NDC 63004-8710

Acthar

Repository Corticotropin

Acthar is a Intramuscular; Subcutaneous Injection in the Human Prescription Drug category. It is labeled and distributed by Mallinckrodt Ard Llc. The primary component is Corticotropin.

• Product ID: 63004-8710_1716c3dd-83e8-4ec0-91d2-965e54b04f6f
• NDC: 63004-8710
• Product Type: Human Prescription Drug
• Proprietary Name: Acthar
• Generic Name: Repository Corticotropin
• Dosage Form: Injection
• Route of Administration: INTRAMUSCULAR; SUBCUTANEOUS
• Marketing Start Date: 2013-01-07
• Marketing Category: NDA / NDA
• Application Number: NDA022432
• Labeler Name: Mallinckrodt ARD LLC
• Substance Name: CORTICOTROPIN
• Active Ingredient Strength: 80 [USP'U]/mL
• Pharm Classes: Adrenocorticotropic Hormone [CS],Adrenocorticotropic Hormone [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 63004-8710-1

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

• Marketing Start Date: 2013-01-07
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 63004-8710-2 [63004871002]

Acthar INJECTION

• Marketing Category: NDA
• Application Number: NDA022432
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2013-01-07

NDC 63004-8710-1 [63004871001]

Acthar INJECTION

• Marketing Category: NDA
• Application Number: NDA022432
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2013-01-07

NDC 63004-8710-3 [63004871003]

Acthar INJECTION

• Marketing Category: NDA
• Application Number: NDA022432
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2013-01-07

Drug Details

Pharmacological Class

• Adrenocorticotropic Hormone [CS]
• Adrenocorticotropic Hormone [EPC]

NDC Crossover Matching brand name "Acthar" or generic name "Repository Corticotropin"

NDC	Brand Name	Generic Name
63004-8710	Acthar	Repository Corticotropin
62559-860	Purified Cortrophin Gel	Repository Corticotropin