Moxifloxacin NDC 16714-643

NDC codes

FDA NDC Directory

Product NDC (as listed)16714-643Labeler and product segments. Claims need a package NDC.

Product NDC at billing width16714-0643Add 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
16714-643-01	16714064301	1 BOTTLE in 1 CARTON (16714-643-01) / 3 mL in 1 BOTTLEMarketed from Oct 4, 2017

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): Moxifloxacin
Generic name (nonproprietary): moxifloxacin
Active ingredients: Moxifloxacin hydrochloride — 5 mg/mL
Dosage form: Solution/ drops
Route: Ophthalmic
Labeler: NorthStar Rx LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 206242
Marketing start: Oct 4, 2017
Listing expires: Dec 31, 2026
Other FDA classes: Quinolones (Chemical structure)
Identifiers: Product ID 16714-643_c11c970c-ffa6-4661-b515-708bae4eddd6SPL ID c11c970c-ffa6-4661-b515-708bae4eddd6SPL set ID cdc0b0eb-5f56-45c7-b9fd-364752a95ff1RxCUI 403818UNII C53598599T
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

N416714064301 followed by a unit qualifier and the quantity

Package 16714-0643-01. 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 Dec 28, 2022.

Indications (excerpt from the label)

Moxifloxacin ophthalmic solution is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms: Corynebacterium species* Micrococcus luteus* Staphylococcus aureus Staphylococcus epidermidis Staphylococcus haemolyticus Staphylococcus hominis Staphylococcus warneri* Streptococcus pneumoniae Streptococcus viridans group Acinetobacter lwoffii* Haemophilus influenza Haemophilus parainfluenzae* Chlamydia trachomatis *Efficacy for this organism was studied in fewer than 10 infections. Moxifloxacin ophthalmic solution is a topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis caused by susceptible strains …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 206242

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

FDA NDC Directory listings under ANDA 206242
Product	Strength	Form · route	Labeler	Product NDC
Moxifloxacin	Moxifloxacin hydrochloride 5 mg/mL	Solution/ dropsOphthalmic	Aurobindo Pharma Limited	65862-840
Moxifloxacin	Moxifloxacin hydrochloride 5 mg/mL	Solution/ dropsOphthalmic	A-S Medication Solutions	50090-8029
Moxifloxacin	Moxifloxacin hydrochloride 5 mg/mL	Solution/ dropsOphthalmic	Proficient Rx LP	82804-055