maxitrol

Generic: neomycin sulfate, polymyxin b sulfate and dexamethasone

Labeler: novartis pharmaceuticals corporation
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 novartis pharmaceuticals corporation
Dosage Form OINTMENT
Routes
OPHTHALMIC
Active Ingredients

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

Manufacturer
Novartis Pharmaceuticals Corporation

Identifiers & Regulatory

Product NDC 0078-0771
Product ID 0078-0771_6328676b-98d9-4548-bc41-117e0e21eba6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA050065
Marketing Start 1972-01-17
Marketing End 2027-02-28

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 00780771
Hyphenated Format 0078-0771

Supplemental Identifiers

RxCUI
208601 309679
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 NDA050065 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 1 mg/g
  • 3.5 mg/g
  • 10000 [USP'U]/g
source: ndc
Packaging
  • 3.5 g in 1 TUBE (0078-0771-01)
source: ndc

Packages (1)

0078-0771-01 3.5 g in 1 TUBE (0078-0771-01)

Ingredients (3)

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

Linked Drug Pages (1)

MAXITROL ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "6328676b-98d9-4548-bc41-117e0e21eba6", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["7S5I7G3JQL", "057Y626693", "19371312D4"], "rxcui": ["208601", "309679"], "spl_set_id": ["22c6d2db-85af-4a3b-a014-80d901a86717"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Novartis Pharmaceuticals Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3.5 g in 1 TUBE (0078-0771-01)", "package_ndc": "0078-0771-01", "marketing_end_date": "20270228", "marketing_start_date": "20200825"}], "brand_name": "MAXITROL", "product_id": "0078-0771_6328676b-98d9-4548-bc41-117e0e21eba6", "dosage_form": "OINTMENT", "pharm_class": ["Aminoglycoside Antibacterial [EPC]", "Aminoglycosides [CS]", "Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]", "Polymyxin-class Antibacterial [EPC]", "Polymyxins [CS]"], "product_ndc": "0078-0771", "generic_name": "neomycin sulfate, polymyxin b sulfate and dexamethasone", "labeler_name": "Novartis Pharmaceuticals Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "MAXITROL", "active_ingredients": [{"name": "DEXAMETHASONE", "strength": "1 mg/g"}, {"name": "NEOMYCIN SULFATE", "strength": "3.5 mg/g"}, {"name": "POLYMYXIN B SULFATE", "strength": "10000 [USP'U]/g"}], "application_number": "NDA050065", "marketing_category": "NDA", "marketing_end_date": "20270228", "marketing_start_date": "19720117"}