Prescription drug · ANDA
Moxifloxacin NDC 82804-055
Moxifloxacin hydrochloride 5 mg/mL · Solution/ drops · Ophthalmic · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82804-055-03 | 82804005503 | 1 BOTTLE in 1 CARTON (82804-055-03) / 3 mL in 1 BOTTLEMarketed from Jan 9, 2024 |
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
- Proficient Rx LP
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206242
- Marketing start
- Listing expires
- Other FDA classes
- Fluoroquinolones (Chemical structure)
- Identifiers
- Product ID 82804-055_c38e051f-5765-4066-9953-2d0832481b1eSPL ID c38e051f-5765-4066-9953-2d0832481b1eSPL set ID c38e051f-5765-4066-9953-2d0832481b1eRxCUI 403818UNII C53598599TUPC 0382804055036
- 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
N482804005503followed by a unit qualifier and the quantityPackage 82804-0055-03. 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 .
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.
Other NDCs under ANDA 206242
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| 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 | NorthStar Rx LLC | 16714-643 |