moxifloxacin hydrochloride

Generic: moxifloxacin hydrochloride

Labeler: asclemed usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name moxifloxacin hydrochloride
Generic Name moxifloxacin hydrochloride
Labeler asclemed usa, inc.
Dosage Form SOLUTION
Routes
OPHTHALMIC
Active Ingredients

moxifloxacin hydrochloride 5 mg/mL

Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-331
Product ID 76420-331_331b69c5-5ad7-a90a-e063-6394a90acfd6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212616
Listing Expiration 2026-12-31
Marketing Start 2021-02-10

Pharmacologic Class

Classes
fluoroquinolone antibacterial [epc] fluoroquinolones [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76420331
Hyphenated Format 76420-331

Supplemental Identifiers

RxCUI
403818
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 ANDA212616 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (76420-331-03) / 3 mL in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

76420-331-03 1 BOTTLE, PLASTIC in 1 CARTON (76420-331-03) / 3 mL in 1 BOTTLE, PLASTIC

Ingredients (1)

moxifloxacin hydrochloride (5 mg/mL)

Linked Drug Pages (1)

Moxifloxacin Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "331b69c5-5ad7-a90a-e063-6394a90acfd6", "openfda": {"unii": ["C53598599T"], "rxcui": ["403818"], "spl_set_id": ["8f92f110-32d6-4d0c-a415-7a9a4cafb9b8"], "manufacturer_name": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (76420-331-03)  / 3 mL in 1 BOTTLE, PLASTIC", "package_ndc": "76420-331-03", "marketing_start_date": "20250419"}], "brand_name": "Moxifloxacin Hydrochloride", "product_id": "76420-331_331b69c5-5ad7-a90a-e063-6394a90acfd6", "dosage_form": "SOLUTION", "pharm_class": ["Fluoroquinolone Antibacterial [EPC]", "Fluoroquinolones [CS]"], "product_ndc": "76420-331", "generic_name": "Moxifloxacin Hydrochloride", "labeler_name": "Asclemed USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Moxifloxacin Hydrochloride", "active_ingredients": [{"name": "MOXIFLOXACIN HYDROCHLORIDE", "strength": "5 mg/mL"}], "application_number": "ANDA212616", "marketing_category": "ANDA", "marketing_start_date": "20210210", "listing_expiration_date": "20261231"}