🇺🇸
United States · US · US:61314-646_2a1e7a16-dc94-4cf1-b01f-89e1d7355170
Neomycin and Polymyxin B Sulfates and Hydrocortisone
Orange BookUNIISPLATC D07AB
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSandoz Inc
CountryUS (United States)
ATC codeD07AB
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1161314646101 BOTTLE in 1 CARTON (61314-646-10) / 10 mL in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
WI4X0X7BPJ
HYDROCORTISONE
RxCUI 5492
Orange Book
A062423
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": "61314-646_2a1e7a16-dc94-4cf1-b01f-89e1d7355170",
"productndc": "61314-646",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "062423",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AT",
"strength": "1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML",
"product_no": "001",
"approval_date": "Aug 25, 1983"
}
],
"appl_type": "A"
},
"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",
"active_ingred_unit": "mg/mL; mg/mL; [iU]/mL",
"application_number": "ANDA062423",
"marketing_category": "ANDA",
"nonproprietary_name": "neomycin sulfate, polymyxin b sulfate and hydrocortisone",
"start_marketing_date": "20030318",
"active_numerator_strength": "10; 3.5; 10000"
}Related drugs
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