Prescription drug · ANDA

Levofloxacin NDC 55154-5898

Levofloxacin 750 mg/1 · Tablet, Film coated · Oral · Cardinal Health 107, LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)55154-5898Labeler and product segments. Claims need a package NDC.
Product NDC at billing width55154-5898Add 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 NDC11-digit (billing)PackageCopy
55154-5898-05515458980010 BLISTER PACK in 1 BAG (55154-5898-0) / 1 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Dec 1, 2013

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 — 750 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 076710
Marketing start
Listing expires
Identifiers
Product ID 55154-5898_0016fddf-e161-4304-8167-c723f838c454SPL ID 0016fddf-e161-4304-8167-c723f838c454SPL set ID 070375be-3b67-4299-ae8f-4a7b157ac16fRxCUI 199885, 311296UNII 6GNT3Y5LMFUPC 0055154589703

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

N455154589800 followed by a unit qualifier and the quantity

Package 55154-5898-00. 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 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)

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
ProductStrengthForm · routeLabelerProduct NDC
LevofloxacinLevofloxacin 500 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-0453
LevofloxacinLevofloxacin 750 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-0932
LevofloxacinLevofloxacin 250 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-6351
LevofloxacinLevofloxacin 750 mg/1Tablet, Film coatedOralDr. Reddy's Laboratories Limited55111-281
LevofloxacinLevofloxacin 500 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-6352
LevofloxacinLevofloxacin 250 mg/1Tablet, Film coatedOralDr. Reddy's Laboratories Limited55111-279
LevofloxacinLevofloxacin 500 mg/1Tablet, Film coatedOralDr. Reddy's Laboratories Limited55111-280
LevofloxacinLevofloxacin 500 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-666
LevofloxacinLevofloxacin 750 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-6353
LevofloxacinLevofloxacin 500 mg/1Tablet, Film coatedOralGolden State Medical Supply, Inc.51407-429
LevofloxacinLevofloxacin 250 mg/1Tablet, Film coatedOralGolden State Medical Supply, Inc.51407-428
LevofloxacinLevofloxacin 750 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-327
LevofloxacinLevofloxacin 750 mg/1Tablet, Film coatedOralGolden State Medical Supply, Inc.51407-430
LevofloxacinLevofloxacin 500 mg/1Tablet, Film coatedOralCardinal Health 107, LLC55154-5897
LevofloxacinLevofloxacin 250 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-947

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Levofloxacin NDC 55154-5898 | Med-Code