Prescription drug · ANDA

levofloxacin NDC 68788-8772

Levofloxacin 500 mg/1 · Tablet, Film coated · Oral · Preferred Pharmaceuticals Inc.

NDC codes

FDA NDC Directory
Product NDC (as listed)68788-8772Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68788-8772Add 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
68788-8772-16878887720110 TABLET, FILM COATED in 1 BOTTLE (68788-8772-1)Marketed from Nov 20, 2024
68788-8772-26878887720220 TABLET, FILM COATED in 1 BOTTLE (68788-8772-2)Marketed from Nov 20, 2024
68788-8772-36878887720330 TABLET, FILM COATED in 1 BOTTLE (68788-8772-3)Marketed from Nov 20, 2024
68788-8772-46878887720414 TABLET, FILM COATED in 1 BOTTLE (68788-8772-4)Marketed from Nov 20, 2024
68788-8772-7687888772077 TABLET, FILM COATED in 1 BOTTLE (68788-8772-7)Marketed from Nov 20, 2024

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
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 077652
Marketing start
Listing expires
Identifiers
Product ID 68788-8772_6c2423aa-8cfa-481f-97f6-ed4b6f8d0ee6SPL ID 6c2423aa-8cfa-481f-97f6-ed4b6f8d0ee6SPL set ID 7a12135e-cbad-4fe1-98f7-53c41d1f2a21RxCUI 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

N468788877201 followed by a unit qualifier and the quantity

Package 68788-8772-01. 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 . 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 , ). • Pneumonia: Nosocomial () and Community Acquired (,) • Skin and Skin Structure Infections (SSSI): Complicated () and Uncomplicated () • Chronic bacterial prostatitis () • Inhalational Anthrax, Post-Exposure in adult and pediatric patients () • Plague in adult and pediatric patients () • Urinary Tract Infections (UTI): Complicated (, ) and Uncomplicated () • Acute Pyelonephritis () • Acute Bacterial Exacerbation of Chronic Bronchitis () • Acute Bacterial Sinusitis () Usage To reduce the de…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

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
ProductStrengthForm · routeLabelerProduct NDC
levofloxacinLevofloxacin 750 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc68788-8809
levofloxacinLevofloxacin 250 mg/1Tablet, Film coatedOralZydus Lifesciences Limited65841-691
levofloxacinLevofloxacin 500 mg/1Tablet, Film coatedOralRedpharm Drug67296-2126
levofloxacinLevofloxacin 500 mg/1Tablet, Film coatedOralZydus Lifesciences Limited65841-692
levofloxacinLevofloxacin 750 mg/1Tablet, Film coatedOralZydus Lifesciences Limited65841-693
levofloxacinLevofloxacin 250 mg/1Tablet, Film coatedOralViona Pharmaceuticals Inc72578-098
levofloxacinLevofloxacin 500 mg/1Tablet, Film coatedOralViona Pharmaceuticals Inc72578-099
levofloxacinLevofloxacin 750 mg/1Tablet, Film coatedOralViona Pharmaceuticals Inc72578-100
levofloxacinLevofloxacin 750 mg/1Tablet, Film coatedOralRedpharm Drug67296-2187
levofloxacinLevofloxacin 250 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-3173
levofloxacinLevofloxacin 500 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-4568
levofloxacinLevofloxacin 250 mg/1Tablet, Film coatedOralRedpharm Drug67296-2242
levofloxacinLevofloxacin 750 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-2265
levofloxacinLevofloxacin 500 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-2276
levofloxacinLevofloxacin 250 mg/1Tablet, Film coatedOralCoupler LLC67046-1078
LevofloxacinllevofloxacinLevofloxacin 750 mg/1Tablet, Film coatedOralAdvanced Rx Pharmacy of Tennessee, LLC80425-0388
levofloxacinLevofloxacin 500 mg/1Tablet, Film coatedOralCoupler LLC67046-1358

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