moxifloxacin

Generic: moxifloxacin hydrochloride

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name moxifloxacin
Generic Name moxifloxacin hydrochloride
Labeler fresenius kabi usa, llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

moxifloxacin hydrochloride 400 mg/250mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-850
Product ID 63323-850_4070f637-059f-4e3d-8cf3-e5256a46ff3e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA205572
Listing Expiration 2026-12-31
Marketing Start 2015-03-18

Pharmacologic Class

Classes
fluoroquinolone antibacterial [epc] fluoroquinolones [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63323850
Hyphenated Format 63323-850

Supplemental Identifiers

RxCUI
351156
UNII
C53598599T

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name moxifloxacin (source: ndc)
Generic Name moxifloxacin hydrochloride (source: ndc)
Application Number NDA205572 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 400 mg/250mL
source: ndc
Packaging
  • 12 BAG in 1 CASE (63323-850-04) / 250 mL in 1 BAG (63323-850-74)
source: ndc

Packages (1)

63323-850-04 12 BAG in 1 CASE (63323-850-04) / 250 mL in 1 BAG (63323-850-74)

Ingredients (1)

moxifloxacin hydrochloride (400 mg/250mL)

Linked Drug Pages (1)

Moxifloxacin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "4070f637-059f-4e3d-8cf3-e5256a46ff3e", "openfda": {"unii": ["C53598599T"], "rxcui": ["351156"], "spl_set_id": ["a4e28b09-714b-46e7-b4e6-0163cad78fc5"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "12 BAG in 1 CASE (63323-850-04)  / 250 mL in 1 BAG (63323-850-74)", "package_ndc": "63323-850-04", "marketing_start_date": "20150318"}], "brand_name": "Moxifloxacin", "product_id": "63323-850_4070f637-059f-4e3d-8cf3-e5256a46ff3e", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Fluoroquinolone Antibacterial [EPC]", "Fluoroquinolones [CS]"], "product_ndc": "63323-850", "generic_name": "MOXIFLOXACIN HYDROCHLORIDE", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Moxifloxacin", "active_ingredients": [{"name": "MOXIFLOXACIN HYDROCHLORIDE", "strength": "400 mg/250mL"}], "application_number": "NDA205572", "marketing_category": "NDA", "marketing_start_date": "20150318", "listing_expiration_date": "20261231"}