What is NDC 69315-331?

69315-331 is the product NDC for Gatifloxacin, Gatifloxacin anhydrous 5 mg/mL solution, listed with the FDA by Leading Pharma, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Leading Pharma, LLC, NDC labeler code 69315. 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?

1 other product NDC are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Gatifloxacin NDC 69315-331 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)69315-331Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69315-0331Add 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
69315-331-02	69315033102	2.5 mL in 1 BOTTLE (69315-331-02)Marketed 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
Generic name (nonproprietary): gatifloxacin
Active ingredients: Gatifloxacin anhydrous — 5 mg/mL
Dosage form: Solution
Route: Ophthalmic
Labeler: Leading Pharma, LLCNDC labeler code 69315
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 69315-331_14b4bf1f-07ed-4578-96ac-47fc9c7c058bSPL ID 14b4bf1f-07ed-4578-96ac-47fc9c7c058bSPL set ID 826cf8c4-4be5-4614-bd42-47c1d0c9df58RxCUI 992395UNII 81485Y3A9AUPC 0369315331026
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

N469315033102 followed by a unit qualifier and the quantity

Package 69315-0331-02. 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 Oct 28, 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, Stre…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 69315-331

What is NDC 69315-331?: 69315-331 is the product NDC for Gatifloxacin, Gatifloxacin anhydrous 5 mg/mL solution, listed with the FDA by Leading Pharma, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Gatifloxacin.
What is the active ingredient?: Gatifloxacin anhydrous.
Who is the labeler?: Leading Pharma, LLC, NDC labeler code 69315. 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?: 1 other product NDC are listed under this name. See all Gatifloxacin 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 Gatifloxacin NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Gatifloxacin	Gatifloxacin 5 mg/mL	Solution/ dropsOphthalmic	Sandoz Inc	61314-672	61314-0672-25

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 Ophthalmic Solution 0.5%	Gatifloxacin anhydrous 5 mg/mL	SolutionOphthalmic	Caplin Steriles Limited	65145-207