Purified Cortrophin Gel

Orange BookUNIISPLATC H01AA01

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

Identification

ManufacturerANI Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeH01AA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
6255986111
1 SYRINGE, GLASS in 1 CARTON (62559-861-11) / 1 mL in 1 SYRINGE, GLASS
ndc11
6255986135
1 SYRINGE, GLASS in 1 CARTON (62559-861-35) / .5 mL in 1 SYRINGE, GLASS

Annotations

UNII (FDA Substance ID)

K0U68Q2TXA

CORTICOTROPIN

RxCUI 376

Orange Book

N008975

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "K0U68Q2TXA",
    "rxcui": "376",
    "inchikey": null,
    "display_name": "CORTICOTROPIN",
    "substance_type": "protein",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "SUBCUTANEOUS",
  "spl_meta": {
    "f27544ee-a0e2-4d84-b193-1c9efdf9e34c": {
      "match": "brand_token",
      "title": "PURIFIED CORTROPHIN GEL (REPOSITORY CORTICOTROPIN) INJECTION [ANI PHARMACEUTICALS, INC.]",
      "spl_version": "14",
      "published_date": "2026-02-10"
    }
  },
  "productid": "62559-861_acbfd15f-c384-4b64-b444-33952abc3566",
  "productndc": "62559-861",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "008975",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "40 UNITS/ML",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "80 UNITS/ML",
        "product_no": "002",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CORTICOTROPIN",
  "proprietary_name": "Purified Cortrophin Gel",
  "active_ingred_unit": "[USP'U]/mL",
  "application_number": "NDA008975",
  "marketing_category": "NDA",
  "nonproprietary_name": "Repository Corticotropin",
  "start_marketing_date": "20250228",
  "active_numerator_strength": "80"
}

Related drugs

Other records sharing ATC code H01AA01.

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