What is NDC 61314-672?

61314-672 is the product NDC for Gatifloxacin, Gatifloxacin 5 mg/mL solution/ drops, listed with the FDA by Sandoz Inc. It has 1 package NDC, shown above in 10- and 11-digit form.

Sandoz Inc, NDC labeler code 61314. 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 61314-672 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)61314-672Labeler and product segments. Claims need a package NDC.

Product NDC at billing width61314-0672Add 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
61314-672-25	61314067225	1 BOTTLE, DROPPER in 1 CARTON (61314-672-25) / 2.5 mL in 1 BOTTLE, DROPPERMarketed from Oct 3, 2016

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 — 5 mg/mL
Dosage form: Solution/ drops
Route: Ophthalmic
Labeler: Sandoz IncNDC labeler code 61314
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 204227
Marketing start: Oct 3, 2016
Listing expires: Dec 31, 2027
Other FDA classes: Quinolones (Chemical structure)
Identifiers: Product ID 61314-672_07c55058-89c9-4147-a026-e6c0b207efe3SPL ID 07c55058-89c9-4147-a026-e6c0b207efe3SPL set ID 9e6fcd14-1fee-493f-811c-e18cbfbee65bRxCUI 992395UNII L4618BD7KJ
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

N461314067225 followed by a unit qualifier and the quantity

Package 61314-0672-25. 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 Feb 15, 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 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, Strepto…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 61314-672

What is NDC 61314-672?: 61314-672 is the product NDC for Gatifloxacin, Gatifloxacin 5 mg/mL solution/ drops, listed with the FDA by Sandoz Inc. 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.
Who is the labeler?: Sandoz Inc, NDC labeler code 61314. 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 anhydrous 5 mg/mL	SolutionOphthalmic	Leading Pharma, LLC	69315-331	69315-0331-02