Prescription drug · NDA
Moxifloxacin (Moxifloxacin hydrochloride) NDC 63323-850
Moxifloxacin hydrochloride 400 mg/250mL · Injection, Solution · Intravenous · Fresenius Kabi USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63323-850-04 | 6332308500463323085004 | 12 BAG in 1 CASE (63323-850-04) / 250 mL in 1 BAG (63323-850-74)Marketed from Mar 18, 2015 |
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
- Generic name (nonproprietary)
- moxifloxacin hydrochloride
- Active ingredients
- Moxifloxacin hydrochloride — 400 mg/250mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Fresenius Kabi USA, LLCNDC labeler code 63323
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 205572
- Marketing start
- Listing expires
- Other FDA classes
- Fluoroquinolones (Chemical structure)
- Identifiers
- Product ID 63323-850_4070f637-059f-4e3d-8cf3-e5256a46ff3eSPL ID 4070f637-059f-4e3d-8cf3-e5256a46ff3eSPL set ID a4e28b09-714b-46e7-b4e6-0163cad78fc5RxCUI 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
N463323085004followed by a unit qualifier and the quantityPackage 63323-0850-04. 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 Injection is a fluoroquinolone antibacterial drug indicated for treating infections in adults ≥ 18 years of age caused by designated, susceptible bacteria. ( 1 , 12.4 ) Community Acquired Pneumonia ( 1.1 ) Skin and Skin Structure Infections: Uncomplicated ( 1.2 ) and Complicated ( 1.3 ) Complicated Intra-Abdominal Infections ( 1.4 ) Acute Bacterial Sinusitis ( 1.5 ) Acute Bacterial Exacerbation of Chronic Bronchitis ( 1.6 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of Moxifloxacin Injection and other antibacterial drugs, Moxifloxacin Injection should be used only to treat or prevent infections that are proven or strongly suspected to be …
Excerpt only. Read the full label for complete information.
About NDC 63323-850
- What is NDC 63323-850?
- 63323-850 is the product NDC for Moxifloxacin (moxifloxacin hydrochloride), Moxifloxacin hydrochloride 400 mg/250mL injection, solution, listed with the FDA by Fresenius Kabi USA, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Moxifloxacin (Moxifloxacin hydrochloride).
- What is the active ingredient?
- Moxifloxacin hydrochloride.
- Who is the labeler?
- Fresenius Kabi USA, LLC, NDC labeler code 63323. 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 monohydrate 5 mg/mL | Solution/ dropsOphthalmic | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0239 | 80425-0239-01 |
| 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 |
Other NDCs under NDA 205572
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 |
|---|---|---|---|---|
| Moxifloxacinmoxifloxacin hydrochloride | Moxifloxacin hydrochloride 400 mg/250mL | Injection, SolutionIntravenous | Hp Halden Pharma AS | 66298-8507 |