maxidex

Generic: dexamethasone

Labeler: harrow eye, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name maxidex
Generic Name dexamethasone
Labeler harrow eye, llc
Dosage Form FOR SUSPENSION
Routes
OPHTHALMIC
Active Ingredients

dexamethasone 1 mg/mL

Manufacturer
Harrow Eye, LLC

Identifiers & Regulatory

Product NDC 82667-600
Product ID 82667-600_34661206-e37a-6ce7-e063-6394a90aaf85
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA013422
Listing Expiration 2026-12-31
Marketing Start 2025-04-07

Pharmacologic Class

Established (EPC)
corticosteroid [epc]
Mechanism of Action
corticosteroid hormone receptor agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 82667600
Hyphenated Format 82667-600

Supplemental Identifiers

RxCUI
205669 309692
UPC
0382667600053
UNII
7S5I7G3JQL
NUI
N0000175576 N0000175450

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 maxidex (source: ndc)
Generic Name dexamethasone (source: ndc)
Application Number NDA013422 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (82667-600-05) / 5 mL in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

82667-600-05 1 BOTTLE, PLASTIC in 1 CARTON (82667-600-05) / 5 mL in 1 BOTTLE, PLASTIC

Ingredients (1)

dexamethasone (1 mg/mL)

Linked Drug Pages (1)

MAXIDEX ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "34661206-e37a-6ce7-e063-6394a90aaf85", "openfda": {"nui": ["N0000175576", "N0000175450"], "upc": ["0382667600053"], "unii": ["7S5I7G3JQL"], "rxcui": ["205669", "309692"], "spl_set_id": ["35e47fcd-e020-43e5-8322-41f8060d220d"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Harrow Eye, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (82667-600-05)  / 5 mL in 1 BOTTLE, PLASTIC", "package_ndc": "82667-600-05", "marketing_start_date": "20250407"}], "brand_name": "MAXIDEX", "product_id": "82667-600_34661206-e37a-6ce7-e063-6394a90aaf85", "dosage_form": "FOR SUSPENSION", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "82667-600", "generic_name": "dexamethasone", "labeler_name": "Harrow Eye, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "MAXIDEX", "active_ingredients": [{"name": "DEXAMETHASONE", "strength": "1 mg/mL"}], "application_number": "NDA013422", "marketing_category": "NDA", "marketing_start_date": "20250407", "listing_expiration_date": "20261231"}