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United States · US · US:63481-529_ec1e8a16-a5be-4ff7-a8fe-e0cbfd25aea6

Cortisporin TC

Orange BookUNIISPLATC A07AA

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

Identification

ManufacturerEndo USA, Inc.
CountryUS (United States)
ATC codeA07AA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6348152910
    10 mL in 1 BOTTLE, DROPPER (63481-529-10)

Annotations

UNII (FDA Substance ID)
WP15DXU577
COLISTIN SULFATE
RxCUI 2710
Orange Book
N050356
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "WP15DXU577",
    "rxcui": "2710",
    "inchikey": null,
    "display_name": "COLISTIN SULFATE",
    "substance_type": "mixture",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "AURICULAR (OTIC)",
  "spl_meta": {
    "9c6fc1c7-3350-42ae-b999-aca48e704bb1": {
      "match": "brand_token",
      "title": "CORTISPORIN TC (COLISTIN SULFATE, NEOMYCIN SULFATE, THONZONIUM BROMIDE AND HYDROCORTISONE ACETATE) SUSPENSION [ENDO USA, INC.]",
      "spl_version": "6",
      "published_date": "2025-12-08"
    }
  },
  "productid": "63481-529_ec1e8a16-a5be-4ff7-a8fe-e0cbfd25aea6",
  "productndc": "63481-529",
  "dosage_form": "SUSPENSION",
  "orange_book": {
    "appl_no": "050356",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 3MG BASE/ML;10MG/ML;EQ 3.3MG BASE/ML;0.5MG/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": "COLISTIN SULFATE; HYDROCORTISONE ACETATE; NEOMYCIN SULFATE; THONZONIUM BROMIDE",
  "proprietary_name": "Cortisporin TC",
  "active_ingred_unit": "mg/mL; mg/mL; mg/mL; mg/mL",
  "application_number": "NDA050356",
  "marketing_category": "NDA",
  "nonproprietary_name": "colistin sulfate, neomycin sulfate, thonzonium bromide and hydrocortisone acetate",
  "start_marketing_date": "20190603",
  "active_numerator_strength": "3; 10; 3.3; .5"
}

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