cortisporin tc

Generic: colistin sulfate, neomycin sulfate, thonzonium bromide and hydrocortisone acetate

Labeler: endo usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name cortisporin tc
Generic Name colistin sulfate, neomycin sulfate, thonzonium bromide and hydrocortisone acetate
Labeler endo usa, inc.
Dosage Form SUSPENSION
Routes
AURICULAR (OTIC)
Active Ingredients

colistin sulfate 3 mg/mL, hydrocortisone acetate 10 mg/mL, neomycin sulfate 3.3 mg/mL, thonzonium bromide .5 mg/mL

Manufacturer
Endo USA, Inc.

Identifiers & Regulatory

Product NDC 63481-529
Product ID 63481-529_ec1e8a16-a5be-4ff7-a8fe-e0cbfd25aea6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA050356
Listing Expiration 2026-12-31
Marketing Start 2019-06-03

Pharmacologic Class

Classes
aminoglycoside antibacterial [epc] aminoglycosides [cs] corticosteroid hormone receptor agonists [moa] corticosteroid [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63481529
Hyphenated Format 63481-529

Supplemental Identifiers

RxCUI
854992 854997
UNII
WP15DXU577 3X7931PO74 057Y626693 JI2B19CR0R

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 cortisporin tc (source: ndc)
Generic Name colistin sulfate, neomycin sulfate, thonzonium bromide and hydrocortisone acetate (source: ndc)
Application Number NDA050356 (source: ndc)
Routes
AURICULAR (OTIC)
source: ndc

Resolved Composition

Strengths
  • 3 mg/mL
  • 10 mg/mL
  • 3.3 mg/mL
  • .5 mg/mL
source: ndc
Packaging
  • 10 mL in 1 BOTTLE, DROPPER (63481-529-10)
source: ndc

Packages (1)

63481-529-10 10 mL in 1 BOTTLE, DROPPER (63481-529-10)

Ingredients (4)

colistin sulfate (3 mg/mL) hydrocortisone acetate (10 mg/mL) neomycin sulfate (3.3 mg/mL) thonzonium bromide (.5 mg/mL)

Linked Drug Pages (1)

Cortisporin TC ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["AURICULAR (OTIC)"], "spl_id": "ec1e8a16-a5be-4ff7-a8fe-e0cbfd25aea6", "openfda": {"unii": ["WP15DXU577", "3X7931PO74", "057Y626693", "JI2B19CR0R"], "rxcui": ["854992", "854997"], "spl_set_id": ["9c6fc1c7-3350-42ae-b999-aca48e704bb1"], "manufacturer_name": ["Endo USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 mL in 1 BOTTLE, DROPPER (63481-529-10)", "package_ndc": "63481-529-10", "marketing_start_date": "20190603"}], "brand_name": "Cortisporin TC", "product_id": "63481-529_ec1e8a16-a5be-4ff7-a8fe-e0cbfd25aea6", "dosage_form": "SUSPENSION", "pharm_class": ["Aminoglycoside Antibacterial [EPC]", "Aminoglycosides [CS]", "Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "63481-529", "generic_name": "colistin sulfate, neomycin sulfate, thonzonium bromide and hydrocortisone acetate", "labeler_name": "Endo USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cortisporin TC", "active_ingredients": [{"name": "COLISTIN SULFATE", "strength": "3 mg/mL"}, {"name": "HYDROCORTISONE ACETATE", "strength": "10 mg/mL"}, {"name": "NEOMYCIN SULFATE", "strength": "3.3 mg/mL"}, {"name": "THONZONIUM BROMIDE", "strength": ".5 mg/mL"}], "application_number": "NDA050356", "marketing_category": "NDA", "marketing_start_date": "20190603", "listing_expiration_date": "20261231"}