Acthar

Orange BookUNIISPLATC H01AA01

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

Identification

ManufacturerMallinckrodt ARD LLC

CountryUS (United States)

ATC codeH01AA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
6300487101
1 VIAL, MULTI-DOSE in 1 CARTON (63004-8710-1) / 5 mL in 1 VIAL, MULTI-DOSE
ndc11
6300487102
1 VIAL, MULTI-DOSE in 1 CARTON (63004-8710-2) / 5 mL in 1 VIAL, MULTI-DOSE

Annotations

UNII (FDA Substance ID)

K0U68Q2TXA

CORTICOTROPIN

RxCUI 376

Orange Book

N008372

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": "INTRAMUSCULAR; SUBCUTANEOUS",
  "spl_meta": {
    "7b48ddec-e815-45f4-9ca0-5c0daaf56f30": {
      "match": "brand_token",
      "title": "ACTHAR (REPOSITORY CORTICOTROPIN) INJECTION ACTHAR (REPOSITORY CORTICOTROPIN) INJECTION [MALLINCKRODT ARD LLC]",
      "spl_version": "28",
      "published_date": "2025-12-08"
    }
  },
  "productid": "63004-8710_f7c33d57-62a6-4791-8d3b-f81ac974ef3c",
  "productndc": "63004-8710",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "008372",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "40 UNITS/0.5ML",
        "product_no": "003",
        "approval_date": "Feb 29, 2024"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "80 UNITS/ML",
        "product_no": "004",
        "approval_date": "Feb 29, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "40 UNITS/ML",
        "product_no": "006",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "80 UNITS/ML",
        "product_no": "008",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CORTICOTROPIN",
  "proprietary_name": "Acthar",
  "active_ingred_unit": "[USP'U]/mL",
  "application_number": "NDA008372",
  "marketing_category": "NDA",
  "nonproprietary_name": "Repository Corticotropin",
  "start_marketing_date": "20130107",
  "active_numerator_strength": "80"
}

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