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United States · US · US:64980-448_4b15047c-4c19-4562-ba03-5c1aff192a2f
Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspension
Orange BookUNIISPLATC D07AB
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerRising Pharma Holdings, Inc.
CountryUS (United States)
ATC codeD07AB
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1164980448011 BOTTLE in 1 CARTON (64980-448-01) / 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": "64980-448_4b15047c-4c19-4562-ba03-5c1aff192a2f",
"productndc": "64980-448",
"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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