Prescription drug · ANDA
levofloxacin NDC 65841-693
Levofloxacin 750 mg/1 · Tablet, Film coated · Oral · Zydus Lifesciences Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65841-693-01 | 6584106930165841069301 | 100 TABLET, FILM COATED in 1 BOTTLE (65841-693-01)Marketed from Nov 10, 2012 | |
| 65841-693-05 | 6584106930565841069305 | 500 TABLET, FILM COATED in 1 BOTTLE (65841-693-05)Marketed from Nov 10, 2012 | |
| 65841-693-06 | 6584106930665841069306 | 30 TABLET, FILM COATED in 1 BOTTLE (65841-693-06)Marketed from Jan 10, 2022 | |
| 65841-693-18 | 6584106931865841069318 | 50 TABLET, FILM COATED in 1 BOTTLE (65841-693-18)Marketed from Nov 10, 2012 | |
| 65841-693-92 | 6584106939265841069392 | 20 TABLET, FILM COATED in 1 BOTTLE (65841-693-92)Marketed from Jan 10, 2022 |
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
- Zydus Lifesciences LimitedNDC labeler code 65841
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077652
- Marketing start
- Listing expires
- Identifiers
- Product ID 65841-693_5aeae448-e53f-4954-9dd9-2bcc3dd791d4SPL ID 5aeae448-e53f-4954-9dd9-2bcc3dd791d4SPL set ID ffa121b8-388f-4d7b-af48-d4aa8d9b5961RxCUI 199884, 199885, 311296UNII 6GNT3Y5LMFUPC 0372578100063
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
N465841069301followed by a unit qualifier and the quantityPackage 65841-0693-01. 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 .
About NDC 65841-693
- What is NDC 65841-693?
- 65841-693 is the product NDC for levofloxacin, Levofloxacin 750 mg/1 tablet, film coated, listed with the FDA by Zydus Lifesciences Limited. It has 5 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?
- Zydus Lifesciences Limited, NDC labeler code 65841. 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 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 250 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-594 |
| levofloxacin | Levofloxacin 250 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-3173 |
| levofloxacin | Levofloxacin 250 mg/1 | Tablet, Film coatedOral | Redpharm Drug | 67296-2242 |
| levofloxacin | Levofloxacin 250 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1078 |
| levofloxacin | Levofloxacin 750 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2265 |
| levofloxacin | Levofloxacin 500 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1358 |
| levofloxacin | Levofloxacin 500 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2276 |
| levofloxacin | Levofloxacin 500 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8772 |
| Levofloxacinllevofloxacin | Levofloxacin 750 mg/1 | Tablet, Film coatedOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0388 |
| levofloxacin | Levofloxacin 500 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 65841-692 |
| levofloxacin | Levofloxacin 250 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 65841-691 |
| levofloxacin | Levofloxacin 750 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc | 68788-8809 |
| levofloxacin | Levofloxacin 500 mg/1 | Tablet, Film coatedOral | Redpharm Drug | 67296-2126 |
| levofloxacin | Levofloxacin 750 mg/1 | Tablet, Film coatedOral | Redpharm Drug | 67296-2187 |
| levofloxacin | Levofloxacin 250 mg/1 | Tablet, Film coatedOral | Viona Pharmaceuticals Inc | 72578-098 |
| levofloxacin | Levofloxacin 500 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4568 |
| 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 |