FDA.reportPublic FDA data

Acthar

Product NDC
63004-8711
11-digit product format
630048711
Labeler code
63004
Product ID
63004-8711_f7c33d57-62a6-4791-8d3b-f81ac974ef3c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
repository corticotropin
Dosage form
INJECTION
Route
SUBCUTANEOUS
Labeler
Mallinckrodt ARD LLC
Application
NDA008372
Marketing category
NDA
Marketing start
2024-02-29
Substance
CORTICOTROPIN
Active strength
80 [USP'U]/mL
Pharmacologic classes
Adrenocorticotropic Hormone [CS], Adrenocorticotropic Hormone [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Acthar
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CORTICOTROPIN80 [USP'U]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiK0U68Q2TXA
Rxcui309541, 1040025, 2685293, 2685296, 2685298, 2685299

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7314d8f7-fa99-4dc2-9f68-de2ff142f4b7Product name220250121
2e254488-9fcb-41b3-a7c3-e2c9a3941b29Product name120200603
b4ff0805-126a-406d-9cae-fc34fd8e8889Product name120190711
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63004-8711-1Acthar1 mL in 1 SYRINGEINJECTION128
63004-8711-1Acthar1 in 1 TRAYINJECTION128
63004-8711-4Acthar4 in 1 CARTONINJECTION428

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63004-8711-1ML - Milliliter63004-871143eb32d0-fa7f-4b17-ab49-9a807df0252d12024-07-12
63004-8711-4ML - Milliliter63004-8711265354d4-6981-4a09-8a6b-6991543800b812024-07-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CORTICOTROPINACTIVE INGREDIENTK0U68Q2TXAH.P. ACTHAR (REPOSITORY CORTICOTROPIN) INJECTION [MALLINCKRODT ARD INC.]3
CORTICOTROPINACTIVE MOIETYK0U68Q2TXAH.P. ACTHAR (REPOSITORY CORTICOTROPIN) INJECTION [MALLINCKRODT ARD INC.]3
ACETIC ACIDINACTIVE INGREDIENTQ40Q9N063PH.P. ACTHAR (REPOSITORY CORTICOTROPIN) INJECTION [MALLINCKRODT ARD INC.]3
CYSTEINEINACTIVE INGREDIENTK848JZ4886H.P. ACTHAR (REPOSITORY CORTICOTROPIN) INJECTION [MALLINCKRODT ARD INC.]3
GELATININACTIVE INGREDIENT2G86QN327LH.P. ACTHAR (REPOSITORY CORTICOTROPIN) INJECTION [MALLINCKRODT ARD INC.]3
PHENOLINACTIVE INGREDIENT339NCG44TVH.P. ACTHAR (REPOSITORY CORTICOTROPIN) INJECTION [MALLINCKRODT ARD INC.]3
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IH.P. ACTHAR (REPOSITORY CORTICOTROPIN) INJECTION [MALLINCKRODT ARD INC.]3
WATERINACTIVE INGREDIENT059QF0KO0RH.P. ACTHAR (REPOSITORY CORTICOTROPIN) INJECTION [MALLINCKRODT ARD INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63004-8711ACTHAR (REPOSITORY CORTICOTROPIN) INJECTION ACTHAR (REPOSITORY CORTICOTROPIN) INJECTION [MALLINCKRODT ARD LLC]25Current NDC, 3 package rows20241220_7b48ddec-e815-45f4-9ca0-5c0daaf56f30.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2685299Acthar Gel 40 UNT in 0.5 ML Prefilled SelfJect InjectorPSN7b48ddec-e815-45f4-9ca0-5c0daaf56f3028
2685296Acthar Gel 80 UNT in 1 ML Prefilled SelfJect InjectorPSN7b48ddec-e815-45f4-9ca0-5c0daaf56f3028
1040025Acthar H.P. Gel 80 UNT/ML Injectable SolutionPSN7b48ddec-e815-45f4-9ca0-5c0daaf56f3028
2685298corticotropin 40 UNT in 0.5 ML Prefilled Self-Controlled InjectorPSN7b48ddec-e815-45f4-9ca0-5c0daaf56f3028
2685293corticotropin 80 UNT in 1 ML Prefilled Self-Controlled InjectorPSN7b48ddec-e815-45f4-9ca0-5c0daaf56f3028
309541corticotropin 80 UNT/ML Injectable SolutionPSN7b48ddec-e815-45f4-9ca0-5c0daaf56f3028
26852990.5 ML corticotropin 80 UNT/ML Prefilled Syringe [Acthar]SBD7b48ddec-e815-45f4-9ca0-5c0daaf56f3028
26852961 ML corticotropin 80 UNT/ML Prefilled Syringe [Acthar]SBD7b48ddec-e815-45f4-9ca0-5c0daaf56f3028
1040025corticotropin 80 UNT/ML Injectable Solution [Acthar]SBD7b48ddec-e815-45f4-9ca0-5c0daaf56f3028
26852980.5 ML corticotropin 80 UNT/ML Prefilled SyringeSCD7b48ddec-e815-45f4-9ca0-5c0daaf56f3028
26852931 ML corticotropin 80 UNT/ML Prefilled SyringeSCD7b48ddec-e815-45f4-9ca0-5c0daaf56f3028
309541corticotropin 80 UNT/ML Injectable SolutionSCD7b48ddec-e815-45f4-9ca0-5c0daaf56f3028
26852990.5 ML Acthar 80 UNT/ML Prefilled SyringeSY7b48ddec-e815-45f4-9ca0-5c0daaf56f3028
26852961 ML Acthar 80 UNT/ML Prefilled SyringeSY7b48ddec-e815-45f4-9ca0-5c0daaf56f3028
1040025Acthar 80 UNT/ML Injectable SolutionSY7b48ddec-e815-45f4-9ca0-5c0daaf56f3028
2685299Acthar Gel 40 UNT per 0.5 ML Prefilled SelfJect InjectorSY7b48ddec-e815-45f4-9ca0-5c0daaf56f3028
2685296Acthar Gel 80 UNT per 1 ML Prefilled SelfJect InjectorSY7b48ddec-e815-45f4-9ca0-5c0daaf56f3028
1040025Acthar Gel 80 UNT/ML Injectable SolutionSY7b48ddec-e815-45f4-9ca0-5c0daaf56f3028
2685298corticotropin 40 UNT per 0.5 ML Prefilled Self-Controlled InjectorSY7b48ddec-e815-45f4-9ca0-5c0daaf56f3028
309541corticotropin 400 UNT per 5 ML Injectable SolutionSY7b48ddec-e815-45f4-9ca0-5c0daaf56f3028
2685293corticotropin 80 UNT per 1 ML Prefilled Self-Controlled InjectorSY7b48ddec-e815-45f4-9ca0-5c0daaf56f3028

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
63004-8711-1630048711011 mL in 1 SYRINGE1 mlHistorical
63004-8711-4630048711044 TRAY in 1 CARTON (63004-8711-4) / 1 SYRINGE in 1 TRAY (63004-8711-1) / 1 mL in 1 SYRINGE4 tray2024-02-29NoNoCurrent