Prescription drug · ANDA
Levofloxacin NDC 63187-833
Levofloxacin 750 mg/1 · Tablet, Film coated · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63187-833-05 | 63187083305 | 5 TABLET, FILM COATED in 1 BOTTLE (63187-833-05)Marketed from May 1, 2017 | |
| 63187-833-07 | 63187083307 | 7 TABLET, FILM COATED in 1 BOTTLE (63187-833-07)Marketed from May 1, 2017 | |
| 63187-833-10 | 63187083310 | 10 TABLET, FILM COATED in 1 BOTTLE (63187-833-10)Marketed from May 1, 2017 | |
| 63187-833-30 | 63187083330 | 30 TABLET, FILM COATED in 1 BOTTLE (63187-833-30)Marketed from May 1, 2017 | |
| 63187-833-60 | 63187083360 | 60 TABLET, FILM COATED in 1 BOTTLE (63187-833-60)Marketed from May 1, 2017 | |
| 63187-833-90 | 63187083390 | 90 TABLET, FILM COATED in 1 BOTTLE (63187-833-90)Marketed from May 1, 2017 |
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
- Proficient Rx LP
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202801
- Marketing start
- Listing expires
- Identifiers
- Product ID 63187-833_e5c99469-b1e5-4f86-b4fa-7fcb4eac8f46SPL ID e5c99469-b1e5-4f86-b4fa-7fcb4eac8f46SPL set ID 95149cfb-1a71-42b7-b50d-9a2e94334339RxCUI 311296UNII 6GNT3Y5LMFUPC 0363187833077
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
N463187083305followed by a unit qualifier and the quantityPackage 63187-0833-05. 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 indicated for the treatment of adults (≥18 years of age) with mild, moderate, and severe infections caused by susceptible isolates of the designated microorganisms in the conditions listed in this section. Levofloxacin is a fluoroquinolone antibacterial indicated in adults (≥18 years of age) with infections caused by designated, susceptible bacteria ( 1 , 12.4 ). • Pneumonia: Nosocomial ( 1.1 ) and Community Acquired ( 1.2 , 1.3 ) • Skin and Skin Structure Infections: Complicated ( 1.4 ) and Uncomplicated ( 1.5 ) • Chronic bacterial prostatitis ( 1.6 ) • Inhalational Anthrax, Post-Exposure ( 1.7 ) • Plague ( 1.8 ) • Urinary Tract Infections: Complicated ( 1.9 , 1.10 …
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 750 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-1860 |
| 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 |
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