Prescription drug · NDA AUTHORIZED GENERIC
Moxifloxacin Ophthalmic Solution (Moxifloxacin hydrochloride) NDC 0781-7135
Moxifloxacin hydrochloride 5 mg/mL · Solution/ drops · Ophthalmic · Sandoz Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0781-7135-93 | 0078171359300781713593 | 1 BOTTLE, PLASTIC in 1 CARTON (0781-7135-93) / 3 mL in 1 BOTTLE, PLASTICMarketed from Jun 30, 2017 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 hydrochloride
- Active ingredients
- Moxifloxacin hydrochloride — 5 mg/mL
- Dosage form
- Solution/ drops
- Route
- Ophthalmic
- Labeler
- Sandoz IncNDC labeler code 0781
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 021598
- Marketing start
- Listing expires
- Other FDA classes
- Quinolones (Chemical structure)
- Identifiers
- Product ID 0781-7135_fe09f635-c4f0-4698-8468-d226257b6d58SPL ID fe09f635-c4f0-4698-8468-d226257b6d58SPL set ID fc88791b-24da-48a4-85f5-93a8af3d0b51RxCUI 403818UNII C53598599T
- Pharmacologic class
- Quinolone Antimicrobial
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
N400781713593followed by a unit qualifier and the quantityPackage 00781-7135-93. 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.
About NDC 0781-7135
- What is NDC 0781-7135?
- 0781-7135 is the product NDC for Moxifloxacin Ophthalmic Solution (moxifloxacin hydrochloride), Moxifloxacin hydrochloride 5 mg/mL solution/ drops, listed with the FDA by Sandoz Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Moxifloxacin Ophthalmic Solution (Moxifloxacin hydrochloride).
- What is the active ingredient?
- Moxifloxacin hydrochloride.
- Who is the labeler?
- Sandoz Inc, NDC labeler code 0781. 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 solutionmoxifloxacin ophthalmic | Moxifloxacin hydrochloride 5 mg/mL | Solution/ dropsOphthalmic | A-S Medication Solutions | 50090-4781 | 50090-4781-00 |
| Moxifloxacin ophthalmic solution | Moxifloxacin hydrochloride 5 mg/mL | Solution/ dropsOphthalmic | Alembic Pharmaceuticals Inc. | 62332-505 | 62332-0505-03 |
Other NDCs under NDA 021598
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 |
|---|---|---|---|---|
| Vigamoxmoxifloxacin hydrochloride | Moxifloxacin hydrochloride 5 mg/mL | Solution/ dropsOphthalmic | Harrow Eye, LLC | 82667-700 |