moxifloxacin hydrochloride

Generic: moxifloxacin hydrochloride

Labeler: mylan institutional llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name moxifloxacin hydrochloride
Generic Name moxifloxacin hydrochloride
Labeler mylan institutional llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

moxifloxacin hydrochloride 400 mg/250mL

Manufacturer
Mylan Institutional LLC

Identifiers & Regulatory

Product NDC 67457-323
Product ID 67457-323_c193663f-0749-4372-aab1-c43eb1b596e4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205833
Listing Expiration 2027-12-31
Marketing Start 2017-10-03

Pharmacologic Class

Classes
fluoroquinolone antibacterial [epc] fluoroquinolones [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 67457323
Hyphenated Format 67457-323

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 hydrochloride (source: ndc)
Generic Name moxifloxacin hydrochloride (source: ndc)
Application Number ANDA205833 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 400 mg/250mL
source: ndc
Packaging
  • 1 BAG in 1 CARTON (67457-323-25) / 250 mL in 1 BAG
source: ndc

Packages (1)

67457-323-25 1 BAG in 1 CARTON (67457-323-25) / 250 mL in 1 BAG

Ingredients (1)

moxifloxacin hydrochloride (400 mg/250mL)

Linked Drug Pages (1)

MOXIFLOXACIN HYDROCHLORIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "c193663f-0749-4372-aab1-c43eb1b596e4", "openfda": {"unii": ["C53598599T"], "rxcui": ["351156"], "spl_set_id": ["c6fa4129-2f92-4179-ac5d-bb7b4a538789"], "manufacturer_name": ["Mylan Institutional LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BAG in 1 CARTON (67457-323-25)  / 250 mL in 1 BAG", "package_ndc": "67457-323-25", "marketing_start_date": "20171003"}], "brand_name": "MOXIFLOXACIN HYDROCHLORIDE", "product_id": "67457-323_c193663f-0749-4372-aab1-c43eb1b596e4", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Fluoroquinolone Antibacterial [EPC]", "Fluoroquinolones [CS]"], "product_ndc": "67457-323", "generic_name": "MOXIFLOXACIN HYDROCHLORIDE", "labeler_name": "Mylan Institutional LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "MOXIFLOXACIN HYDROCHLORIDE", "active_ingredients": [{"name": "MOXIFLOXACIN HYDROCHLORIDE", "strength": "400 mg/250mL"}], "application_number": "ANDA205833", "marketing_category": "ANDA", "marketing_start_date": "20171003", "listing_expiration_date": "20271231"}