Prescription drug · ANDA
Moxifloxacin Hydrochloride NDC 70069-081
Moxifloxacin hydrochloride 5 mg/mL · Solution/ drops · Ophthalmic · Somerset Therapeutics, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70069-081-01 | 7006900810170069008101 | 1 BOTTLE in 1 CARTON (70069-081-01) / 3 mL in 1 BOTTLEMarketed from Nov 25, 2024 |
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/ drops
- Route
- Ophthalmic
- Labeler
- Somerset Therapeutics, LLCNDC labeler code 70069
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209698
- Marketing start
- Listing expires
- Other FDA classes
- Fluoroquinolones (Chemical structure)
- Identifiers
- Product ID 70069-081_1a4f432a-c2b2-46bc-88fc-7379c2bbd0a2SPL ID 1a4f432a-c2b2-46bc-88fc-7379c2bbd0a2SPL set ID f7c68d49-8c61-4bde-a880-4d78568e5aa0RxCUI 403818UNII C53598599TUPC 0370069081013
- 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
N470069008101followed by a unit qualifier and the quantityPackage 70069-0081-01. 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 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 70069-081
- What is NDC 70069-081?
- 70069-081 is the product NDC for Moxifloxacin Hydrochloride, Moxifloxacin hydrochloride 5 mg/mL solution/ drops, listed with the FDA by Somerset Therapeutics, LLC. 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?
- Somerset Therapeutics, LLC, NDC labeler code 70069. 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 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 5 mg/mL | SolutionOphthalmic | Asclemed USA, Inc. | 76420-331 | 76420-0331-03 |
| 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 209698
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 | Solution/ dropsOphthalmic | Redpharm Drug | 67296-2232 |