Prescription drug · ANDA
Levofloxacin NDC 71205-002
Levofloxacin 500 mg/1 · Tablet, Film coated · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71205-002-03 | 7120500020371205000203 | 3 TABLET, FILM COATED in 1 BOTTLE (71205-002-03)Marketed from Oct 22, 2020 | |
| 71205-002-05 | 7120500020571205000205 | 5 TABLET, FILM COATED in 1 BOTTLE (71205-002-05)Marketed from Apr 2, 2018 | |
| 71205-002-07 | 7120500020771205000207 | 7 TABLET, FILM COATED in 1 BOTTLE (71205-002-07)Marketed from Apr 2, 2018 | |
| 71205-002-10 | 7120500021071205000210 | 10 TABLET, FILM COATED in 1 BOTTLE (71205-002-10)Marketed from Apr 2, 2018 | |
| 71205-002-12 | 7120500021271205000212 | 12 TABLET, FILM COATED in 1 BOTTLE (71205-002-12)Marketed from Apr 1, 2019 | |
| 71205-002-14 | 7120500021471205000214 | 14 TABLET, FILM COATED in 1 BOTTLE (71205-002-14)Marketed from Apr 2, 2018 | |
| 71205-002-21 | 7120500022171205000221 | 21 TABLET, FILM COATED in 1 BOTTLE (71205-002-21)Marketed from Apr 2, 2018 |
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
- Proficient Rx LPNDC labeler code 71205
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202801
- Marketing start
- Listing expires
- Identifiers
- Product ID 71205-002_a630f88d-800c-400f-9da4-1b26c0ee1f85SPL ID a630f88d-800c-400f-9da4-1b26c0ee1f85SPL set ID 64141d0d-0347-470f-a427-9925a2eb357eRxCUI 199885UNII 6GNT3Y5LMFUPC 0371205002077
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
N471205000203followed by a unit qualifier and the quantityPackage 71205-0002-03. 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.
About NDC 71205-002
- What is NDC 71205-002?
- 71205-002 is the product NDC for Levofloxacin, Levofloxacin 500 mg/1 tablet, film coated, listed with the FDA by Proficient Rx LP. It has 7 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?
- Proficient Rx LP, NDC labeler code 71205. 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 250 mg/50mL | Injection, SolutionIntravenous | Hospira, Inc | 0409-2220 | 00409-2220-24 |
| 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 |
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 500 mg/1 | Tablet, Film coatedOral | ADVANCED RX PHARMACY OF TENNESSEE, LLC | 80425-0007 |
| Levofloxacin | Levofloxacin 750 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals, Inc. | 68788-8340 |
| Levofloxacin | Levofloxacin 750 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-833 |
| Levofloxacin | Levofloxacin 750 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-0593 |
| Levofloxacin | Levofloxacin 750 mg/1 | Tablet, Film coatedOral | Advanced Rx of Tennessee, LLC | 80425-0077 |
| Levofloxacin | Levofloxacin 750 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-3214 |
| Levofloxacin | Levofloxacin 250 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-3245 |
| Levofloxacin | Levofloxacin 250 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-0794 |
| Levofloxacin | Levofloxacin 750 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-1860 |
| Levofloxacin | Levofloxacin 500 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-3311 |
| Levofloxacin | Levofloxacin 500 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-3314 |
| Levofloxacin | Levofloxacin 500 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-0587 |
| Levofloxacin | Levofloxacin 500 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals, Inc. | 68788-6938 |
| Levofloxacin | Levofloxacin 500 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-3511 |
| Levofloxacin | Levofloxacin 750 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-2074 |
| Levofloxacin | Levofloxacin 750 mg/1 | Tablet, Film coatedOral | DirectRx | 72189-338 |
| Levofloxacin | Levofloxacin 250 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-0719 |
| Levofloxacin | Levofloxacin 500 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-4512 |
| Levofloxacin | Levofloxacin 250 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals, Inc. | 68071-3093 |
| Levofloxacin | Levofloxacin 500 mg/1 | Tablet, Film coatedOral | VERITYRX, LLC | 83939-0020 |
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