What is NDC 55111-280?

55111-280 is the product NDC for Levofloxacin, Levofloxacin 500 mg/1 tablet, film coated, listed with the FDA by Dr. Reddy's Laboratories Limited. It has 5 package NDCs, shown above in 10- and 11-digit form.

Dr. Reddy's Laboratories Limited, NDC labeler code 55111. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Levofloxacin NDC 55111-280 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)55111-280Labeler and product segments. Claims need a package NDC.

Product NDC at billing width55111-0280Add 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
55111-280-01	5511102800155111028001	100 TABLET, FILM COATED in 1 BOTTLE (55111-280-01)Marketed from Jun 20, 2011
55111-280-05	5511102800555111028005	500 TABLET, FILM COATED in 1 BOTTLE (55111-280-05)Marketed from Jun 20, 2011
55111-280-30	5511102803055111028030	30 TABLET, FILM COATED in 1 BOTTLE (55111-280-30)Marketed from Jun 20, 2011
55111-280-50	5511102805055111028050	50 TABLET, FILM COATED in 1 BOTTLE (55111-280-50)Marketed from Jun 20, 2011
55111-280-78	5511102807855111028078	10 BLISTER PACK in 1 CARTON (55111-280-78) / 10 TABLET, FILM COATED in 1 BLISTER PACK (55111-280-79)Marketed from Jun 20, 2011

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: Dr. Reddy's Laboratories LimitedNDC labeler code 55111
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 076710
Marketing start: Jun 20, 2011
Listing expires: Dec 31, 2027
Identifiers: Product ID 55111-280_c51f53eb-2f01-93dc-e7e6-695b20b639ceSPL ID c51f53eb-2f01-93dc-e7e6-695b20b639ceSPL set ID 9b59428a-a23a-b2d9-982f-98f8a1ed381fRxCUI 199884, 199885, 311296UNII 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

N455111028001 followed by a unit qualifier and the quantity

Package 55111-0280-01. 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 Jun 29, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

Levofloxacin tablet 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 Br…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 55111-280

What is NDC 55111-280?: 55111-280 is the product NDC for Levofloxacin, Levofloxacin 500 mg/1 tablet, film coated, listed with the FDA by Dr. Reddy's Laboratories 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?: Dr. Reddy's Laboratories Limited, NDC labeler code 55111. 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.

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	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

All 121 Levofloxacin NDCs

Other NDCs under ANDA 076710

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

FDA NDC Directory listings under ANDA 076710
Product	Strength	Form · route	Labeler	Product NDC
Levofloxacin	Levofloxacin 250 mg/1	Tablet, Film coatedOral	Major Pharmaceuticals	0904-6351
Levofloxacin	Levofloxacin 500 mg/1	Tablet, Film coatedOral	Major Pharmaceuticals	0904-6352
Levofloxacin	Levofloxacin 750 mg/1	Tablet, Film coatedOral	Major Pharmaceuticals	0904-6353
Levofloxacin	Levofloxacin 250 mg/1	Tablet, Film coatedOral	Golden State Medical Supply, Inc.	51407-428
Levofloxacin	Levofloxacin 500 mg/1	Tablet, Film coatedOral	Golden State Medical Supply, Inc.	51407-429
Levofloxacin	Levofloxacin 750 mg/1	Tablet, Film coatedOral	Golden State Medical Supply, Inc.	51407-430
Levofloxacin	Levofloxacin 750 mg/1	Tablet, Film coatedOral	Northwind Health Company, LLC	51655-327
Levofloxacin	Levofloxacin 500 mg/1	Tablet, Film coatedOral	Northwind Health Company, LLC	51655-666
Levofloxacin	Levofloxacin 250 mg/1	Tablet, Film coatedOral	Northwind Health Company, LLC	51655-947
Levofloxacin	Levofloxacin 250 mg/1	Tablet, Film coatedOral	Dr. Reddy's Laboratories Limited	55111-279
Levofloxacin	Levofloxacin 750 mg/1	Tablet, Film coatedOral	Dr. Reddy's Laboratories Limited	55111-281
Levofloxacin	Levofloxacin 500 mg/1	Tablet, Film coatedOral	Cardinal Health 107, LLC	55154-5897
Levofloxacin	Levofloxacin 750 mg/1	Tablet, Film coatedOral	Cardinal Health 107, LLC	55154-5898
Levofloxacin	Levofloxacin 500 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-0453
Levofloxacin	Levofloxacin 750 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-0932