Prescription drug · ANDA
Moxifloxacin ophthalmic solution (Moxifloxacin ophthalmic) NDC 50090-4781
Moxifloxacin hydrochloride 5 mg/mL · Solution/ drops · Ophthalmic · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-4781-0 | 5009047810050090478100 | 1 BOTTLE in 1 CARTON (50090-4781-0) / 3 mL in 1 BOTTLEMarketed from Dec 5, 2019 |
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 ophthalmic solution
- Generic name (nonproprietary)
- moxifloxacin ophthalmic
- Active ingredients
- Moxifloxacin hydrochloride — 5 mg/mL
- Dosage form
- Solution/ drops
- Route
- Ophthalmic
- Labeler
- A-S Medication SolutionsNDC labeler code 50090
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209469
- Marketing start
- Listing expires
- Other FDA classes
- Fluoroquinolones (Chemical structure)
- Identifiers
- Product ID 50090-4781_7bb7b81f-241e-471c-92bd-daf69035980aSPL ID 7bb7b81f-241e-471c-92bd-daf69035980aSPL set ID e33b3315-54f6-47ce-8a4f-3b79be408540RxCUI 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
N450090478100followed by a unit qualifier and the quantityPackage 50090-4781-00. 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 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.
About NDC 50090-4781
- What is NDC 50090-4781?
- 50090-4781 is the product NDC for Moxifloxacin ophthalmic solution (moxifloxacin ophthalmic), Moxifloxacin hydrochloride 5 mg/mL solution/ drops, listed with the FDA by A-S Medication Solutions. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Moxifloxacin ophthalmic solution (Moxifloxacin ophthalmic).
- What is the active ingredient?
- Moxifloxacin hydrochloride.
- Who is the labeler?
- A-S Medication Solutions, NDC labeler code 50090. 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 ophthalmic solution?
- 7 other product NDCs are listed under this name. See all Moxifloxacin ophthalmic solution NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Moxifloxacin ophthalmic solution 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 ophthalmic solutionmoxifloxacin | Moxifloxacin hydrochloride 5 mg/mL | Solution/ dropsOphthalmic | Redpharm Drug | 67296-2222 | 67296-2222-03 |
| Moxifloxacin ophthalmic solutionmoxifloxacin | Moxifloxacin hydrochloride 5 mg/mL | Solution/ dropsOphthalmic | Lifestar Pharma LLC | 70756-638 | 70756-0638-25 |
| Moxifloxacin Ophthalmic Solutionmoxifloxacin ophthalmic | Moxifloxacin hydrochloride 5 mg/mL | Solution/ dropsOphthalmic | Fosun Pharma USA Inc. | 72266-158 | 72266-0158-01 |
| Moxifloxacin Ophthalmic Solutionmoxifloxacin ophthalmic | Moxifloxacin hydrochloride 5 mg/mL | Solution/ dropsOphthalmic | Gland Pharma Limited | 68083-210 | 68083-0210-01 |
| Moxifloxacin ophthalmic solution | Moxifloxacin hydrochloride 5 mg/mL | Solution/ dropsOphthalmic | Alembic Pharmaceuticals Limited | 46708-505 | 46708-0505-03 |
| Moxifloxacin ophthalmic solution | Moxifloxacin hydrochloride 5 mg/mL | Solution/ dropsOphthalmic | Alembic Pharmaceuticals Inc. | 62332-505 | 62332-0505-03 |
| Moxifloxacin Ophthalmic Solutionmoxifloxacin hydrochloride | Moxifloxacin hydrochloride 5 mg/mL | Solution/ dropsOphthalmic | Sandoz Inc | 0781-7135 | 00781-7135-93 |
Other NDCs under ANDA 209469
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 ophthalmic solution | Moxifloxacin hydrochloride 5 mg/mL | Solution/ dropsOphthalmic | Alembic Pharmaceuticals Limited | 46708-505 |
| Moxifloxacin ophthalmic solution | Moxifloxacin hydrochloride 5 mg/mL | Solution/ dropsOphthalmic | Alembic Pharmaceuticals Inc. | 62332-505 |