acthar

Generic: repository corticotropin

Labeler: mallinckrodt ard llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name acthar
Generic Name repository corticotropin
Labeler mallinckrodt ard llc
Dosage Form INJECTION
Routes
INTRAMUSCULAR SUBCUTANEOUS
Active Ingredients

corticotropin 80 [USP'U]/mL

Manufacturer
Mallinckrodt ARD LLC

Identifiers & Regulatory

Product NDC 63004-8710
Product ID 63004-8710_f7c33d57-62a6-4791-8d3b-f81ac974ef3c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA008372
Listing Expiration 2026-12-31
Marketing Start 2013-01-07

Pharmacologic Class

Established (EPC)
adrenocorticotropic hormone [epc]
Chemical Structure
adrenocorticotropic hormone [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 630048710
Hyphenated Format 63004-8710

Supplemental Identifiers

RxCUI
309541 1040025 2685293 2685296 2685298 2685299
UPC
0363004871213
UNII
K0U68Q2TXA
NUI
M0000499 N0000175941

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name acthar (source: ndc)
Generic Name repository corticotropin (source: ndc)
Application Number NDA008372 (source: ndc)
Routes
INTRAMUSCULAR SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 80 [USP'U]/mL
source: ndc
Packaging
  • 1 VIAL, MULTI-DOSE in 1 CARTON (63004-8710-1) / 5 mL in 1 VIAL, MULTI-DOSE
  • 1 VIAL, MULTI-DOSE in 1 CARTON (63004-8710-2) / 5 mL in 1 VIAL, MULTI-DOSE
source: ndc

Packages (2)

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

Ingredients (1)

corticotropin (80 [USP'U]/mL)

Linked Drug Pages (1)

Acthar ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "SUBCUTANEOUS"], "spl_id": "f7c33d57-62a6-4791-8d3b-f81ac974ef3c", "openfda": {"nui": ["M0000499", "N0000175941"], "upc": ["0363004871213"], "unii": ["K0U68Q2TXA"], "rxcui": ["309541", "1040025", "2685293", "2685296", "2685298", "2685299"], "spl_set_id": ["7b48ddec-e815-45f4-9ca0-5c0daaf56f30"], "pharm_class_cs": ["Adrenocorticotropic Hormone [CS]"], "pharm_class_epc": ["Adrenocorticotropic Hormone [EPC]"], "manufacturer_name": ["Mallinckrodt ARD LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, MULTI-DOSE in 1 CARTON (63004-8710-1)  / 5 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "63004-8710-1", "marketing_start_date": "20130107"}, {"sample": true, "description": "1 VIAL, MULTI-DOSE in 1 CARTON (63004-8710-2)  / 5 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "63004-8710-2", "marketing_start_date": "20130107"}], "brand_name": "Acthar", "product_id": "63004-8710_f7c33d57-62a6-4791-8d3b-f81ac974ef3c", "dosage_form": "INJECTION", "pharm_class": ["Adrenocorticotropic Hormone [CS]", "Adrenocorticotropic Hormone [EPC]"], "product_ndc": "63004-8710", "generic_name": "Repository Corticotropin", "labeler_name": "Mallinckrodt ARD LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Acthar", "active_ingredients": [{"name": "CORTICOTROPIN", "strength": "80 [USP'U]/mL"}], "application_number": "NDA008372", "marketing_category": "NDA", "marketing_start_date": "20130107", "listing_expiration_date": "20261231"}