maxitrol

Generic: neomycin sulfate, polymyxin b sulfate and dexamethasone

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

Drug Facts

Product Profile

Brand Name maxitrol
Generic Name neomycin sulfate, polymyxin b sulfate and dexamethasone
Labeler harrow eye, llc
Dosage Form SUSPENSION
Routes
OPHTHALMIC
Active Ingredients

dexamethasone 1 mg/mL, neomycin sulfate 3.5 mg/mL, polymyxin b sulfate 10000 [USP'U]/mL

Manufacturer
Harrow Eye, LLC

Identifiers & Regulatory

Product NDC 82667-100
Product ID 82667-100_41ef9a7f-c1aa-de10-e063-6394a90adeec
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA050023
Listing Expiration 2026-12-31
Marketing Start 1964-11-15

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 82667100
Hyphenated Format 82667-100

Supplemental Identifiers

RxCUI
208591 309680
UPC
0382667100058
UNII
7S5I7G3JQL 057Y626693 19371312D4
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 maxitrol (source: ndc)
Generic Name neomycin sulfate, polymyxin b sulfate and dexamethasone (source: ndc)
Application Number NDA050023 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
  • 3.5 mg/mL
  • 10000 [USP'U]/mL
source: ndc
Packaging
  • 5 mL in 1 BOTTLE, PLASTIC (82667-100-05)
source: ndc

Packages (1)

82667-100-05 5 mL in 1 BOTTLE, PLASTIC (82667-100-05)

Ingredients (3)

dexamethasone (1 mg/mL) neomycin sulfate (3.5 mg/mL) polymyxin b sulfate (10000 [USP'U]/mL)

Linked Drug Pages (1)

Maxitrol ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "41ef9a7f-c1aa-de10-e063-6394a90adeec", "openfda": {"nui": ["N0000175576", "N0000175450"], "upc": ["0382667100058"], "unii": ["7S5I7G3JQL", "057Y626693", "19371312D4"], "rxcui": ["208591", "309680"], "spl_set_id": ["ecfb954f-5554-0ad2-e053-2995a90a7516"], "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": "5 mL in 1 BOTTLE, PLASTIC (82667-100-05)", "package_ndc": "82667-100-05", "marketing_start_date": "20231101"}], "brand_name": "Maxitrol", "product_id": "82667-100_41ef9a7f-c1aa-de10-e063-6394a90adeec", "dosage_form": "SUSPENSION", "pharm_class": ["Aminoglycoside Antibacterial [EPC]", "Aminoglycosides [CS]", "Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]", "Polymyxin-class Antibacterial [EPC]", "Polymyxins [CS]"], "product_ndc": "82667-100", "generic_name": "neomycin sulfate, polymyxin b sulfate and dexamethasone", "labeler_name": "Harrow Eye, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Maxitrol", "active_ingredients": [{"name": "DEXAMETHASONE", "strength": "1 mg/mL"}, {"name": "NEOMYCIN SULFATE", "strength": "3.5 mg/mL"}, {"name": "POLYMYXIN B SULFATE", "strength": "10000 [USP'U]/mL"}], "application_number": "NDA050023", "marketing_category": "NDA", "marketing_start_date": "19641115", "listing_expiration_date": "20261231"}