Neomycin and Polymyxin B Sulfates and Hydrocortisone

Orange BookUNIISPLATC D07AB

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerSandoz Inc.

CountryUS (United States)

ATC codeD07AB

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6131464511
10 mL in 1 BOTTLE, PLASTIC (61314-645-11)

Annotations

UNII (FDA Substance ID)

WI4X0X7BPJ

HYDROCORTISONE

RxCUI 5492

Orange Book

A062488

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": "61314-645_99d0c7c1-3bf0-4491-b093-551555f7e80c",
  "productndc": "61314-645",
  "dosage_form": "SUSPENSION",
  "orange_book": {
    "appl_no": "062488",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AT",
        "strength": "1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML",
        "product_no": "001",
        "approval_date": "Nov 6, 1985"
      }
    ],
    "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": "ANDA062488",
  "marketing_category": "ANDA",
  "nonproprietary_name": "neomycin sulfate, polymyxin b sulfate and hydrocortisone",
  "start_marketing_date": "20030317",
  "active_numerator_strength": "10; 3.5; 10000"
}

Related drugs

Other records sharing ATC code D07AB.

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