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United States · US · US:68071-4174_1a3b96b0-10ac-9bb1-e063-6294a90ab279

Neomycin and Polymyxin B Sulfates and Hydrocortisone

Orange BookUNIISPLATC D07AB

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerNuCare Pharmaceuticals,Inc.
CountryUS (United States)
ATC codeD07AB
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6807141741
    10 mL in 1 BOX (68071-4174-1)

Annotations

UNII (FDA Substance ID)
WI4X0X7BPJ
HYDROCORTISONE
RxCUI 5492
Orange Book
A064053
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": "68071-4174_1a3b96b0-10ac-9bb1-e063-6294a90ab279",
  "productndc": "68071-4174",
  "dosage_form": "SOLUTION/ DROPS",
  "orange_book": {
    "appl_no": "064053",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AT",
        "strength": "1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML",
        "product_no": "001",
        "approval_date": "Dec 29, 1995"
      }
    ],
    "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; [USP'U]/mL",
  "application_number": "ANDA064053",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Neomycin Sulfate, Polymyxin B Sulfate, Hydrocortisone",
  "start_marketing_date": "19951229",
  "active_numerator_strength": "10; 3.5; 10000"
}

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