What is NDC 67046-1358?

67046-1358 is the product NDC for levofloxacin, Levofloxacin 500 mg/1 tablet, film coated, listed with the FDA by Coupler LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Coupler LLC, NDC labeler code 67046. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

levofloxacin NDC 67046-1358 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)67046-1358Labeler and product segments. Claims need a package NDC.

Product NDC at billing width67046-1358Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
67046-1358-3	6704613580367046135803	30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1358-3)Marketed from Aug 26, 2026

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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: Coupler LLCNDC labeler code 67046
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 077652
Marketing start: Aug 26, 2026
Listing expires: Dec 31, 2027
Identifiers: Product ID 67046-1358_59f385ac-1144-b978-e063-6294a90af9cdSPL ID 59f385ac-1144-b978-e063-6294a90af9cdSPL set ID 59f387a4-4dfa-ba71-e063-6294a90a340cRxCUI 199885UNII 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

N467046135803 followed by a unit qualifier and the quantity

Package 67046-1358-03. 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 Aug 26, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Levofloxacin is 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 Bronchitis ( 1.1…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 67046-1358

What is NDC 67046-1358?: 67046-1358 is the product NDC for levofloxacin, Levofloxacin 500 mg/1 tablet, film coated, listed with the FDA by Coupler LLC. It has 1 package NDC, 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?: Coupler LLC, NDC labeler code 67046. 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.

Other finished products listed under the same name: strengths, forms and labelers.

Other levofloxacin NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
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
Levofloxacin	Levofloxacin 25 mg/mL	SolutionOral	ANI Pharmaceuticals, Inc.	70954-852	70954-0852-1070954-0852-2070954-0852-30

All 124 levofloxacin NDCs

Other NDCs under ANDA 077652

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 077652
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	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	Zydus Lifesciences Limited	65841-693
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