moxifloxacin hydrochloride

Generic: moxifloxacin hydrochloride

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name moxifloxacin hydrochloride
Generic Name moxifloxacin hydrochloride
Labeler aurobindo pharma limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

moxifloxacin hydrochloride 400 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-603
Product ID 65862-603_412cb5bf-66ad-4815-bf15-8d225c09260b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202632
Listing Expiration 2026-12-31
Marketing Start 2014-03-04

Pharmacologic Class

Classes
fluoroquinolone antibacterial [epc] fluoroquinolones [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65862603
Hyphenated Format 65862-603

Supplemental Identifiers

RxCUI
311787
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 ANDA202632 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (65862-603-30)
  • 50 BLISTER PACK in 1 BOX, UNIT-DOSE (65862-603-55) / 1 TABLET, FILM COATED in 1 BLISTER PACK (65862-603-10)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (65862-603-99)
source: ndc

Packages (3)

65862-603-30 30 TABLET, FILM COATED in 1 BOTTLE (65862-603-30) 65862-603-55 50 BLISTER PACK in 1 BOX, UNIT-DOSE (65862-603-55) / 1 TABLET, FILM COATED in 1 BLISTER PACK (65862-603-10) 65862-603-99 1000 TABLET, FILM COATED in 1 BOTTLE (65862-603-99)

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": "412cb5bf-66ad-4815-bf15-8d225c09260b", "openfda": {"unii": ["C53598599T"], "rxcui": ["311787"], "spl_set_id": ["d6789c17-4a2f-4519-9060-e3b0dba422f0"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (65862-603-30)", "package_ndc": "65862-603-30", "marketing_start_date": "20140304"}, {"sample": false, "description": "50 BLISTER PACK in 1 BOX, UNIT-DOSE (65862-603-55)  / 1 TABLET, FILM COATED in 1 BLISTER PACK (65862-603-10)", "package_ndc": "65862-603-55", "marketing_start_date": "20140304"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (65862-603-99)", "package_ndc": "65862-603-99", "marketing_start_date": "20140304"}], "brand_name": "MOXIFLOXACIN HYDROCHLORIDE", "product_id": "65862-603_412cb5bf-66ad-4815-bf15-8d225c09260b", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Fluoroquinolone Antibacterial [EPC]", "Fluoroquinolones [CS]"], "product_ndc": "65862-603", "generic_name": "moxifloxacin hydrochloride", "labeler_name": "Aurobindo Pharma Limited", "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": "20140304", "listing_expiration_date": "20261231"}