🇺🇸
United States · US · US:63481-529_ec1e8a16-a5be-4ff7-a8fe-e0cbfd25aea6
Cortisporin TC
Orange BookUNIISPLATC A07AA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerEndo USA, Inc.
CountryUS (United States)
ATC codeA07AA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11634815291010 mL in 1 BOTTLE, DROPPER (63481-529-10)
Annotations
UNII (FDA Substance ID)
WP15DXU577
COLISTIN SULFATE
RxCUI 2710
Orange Book
N050356
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "WP15DXU577",
"rxcui": "2710",
"inchikey": null,
"display_name": "COLISTIN SULFATE",
"substance_type": "mixture",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "AURICULAR (OTIC)",
"spl_meta": {
"9c6fc1c7-3350-42ae-b999-aca48e704bb1": {
"match": "brand_token",
"title": "CORTISPORIN TC (COLISTIN SULFATE, NEOMYCIN SULFATE, THONZONIUM BROMIDE AND HYDROCORTISONE ACETATE) SUSPENSION [ENDO USA, INC.]",
"spl_version": "6",
"published_date": "2025-12-08"
}
},
"productid": "63481-529_ec1e8a16-a5be-4ff7-a8fe-e0cbfd25aea6",
"productndc": "63481-529",
"dosage_form": "SUSPENSION",
"orange_book": {
"appl_no": "050356",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 3MG BASE/ML;10MG/ML;EQ 3.3MG BASE/ML;0.5MG/ML",
"product_no": "001",
"approval_date": "Approved Prior to Jan 1, 1982"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "COLISTIN SULFATE; HYDROCORTISONE ACETATE; NEOMYCIN SULFATE; THONZONIUM BROMIDE",
"proprietary_name": "Cortisporin TC",
"active_ingred_unit": "mg/mL; mg/mL; mg/mL; mg/mL",
"application_number": "NDA050356",
"marketing_category": "NDA",
"nonproprietary_name": "colistin sulfate, neomycin sulfate, thonzonium bromide and hydrocortisone acetate",
"start_marketing_date": "20190603",
"active_numerator_strength": "3; 10; 3.3; .5"
}Related drugs
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