What is NDC 65145-207?

65145-207 is the product NDC for Gatifloxacin Ophthalmic Solution 0.5%, Gatifloxacin anhydrous 5 mg/mL solution, listed with the FDA by Caplin Steriles Limited. It has 1 package NDC, shown above in 10- and 11-digit form.

Caplin Steriles Limited, NDC labeler code 65145. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Gatifloxacin Ophthalmic Solution 0.5%?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Gatifloxacin Ophthalmic Solution 0.5% NDC 65145-207

NDC codes

FDA NDC Directory

Product NDC (as listed)65145-207Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65145-0207Add 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
65145-207-01	65145020701	1 BOTTLE in 1 CARTON (65145-207-01) / 2.5 mL in 1 BOTTLEMarketed from Oct 6, 2025

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): Gatifloxacin Ophthalmic Solution 0.5%
Generic name (nonproprietary): gatifloxacin ophthalmic solution 0.5%
Active ingredients: Gatifloxacin anhydrous — 5 mg/mL
Dosage form: Solution
Route: Ophthalmic
Labeler: Caplin Steriles LimitedNDC labeler code 65145
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 213542
Marketing start: Oct 6, 2025
Listing expires: Dec 31, 2026
Other FDA classes: Quinolones (Chemical structure)
Identifiers: Product ID 65145-207_2dc44fc5-b7fc-40ec-8e9b-d86fae1fc523SPL ID 2dc44fc5-b7fc-40ec-8e9b-d86fae1fc523SPL set ID 2dc44fc5-b7fc-40ec-8e9b-d86fae1fc523RxCUI 992395UNII 81485Y3A9AUPC 0365145207012
Pharmacologic class: Quinolone Antimicrobial

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

N465145020701 followed by a unit qualifier and the quantity

Package 65145-0207-01. 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 6, 2025.

Indications (excerpt from the label)

Gatifloxacin ophthalmic solution 0.5 % is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms: Aerobic gram-positive bacteria: Staphylococcus aureus Staphylococcus epidermidis Streptococcus mitis group* Streptococcus oralis* Streptococcus pneumoniae Aerobic gram-negative bacteria: Haemophilus influenzae *Efficacy for these organisms were studied in fewer than 10 infections. Gatifloxacin ophthalmic solution 0.5 % is a quinolone antimicrobial indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms: Haemophilus influenzae, Staphylococcus aureus, Staphylococcus epidermidis, Strep…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 65145-207

What is NDC 65145-207?: 65145-207 is the product NDC for Gatifloxacin Ophthalmic Solution 0.5%, Gatifloxacin anhydrous 5 mg/mL solution, listed with the FDA by Caplin Steriles Limited. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Gatifloxacin Ophthalmic Solution 0.5%.
What is the active ingredient?: Gatifloxacin anhydrous.
Who is the labeler?: Caplin Steriles Limited, NDC labeler code 65145. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Gatifloxacin Ophthalmic Solution 0.5%?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other NDCs under ANDA 213542

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

FDA NDC Directory listings under ANDA 213542
Product	Strength	Form · route	Labeler	Product NDC
Gatifloxacin	Gatifloxacin anhydrous 5 mg/mL	SolutionOphthalmic	Leading Pharma, LLC	69315-331