Prescription drug · ANDA
Moxifloxacin Hydrochloride NDC 67457-323
Moxifloxacin hydrochloride 400 mg/250mL · Injection, Solution · Intravenous · Mylan Institutional LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67457-323-25 | 6745703232567457032325 | 1 BAG in 1 CARTON (67457-323-25) / 250 mL in 1 BAGMarketed from Oct 3, 2017 |
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 — 400 mg/250mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Mylan Institutional LLCNDC labeler code 67457
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205833
- Marketing start
- Listing expires
- Other FDA classes
- Fluoroquinolones (Chemical structure)
- Identifiers
- Product ID 67457-323_4719ed2a-9c0b-466a-90ee-a5f9f305cd02SPL ID 4719ed2a-9c0b-466a-90ee-a5f9f305cd02SPL set ID c6fa4129-2f92-4179-ac5d-bb7b4a538789RxCUI 351156UNII 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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N467457032325followed by a unit qualifier and the quantityPackage 67457-0323-25. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
Moxifloxacin is a fluoroquinolone antibacterial indicated for treating infections in adults 18 years of age and older caused by designated susceptible bacteria, in the conditions listed below: • Community Acquired Pneumonia ( 1.1 ) • Skin and Skin Structure Infections: Uncomplicated ( 1.2 ) and Complicated ( 1.3 ) • Complicated Intra-Abdominal Infections ( 1.4 ) • Plague ( 1.5 ) • Acute Bacterial Sinusitis ( 1.6 ) • Acute Bacterial Exacerbation of Chronic Bronchitis ( 1.7 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of moxifloxacin and other antibacterial drugs. Moxifloxacin should be used only to treat or prevent infections that are proven or strongl…
Excerpt only. Read the full label for complete information.
About NDC 67457-323
- What is NDC 67457-323?
- 67457-323 is the product NDC for Moxifloxacin Hydrochloride, Moxifloxacin hydrochloride 400 mg/250mL injection, solution, listed with the FDA by Mylan Institutional 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?
- Mylan Institutional LLC, NDC labeler code 67457. 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 5 mg/mL | Solution/ dropsOphthalmic | Somerset Therapeutics, LLC | 70069-081 | 70069-0081-01 |
| 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/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 |