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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

  • ndc11
    5009063360
    1 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"
}

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