moxifloxacin

Generic: moxifloxacin hydrochloride

Labeler: hp halden pharma as
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name moxifloxacin
Generic Name moxifloxacin hydrochloride
Labeler hp halden pharma as
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

moxifloxacin hydrochloride 400 mg/250mL

Manufacturer
Hp Halden Pharma AS

Identifiers & Regulatory

Product NDC 66298-8507
Product ID 66298-8507_1d783072-b073-e384-e063-6394a90a7460
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA205572
Listing Expiration 2026-12-31
Marketing Start 2017-08-02

Pharmacologic Class

Classes
fluoroquinolone antibacterial [epc] fluoroquinolones [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 662988507
Hyphenated Format 66298-8507

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
  • 250 mL in 1 BAG (66298-8507-4)
source: ndc

Packages (1)

66298-8507-4 250 mL in 1 BAG (66298-8507-4)

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": "1d783072-b073-e384-e063-6394a90a7460", "openfda": {"unii": ["C53598599T"], "rxcui": ["351156"], "spl_set_id": ["6067b2ee-2171-49bb-aa07-1d401ebf4f2e"], "manufacturer_name": ["Hp Halden Pharma AS"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "250 mL in 1 BAG (66298-8507-4)", "package_ndc": "66298-8507-4", "marketing_start_date": "20170802"}], "brand_name": "Moxifloxacin", "product_id": "66298-8507_1d783072-b073-e384-e063-6394a90a7460", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Fluoroquinolone Antibacterial [EPC]", "Fluoroquinolones [CS]"], "product_ndc": "66298-8507", "generic_name": "MOXIFLOXACIN HYDROCHLORIDE", "labeler_name": "Hp Halden Pharma AS", "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": "20170802", "listing_expiration_date": "20261231"}