moxifloxacin hydrochloride

Generic: moxifloxacin hydrochloride

Labeler: major pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name moxifloxacin hydrochloride
Generic Name moxifloxacin hydrochloride
Labeler major pharmaceuticals
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

moxifloxacin hydrochloride 400 mg/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-7407
Product ID 0904-7407_eeab280e-fdca-45ae-b2ae-325799c9c3ff
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202632
Listing Expiration 2026-12-31
Marketing Start 2024-03-08

Pharmacologic Class

Classes
fluoroquinolone antibacterial [epc] fluoroquinolones [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 09047407
Hyphenated Format 0904-7407

Supplemental Identifiers

RxCUI
311787
UNII
C53598599T

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 ANDA202632 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/1
source: ndc
Packaging
  • 30 BLISTER PACK in 1 CARTON (0904-7407-04) / 1 TABLET, FILM COATED in 1 BLISTER PACK
  • 50 BLISTER PACK in 1 CARTON (0904-7407-06) / 1 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (2)

0904-7407-04 30 BLISTER PACK in 1 CARTON (0904-7407-04) / 1 TABLET, FILM COATED in 1 BLISTER PACK 0904-7407-06 50 BLISTER PACK in 1 CARTON (0904-7407-06) / 1 TABLET, FILM COATED in 1 BLISTER PACK

Ingredients (1)

moxifloxacin hydrochloride (400 mg/1)

Linked Drug Pages (1)

MOXIFLOXACIN HYDROCHLORIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "eeab280e-fdca-45ae-b2ae-325799c9c3ff", "openfda": {"unii": ["C53598599T"], "rxcui": ["311787"], "spl_set_id": ["815d71cf-02de-4190-9bd1-3fdc67ef0f06"], "manufacturer_name": ["Major Pharmaceuticals"]}, "finished": true, "packaging": [{"sample": false, "description": "30 BLISTER PACK in 1 CARTON (0904-7407-04)  / 1 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "0904-7407-04", "marketing_start_date": "20240308"}, {"sample": false, "description": "50 BLISTER PACK in 1 CARTON (0904-7407-06)  / 1 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "0904-7407-06", "marketing_start_date": "20240308"}], "brand_name": "MOXIFLOXACIN HYDROCHLORIDE", "product_id": "0904-7407_eeab280e-fdca-45ae-b2ae-325799c9c3ff", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Fluoroquinolone Antibacterial [EPC]", "Fluoroquinolones [CS]"], "product_ndc": "0904-7407", "generic_name": "moxifloxacin hydrochloride", "labeler_name": "Major Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "MOXIFLOXACIN HYDROCHLORIDE", "active_ingredients": [{"name": "MOXIFLOXACIN HYDROCHLORIDE", "strength": "400 mg/1"}], "application_number": "ANDA202632", "marketing_category": "ANDA", "marketing_start_date": "20240308", "listing_expiration_date": "20261231"}