Prescription drug · ANDA
Moxifloxacin Ophthalmic Solution (Moxifloxacin ophthalmic) NDC 68083-210
Moxifloxacin hydrochloride 5 mg/mL · Solution/ drops · Ophthalmic · Gland Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68083-210-01 | 6808302100168083021001 | 1 BOTTLE, PLASTIC in 1 CARTON (68083-210-01) / 3 mL in 1 BOTTLE, PLASTICMarketed from Mar 30, 2020 |
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 Ophthalmic Solution
- Generic name (nonproprietary)
- moxifloxacin ophthalmic
- Active ingredients
- Moxifloxacin hydrochloride — 5 mg/mL
- Dosage form
- Solution/ drops
- Route
- Ophthalmic
- Labeler
- Gland Pharma LimitedNDC labeler code 68083
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208778
- Marketing start
- Listing expires
- Other FDA classes
- Quinolones (Chemical structure)
- Identifiers
- Product ID 68083-210_1762525e-0af9-445f-ab67-00bfa954dc7dSPL ID 1762525e-0af9-445f-ab67-00bfa954dc7dSPL set ID 95773bca-0791-4bfe-955a-4d2fa4561e01RxCUI 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
N468083021001followed by a unit qualifier and the quantityPackage 68083-0210-01. 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 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 68083-210
- What is NDC 68083-210?
- 68083-210 is the product NDC for Moxifloxacin Ophthalmic Solution (moxifloxacin ophthalmic), Moxifloxacin hydrochloride 5 mg/mL solution/ drops, listed with the FDA by Gland Pharma Limited. 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?
- Gland Pharma Limited, NDC labeler code 68083. 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 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 |
| Moxifloxacin Ophthalmic Solutionmoxifloxacin hydrochloride | Moxifloxacin hydrochloride 5 mg/mL | Solution/ dropsOphthalmic | Sandoz Inc | 0781-7135 | 00781-7135-93 |
Other NDCs under ANDA 208778
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 | Moxifloxacin hydrochloride 5 mg/mL | Solution/ dropsOphthalmic | A-S Medication Solutions | 50090-6248 |
| Moxifloxacin Ophthalmic Solutionmoxifloxacin ophthalmic | Moxifloxacin hydrochloride 5 mg/mL | Solution/ dropsOphthalmic | Fosun Pharma USA Inc. | 72266-158 |