Prescription drug · ANDA
Moxifloxacin NDC 80425-0379
Moxifloxacin hydrochloride monohydrate 5 mg/mL · Solution/ drops · Ophthalmic · Advanced Rx Pharmacy of Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80425-0379-1 | 80425037901 | 1 BOTTLE in 1 CARTON (80425-0379-1) / 3 mL in 1 BOTTLEMarketed from Mar 21, 2024 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 monohydrate — 5 mg/mL
- Dosage form
- Solution/ drops
- Route
- Ophthalmic
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202867
- Marketing start
- Listing expires
- Other FDA classes
- Fluoroquinolones (Chemical structure)
- Identifiers
- Product ID 80425-0379_14307586-424f-091a-e063-6394a90aee1fSPL ID 14307586-424f-091a-e063-6394a90aee1fSPL set ID 143075b4-24d4-08a1-e063-6394a90a8a6eRxCUI 403818UNII B8956S8609
- 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
N480425037901followed by a unit qualifier and the quantityPackage 80425-0379-01. 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 .
Indications (excerpt from the label)
Moxifloxacin ophthalmic solution, 0.5% is a topical fluoroquinolone anti- infective 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. ( 1 ) Moxifloxacin ophthalmic solution, 0.5% is indicated for the treatment of bacterial conjunctiviti…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 202867
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 | A-S Medication Solutions | 50090-6357 |
| Moxifloxacin | Moxifloxacin hydrochloride monohydrate 5 mg/mL | Solution/ dropsOphthalmic | Redpharm Drug | 67296-2129 |
| Moxifloxacin | Moxifloxacin hydrochloride monohydrate 5 mg/mL | Solution/ dropsOphthalmic | Direct Rx | 72189-321 |
| Moxifloxacin | Moxifloxacin hydrochloride monohydrate 5 mg/mL | Solution/ dropsOphthalmic | Lupin Pharmaceuticals, Inc. | 68180-422 |