Levofloxacin NDC 68083-414

NDC codes

FDA NDC Directory

Product NDC (as listed)68083-414Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68083-0414Add 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
68083-414-01	68083041401	1 BAG in 1 POUCH (68083-414-01) / 50 mL in 1 BAGMarketed from Dec 30, 2020

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 — 250 mg/50mL
Dosage form: Injection, Solution
Route: Intravenous
Labeler: Gland Pharma Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 206908
Marketing start: Dec 30, 2020
Listing expires: Dec 31, 2026
Identifiers: Product ID 68083-414_7df12e53-0519-4d42-b89f-dbe83b7e7e7dSPL ID 7df12e53-0519-4d42-b89f-dbe83b7e7e7dSPL set ID 95479f18-76dc-41cf-a359-922febeed0f2RxCUI 1665497, 1665507, 1665515UNII 6GNT3Y5LMFUPC 0368083414016, 0368083416010, 0368083415013

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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N468083041401 followed by a unit qualifier and the quantity

Package 68083-0414-01. 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 Jul 3, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

Levofloxacin Injection is indicated for the treatment of adults (≥18 years of age) with mild, moderate, and severe infections caused by susceptible isolates of the designated microorganisms in the conditions listed in this section. Levofloxacin Injection is indicated when intravenous administration offers a route of administration advantageous to the patient (e.g., patient cannot tolerate an oral dosage form). Levofloxacin is a fluoroquinolone antibacterial indicated in adults (≥18 years of age) with infections caused by designated, susceptible bacteria ( 1 , 12.4 ). • Pneumonia: Nosocomial ( 1.1 ) and Community Acquired ( 1.2 , 1.3 ) • Skin and Skin Structure Infections: Complicated ( 1.4 )…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 206908

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

FDA NDC Directory listings under ANDA 206908
Product	Strength	Form · route	Labeler	Product NDC
levofloxacin	Levofloxacin 750 mg/150mL	Injection, SolutionIntravenous	Gland Pharma Limited	68083-416
levofloxacin	Levofloxacin 500 mg/100mL	Injection, SolutionIntravenous	Gland Pharma Limited	68083-415