Moxifloxacin ophthalmic solution NDC 46708-505

NDC codes

FDA NDC Directory

Product NDC (as listed)46708-505Labeler and product segments. Claims need a package NDC.

Product NDC at billing width46708-0505Add 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
46708-505-03	46708050503	1 BOTTLE in 1 CARTON (46708-505-03) / 3 mL in 1 BOTTLEMarketed from Feb 13, 2019

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 ophthalmic solution
Generic name (nonproprietary): moxifloxacin ophthalmic solution
Active ingredients: Moxifloxacin hydrochloride — 5 mg/mL
Dosage form: Solution/ drops
Route: Ophthalmic
Labeler: Alembic Pharmaceuticals Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 209469
Marketing start: Feb 13, 2019
Listing expires: Dec 31, 2026
Other FDA classes: Fluoroquinolones (Chemical structure)
Identifiers: Product ID 46708-505_09d80c83-4b62-47a1-a3d7-6352bc6a79cdSPL ID 09d80c83-4b62-47a1-a3d7-6352bc6a79cdSPL set ID fee8323d-bcb0-4f49-a06d-2ed597a7b2acRxCUI 403818UNII C53598599T
Pharmacologic class: Fluoroquinolone Antibacterial

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

N446708050503 followed by a unit qualifier and the quantity

Package 46708-0505-03. 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 Apr 19, 2024.

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 influenzae 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 strain…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 209469

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

FDA NDC Directory listings under ANDA 209469
Product	Strength	Form · route	Labeler	Product NDC
Moxifloxacin ophthalmic solutionmoxifloxacin ophthalmic	Moxifloxacin hydrochloride 5 mg/mL	Solution/ dropsOphthalmic	A-S Medication Solutions	50090-4781
Moxifloxacin ophthalmic solution	Moxifloxacin hydrochloride 5 mg/mL	Solution/ dropsOphthalmic	Alembic Pharmaceuticals Inc.	62332-505