What is NDC 0023-3615?

0023-3615 is the product NDC for Zymaxid (gatifloxacin), Gatifloxacin 5 mg/mL solution/ drops, listed with the FDA by Allergan, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.

Allergan, Inc., NDC labeler code 0023. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Zymaxid?

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.

Zymaxid NDC 0023-3615 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0023-3615Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00023-3615Add 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
0023-3615-01	00023361501	1 BOTTLE, DROPPER in 1 CARTON (0023-3615-01) / 1 mL in 1 BOTTLE, DROPPERMarketed from May 19, 2010 · Sample package
0023-3615-25	00023361525	1 BOTTLE, DROPPER in 1 CARTON (0023-3615-25) / 2.5 mL in 1 BOTTLE, DROPPERMarketed from May 19, 2010

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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): Zymaxid
Generic name (nonproprietary): gatifloxacin
Active ingredients: Gatifloxacin — 5 mg/mL
Dosage form: Solution/ drops
Route: Ophthalmic
Labeler: Allergan, Inc.NDC labeler code 0023
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 022548
Marketing start: May 19, 2010
Listing expires: Dec 31, 2027
Other FDA classes: Quinolones (Chemical structure)
Identifiers: Product ID 0023-3615_96056904-df3f-43e9-a3bd-8bb7d19eb49cSPL ID 96056904-df3f-43e9-a3bd-8bb7d19eb49cSPL set ID 1160b16c-929a-4e85-9c0b-1d8c96a7678bRxCUI 992395, 992399UNII 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

N400023361501 followed by a unit qualifier and the quantity

Package 00023-3615-01. 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 Sep 8, 2016.

Indications (excerpt from the label)

ZYMAXID ® 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 . ZYMAXID ® 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, Streptococcus mitis group , Streptococcus oralis, Streptococ…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0023-3615

What is NDC 0023-3615?: 0023-3615 is the product NDC for Zymaxid (gatifloxacin), Gatifloxacin 5 mg/mL solution/ drops, listed with the FDA by Allergan, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Zymaxid (Gatifloxacin).
What is the active ingredient?: Gatifloxacin.
Who is the labeler?: Allergan, Inc., NDC labeler code 0023. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Zymaxid?: 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.

Zymaxid (Gatifloxacin) NDC 0023-3615