NDC codes

FDA NDC Directory
Product NDC (as listed)54288-140Labeler and product segments. Claims need a package NDC.
Product NDC at billing width54288-0140Add 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
54288-140-0154288014001542880140011 CARTON in 1 CARTON (54288-140-01) / 5 mL in 1 CARTONMarketed from Jul 13, 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 — 15 mg/mL
Dosage form
Solution/ drops
Route
Ophthalmic
Labeler
BPI LABS LLCNDC labeler code 54288
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 205600
Marketing start
Listing expires
Identifiers
Product ID 54288-140_4c9a6374-9e83-420d-bc29-20170bfbc6e1SPL ID 4c9a6374-9e83-420d-bc29-20170bfbc6e1SPL set ID b6d9740b-2f9d-4f1c-bc9b-4c2150b22f10RxCUI 545118UNII 6GNT3Y5LMFUPC 0354288140010

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. Ophthalmic products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N454288014001 followed by a unit qualifier and the quantity

Package 54288-0140-01. 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 .

Indications (excerpt from the label)

Levofloxacin ophthalmic solution is indicated for the treatment of corneal ulcer caused by susceptible strains of the following bacteria: Gram-positive bacteria: Corynebacterium species Staphylococcus aureus Staphylococcus epidermidis Streptococcus pneumonia Viridans group streptococci* Gram-negative bacteria: Pseudomonas aeruginosa Serratia marcescens* *Efficacy for this organism was studied in fewer than 10 infections Levofloxacin ophthalmic solution is a topical quinolone anti-microbial indicated for the treatment of corneal ulcer caused by susceptible strains of the following bacteria: Corynebacterium species * Staphylococcus aureus Staphylococcus epidermidis Streptococcus pneumonia Viri…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 54288-140

What is NDC 54288-140?
54288-140 is the product NDC for Levofloxacin, Levofloxacin 15 mg/mL solution/ drops, listed with the FDA by BPI LABS 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?
BPI LABS LLC, NDC labeler code 54288. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
levofloxacinLevofloxacin 500 mg/1Tablet, Film coatedOralCoupler LLC67046-135867046-1358-03
levofloxacinLevofloxacin 500 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-456870518-4568-00
levofloxacinLevofloxacin 250 mg/1Tablet, Film coatedOralCoupler LLC67046-107867046-1078-03
levofloxacinLevofloxacin 750 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc68788-880968788-8809-0168788-8809-0268788-8809-04+1 more
levofloxacinLevofloxacin 500 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-877268788-8772-0168788-8772-0268788-8772-03+2 more
LevofloxacinllevofloxacinLevofloxacin 750 mg/1Tablet, Film coatedOralAdvanced Rx Pharmacy of Tennessee, LLC80425-038880425-0388-0180425-0388-02
LevofloxacinLevofloxacin 250 mg/50mLInjection, SolutionIntravenousHospira, Inc0409-222000409-2220-24
LevofloxacinLevofloxacin 500 mg/100mLInjection, SolutionIntravenousHospira, Inc0409-333000409-3330-24
LevofloxacinLevofloxacin 750 mg/150mLInjection, SolutionIntravenousHospira, Inc0409-444400409-4444-24
LevofloxacinLevofloxacin 25 mg/mLSolutionOralANI Pharmaceuticals, Inc.70954-85270954-0852-1070954-0852-2070954-0852-30

All 121 Levofloxacin NDCs

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