🇺🇸
United States · US · US:50090-6336_bf72b106-e8dc-4f1b-bc67-aa6c6f89ed9a
Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspension
Orange BookUNIISPLATC D07AB
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerA-S Medication Solutions
CountryUS (United States)
ATC codeD07AB
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1150090633601 BOTTLE in 1 CARTON (50090-6336-0) / 10 mL in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
WI4X0X7BPJ
HYDROCORTISONE
RxCUI 5492
Orange Book
N060613
AT
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "WI4X0X7BPJ",
"rxcui": "5492",
"inchikey": "JYGXADMDTFJGBT-VWUMJDOOSA-N",
"display_name": "HYDROCORTISONE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "AURICULAR (OTIC)",
"spl_meta": {
"a2f47d77-efd3-4c84-a364-08fb6d9978eb": {
"match": "brand_token",
"title": "NEOMYCIN AND POLYMYXIN B SULFATES SOLUTION [XGEN PHARMACEUTICALS DJB, INC.]",
"spl_version": "18",
"published_date": "2026-05-21"
}
},
"productid": "50090-6336_bf72b106-e8dc-4f1b-bc67-aa6c6f89ed9a",
"productndc": "50090-6336",
"dosage_form": "SUSPENSION",
"orange_book": {
"appl_no": "060613",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AT",
"strength": "1%;EQ 3.5MG BASE/ML;10,000 UNITS/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": "HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE",
"proprietary_name": "Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspension",
"active_ingred_unit": "mg/mL; mg/mL; [USP'U]/mL",
"application_number": "NDA060613",
"marketing_category": "NDA AUTHORIZED GENERIC",
"nonproprietary_name": "neomycin and polymyxin B sulfates and hydrocortisone otic",
"start_marketing_date": "20190315",
"active_numerator_strength": "10; 3.5; 10000"
}Related drugs
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