433342053311followed by a unit qualifier and the quantityPackage 33342-0533-11. 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 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 C…
Excerpt only. Read the full label for complete information.
About NDC 33342-533
- What is NDC 33342-533?
- 33342-533 is the product NDC for Levofloxacin, Levofloxacin 750 mg/1 tablet, film coated, listed with the FDA by Macleods Pharmaceuticals Limited. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Levofloxacin.
- What is the active ingredient?
- Levofloxacin.
- Who is the labeler?
- Macleods Pharmaceuticals Limited, NDC labeler code 33342. 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?
- 120 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 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 250 mg/50mL | Injection, SolutionIntravenous | Hospira, Inc | 0409-2220 | 00409-2220-24 |
| Levofloxacin | Levofloxacin 500 mg/100mL | Injection, SolutionIntravenous | Hospira, Inc | 0409-3330 | 00409-3330-24 |
| Levofloxacin | Levofloxacin 750 mg/150mL | Injection, SolutionIntravenous | Hospira, Inc | 0409-4444 | 00409-4444-24 |
| Levofloxacin | Levofloxacin 25 mg/mL | SolutionOral | ANI Pharmaceuticals, Inc. | 70954-852 | 70954-0852-1070954-0852-2070954-0852-30 |
Other NDCs under ANDA 200839
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 | Macleods Pharmaceuticals Limited | 33342-531 |
| Levofloxacin | Levofloxacin 500 mg/1 | Tablet, Film coatedOral | Macleods Pharmaceuticals Limited | 33342-532 |
| Levofloxacin | Levofloxacin 500 mg/1 | Tablet, Film coatedOral | Redpharm Drug | 67296-0743 |