Prescription drug · ANDA
Moxifloxacin NDC 80425-0239
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 |
|---|---|---|---|
| 80425-0239-1 | 8042502390180425023901 | 1 BOTTLE, DROPPER in 1 CARTON (80425-0239-1) / 3 mL in 1 BOTTLE, DROPPERMarketed from Jan 11, 2023 |
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
- Labeler
- Advanced Rx Pharmacy of Tennessee, LLCNDC labeler code 80425
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090080
- Marketing start
- Listing expires
- Other FDA classes
- Fluoroquinolones (Chemical structure)
- Identifiers
- Product ID 80425-0239_2a9aa671-d0a2-2254-e063-6294a90a9f79SPL ID 2a9aa671-d0a2-2254-e063-6294a90a9f79SPL set ID f19fa89e-9f5d-4eed-e053-2995a90ac3ceRxCUI 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
N480425023901followed by a unit qualifier and the quantityPackage 80425-0239-01. 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)
1. Indications and Usage 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.
Excerpt only. Read the full label for complete information.
About NDC 80425-0239
- What is NDC 80425-0239?
- 80425-0239 is the product NDC for Moxifloxacin, Moxifloxacin hydrochloride monohydrate 5 mg/mL solution/ drops, listed with the FDA by Advanced Rx Pharmacy of Tennessee, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Moxifloxacin.
- What is the active ingredient?
- Moxifloxacin hydrochloride monohydrate.
- Who is the labeler?
- Advanced Rx Pharmacy of Tennessee, LLC, NDC labeler code 80425. 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?
- 23 other product NDCs are listed under this name. See all Moxifloxacin NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Moxifloxacin 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 | Moxifloxacin hydrochloride 400 mg/1 | Tablet, Film coatedOral | Macleods Pharmaceuticals Limited | 33342-322 | 33342-0322-0733342-0322-12 |
| Moxifloxacinmoxifloxacin hydrochloride | Moxifloxacin hydrochloride 400 mg/1 | Tablet, Film coatedOral | Solaris Pharma Corporation | 73473-903 | 73473-0903-30 |
| Moxifloxacin | Moxifloxacin hydrochloride monohydrate 5 mg/mL | Solution/ dropsOphthalmic | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0379 | 80425-0379-01 |
| Moxifloxacin | Moxifloxacin hydrochloride 400 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-845 | 31722-0845-0531722-0845-30 |
| Moxifloxacin | Moxifloxacin hydrochloride 5 mg/mL | Solution/ dropsOphthalmic | Direct Rx | 72189-334 | 72189-0334-05 |
| Moxifloxacin | Moxifloxacin hydrochloride monohydrate 5 mg/mL | Solution/ dropsOphthalmic | Direct Rx | 72189-321 | 72189-0321-05 |
| Moxifloxacin | Moxifloxacin hydrochloride 5 mg/mL | SolutionOphthalmic | Lupin Pharmaceuticals, Inc. | 68180-421 | 68180-0421-01 |
| Moxifloxacin | Moxifloxacin hydrochloride 5 mg/mL | Solution/ dropsOphthalmic | NorthStar Rx LLC | 16714-643 | 16714-0643-01 |
| Moxifloxacin | Moxifloxacin hydrochloride 5 mg/mL | Solution/ dropsOphthalmic | A-S Medication Solutions | 50090-8029 | 50090-8029-00 |
| Moxifloxacin | Moxifloxacin hydrochloride 5 mg/mL | Solution/ dropsOphthalmic | Aurobindo Pharma Limited | 65862-840 | 65862-0840-03 |
Other NDCs under ANDA 090080
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 monohydrate 5 mg/mL | Solution/ dropsOphthalmic | Golden State Medical Supply, Inc. | 51407-321 |
| Moxifloxacin | Moxifloxacin hydrochloride monohydrate 5 mg/mL | Solution/ dropsOphthalmic | Apotex Corp. | 60505-0582 |
| Moxifloxacin | Moxifloxacin hydrochloride monohydrate 5 mg/mL | Solution/ dropsOphthalmic | Bryant Ranch Prepack | 72162-2107 |