Prescription drug · NDA
Moxifloxacin (Moxifloxacin hydrochloride) NDC 66298-8507
Moxifloxacin hydrochloride 400 mg/250mL · Injection, Solution · Intravenous · Hp Halden Pharma AS
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 66298-8507-4 | 6629885070466298850704 | 250 mL in 1 BAG (66298-8507-4)Marketed from Aug 2, 2017 |
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 hydrochloride
- Active ingredients
- Moxifloxacin hydrochloride — 400 mg/250mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Hp Halden Pharma ASNDC labeler code 66298
- 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 66298-8507_1d783072-b073-e384-e063-6394a90a7460SPL ID 1d783072-b073-e384-e063-6394a90a7460SPL set ID 6067b2ee-2171-49bb-aa07-1d401ebf4f2eRxCUI 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
N466298850704followed by a unit qualifier and the quantityPackage 66298-8507-04. 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 ) 1.1 Community Acquired Pneumonia Moxifloxacin Injection is indicated in adults (18 years of age or older) for the treatment of Community Acquired Pneumonia caused by susceptible isolates of Streptococcus pneumoniae (including multi-drug resistant isolates*), …
Excerpt only. Read the full label for complete information.
About NDC 66298-8507
- What is NDC 66298-8507?
- 66298-8507 is the product NDC for Moxifloxacin (moxifloxacin hydrochloride), Moxifloxacin hydrochloride 400 mg/250mL injection, solution, listed with the FDA by Hp Halden Pharma AS. 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?
- Hp Halden Pharma AS, NDC labeler code 66298. 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 | Fresenius Kabi USA, LLC | 63323-850 |