Prescription drug · ANDA
Moxifloxacin Hydrochloride NDC 76420-331
Moxifloxacin hydrochloride 5 mg/mL · Solution · Ophthalmic · Asclemed USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76420-331-03 | 7642003310376420033103 | 1 BOTTLE, PLASTIC in 1 CARTON (76420-331-03) / 3 mL in 1 BOTTLE, PLASTICMarketed from Apr 19, 2025 |
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 Hydrochloride
- Generic name (nonproprietary)
- moxifloxacin hydrochloride
- Active ingredients
- Moxifloxacin hydrochloride — 5 mg/mL
- Dosage form
- Solution
- Route
- Ophthalmic
- Labeler
- Asclemed USA, Inc.NDC labeler code 76420
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212616
- Marketing start
- Listing expires
- Other FDA classes
- Fluoroquinolones (Chemical structure)
- Identifiers
- Product ID 76420-331_331b69c5-5ad7-a90a-e063-6394a90acfd6SPL ID 331b69c5-5ad7-a90a-e063-6394a90acfd6SPL set ID 8f92f110-32d6-4d0c-a415-7a9a4cafb9b8RxCUI 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
N476420033103followed by a unit qualifier and the quantityPackage 76420-0331-03. 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 Efficacy for this organism was studied in fewer than 10 infections. 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 Moxifloxacin ophthalmic solution is a topical fluoroquinolone anti- infective indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of th…
Excerpt only. Read the full label for complete information.
About NDC 76420-331
- What is NDC 76420-331?
- 76420-331 is the product NDC for Moxifloxacin Hydrochloride, Moxifloxacin hydrochloride 5 mg/mL solution, listed with the FDA by Asclemed USA, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Moxifloxacin Hydrochloride.
- What is the active ingredient?
- Moxifloxacin hydrochloride.
- Who is the labeler?
- Asclemed USA, Inc., NDC labeler code 76420. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Moxifloxacin Hydrochloride?
- 19 other product NDCs are listed under this name. See all Moxifloxacin Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Moxifloxacin Hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Moxifloxacin Hydrochloride | Moxifloxacin hydrochloride 400 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4458 | 70518-4458-00 |
| Moxifloxacin Hydrochloride | Moxifloxacin hydrochloride 5 mg/mL | Solution/ dropsOphthalmic | Redpharm Drug | 67296-2232 | 67296-2232-03 |
| Moxifloxacin Hydrochloride | Moxifloxacin hydrochloride 5 mg/mL | Solution/ dropsOphthalmic | Somerset Therapeutics, LLC | 70069-081 | 70069-0081-01 |
| Moxifloxacin Hydrochloride | Moxifloxacin hydrochloride 400 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-7407 | 00904-7407-0400904-7407-06 |
| Moxifloxacin Hydrochloride | Moxifloxacin hydrochloride 400 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-3738 | 70518-3738-00 |
| Moxifloxacin Hydrochloride | Moxifloxacin hydrochloride 5 mg/mL | SolutionOphthalmic | Upsher-Smith Laboratories, LLC | 0832-1410 | 00832-1410-03 |
| Moxifloxacin Hydrochloride | Moxifloxacin hydrochloride 400 mg/250mL | Injection, SolutionIntravenous | Mylan Institutional LLC | 67457-323 | 67457-0323-25 |
| Moxifloxacin Hydrochloride | Moxifloxacin hydrochloride 400 mg/1 | Tablet, Film coatedOral | AvPAK | 50268-576 | 50268-0576-13 |
| Moxifloxacin Hydrochloride | Moxifloxacin hydrochloride 400 mg/1 | Tablet, Film coatedOral | American Health Packaging | 68084-722 | 68084-0722-65 |
| Moxifloxacin Hydrochloride | Moxifloxacin hydrochloride 400 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6609 | 50090-6609-0050090-6609-01 |
Other NDCs under ANDA 212616
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 Hydrochloride | Moxifloxacin hydrochloride 5 mg/mL | SolutionOphthalmic | Upsher-Smith Laboratories, LLC | 0832-1410 |