Acthar

Product NDC
63004-8710
11-digit product format
630048710
Labeler code
63004
Product ID
63004-8710_260fcf69-0141-487d-b81a-b91b67b4879a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Repository Corticotropin
Dosage form
INJECTION
Route
INTRAMUSCULAR; SUBCUTANEOUS
Labeler
Keenova ARD LLC
Application
NDA008372
Marketing category
NDA
Marketing start
2013-01-07
Substance
CORTICOTROPIN
Active strength
80 [USP'U]/mL
Pharmacologic classes
Adrenocorticotropic Hormone [CS], Adrenocorticotropic Hormone [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N008372-003ACTHAR GEL (AUTOINJECTOR)CORTICOTROPIN40 UNITS/0.5MLINJECTABLE / INJECTIONRLD, RS2024-02-29
N008372-004ACTHAR GEL (AUTOINJECTOR)CORTICOTROPIN80 UNITS/MLINJECTABLE / INJECTIONRLD, RS2024-02-29
N008372-006ACTHAR GELCORTICOTROPIN40 UNITS/MLINJECTABLE / INJECTIONApproved before 1982
N008372-008ACTHAR GELCORTICOTROPIN80 UNITS/MLINJECTABLE / INJECTIONRLD, RS, Approved before 1982

Orange Book patents#

Current patent rows page 1 of 1 · 9 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N008372-003117521992041-07-18U-36862024-07-31
N008372-003117521992041-07-18U-36872024-07-31
N008372-003117521992041-07-18U-36882024-07-31
N008372-004117521992041-07-18U-36862024-07-31
N008372-004117521992041-07-18U-36872024-07-31
N008372-004117521992041-07-18U-36882024-07-31
N008372-008117521992041-07-18U-36862023-09-21
N008372-008117521992041-07-18U-36872023-09-21
N008372-008117521992041-07-18U-36882023-09-21

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 124 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09N008372-003ACTHAR GEL (AUTOINJECTOR)40 UNITS/0.5MLINJECTABLE / INJECTIONRLD, RS2024-02-29c2088c7a36db…
2026-10-15 13:18:302026-09N008372-004ACTHAR GEL (AUTOINJECTOR)80 UNITS/MLINJECTABLE / INJECTIONRLD, RS2024-02-29c2088c7a36db…
2026-10-15 13:18:302026-09N008372-006ACTHAR GEL40 UNITS/MLINJECTABLE / INJECTIONApproved before 1982c2088c7a36db…
2026-10-15 13:18:302026-09N008372-008ACTHAR GEL80 UNITS/MLINJECTABLE / INJECTIONRLD, RS, Approved before 1982c2088c7a36db…
2026-09-14 22:38:342026-08N008372-003ACTHAR GEL (AUTOINJECTOR)40 UNITS/0.5MLINJECTABLE / INJECTIONRLD, RS2024-02-2984e616aacf4f…
2026-09-14 22:38:342026-08N008372-004ACTHAR GEL (AUTOINJECTOR)80 UNITS/MLINJECTABLE / INJECTIONRLD, RS2024-02-2984e616aacf4f…
2026-09-14 22:38:342026-08N008372-006ACTHAR GEL40 UNITS/MLINJECTABLE / INJECTIONApproved before 198284e616aacf4f…
2026-09-14 22:38:342026-08N008372-008ACTHAR GEL80 UNITS/MLINJECTABLE / INJECTIONRLD, RS, Approved before 198284e616aacf4f…
2026-08-18 06:07:402026-07N008372-003ACTHAR GEL (AUTOINJECTOR)40 UNITS/0.5MLINJECTABLE / INJECTIONRLD, RS2024-02-29caaa826d4ba7…
2026-08-18 06:07:402026-07N008372-004ACTHAR GEL (AUTOINJECTOR)80 UNITS/MLINJECTABLE / INJECTIONRLD, RS2024-02-29caaa826d4ba7…
2026-08-18 06:07:402026-07N008372-006ACTHAR GEL40 UNITS/MLINJECTABLE / INJECTIONApproved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07N008372-008ACTHAR GEL80 UNITS/MLINJECTABLE / INJECTIONRLD, RS, Approved before 1982caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N008372-003ACTHAR GEL (AUTOINJECTOR)40 UNITS/0.5MLINJECTABLE / INJECTIONRLD, RS2024-02-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N008372-004ACTHAR GEL (AUTOINJECTOR)80 UNITS/MLINJECTABLE / INJECTIONRLD, RS2024-02-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N008372-006ACTHAR GEL40 UNITS/MLINJECTABLE / INJECTIONApproved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N008372-008ACTHAR GEL80 UNITS/MLINJECTABLE / INJECTIONRLD, RS, Approved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N008372-003ACTHAR GEL (AUTOINJECTOR)40 UNITS/0.5MLINJECTABLE / INJECTIONRLD, RS2024-02-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N008372-004ACTHAR GEL (AUTOINJECTOR)80 UNITS/MLINJECTABLE / INJECTIONRLD, RS2024-02-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N008372-006ACTHAR GEL40 UNITS/MLINJECTABLE / INJECTIONApproved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N008372-008ACTHAR GEL80 UNITS/MLINJECTABLE / INJECTIONRLD, RS, Approved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08N008372-003ACTHAR GEL (AUTOINJECTOR)40 UNITS/0.5MLINJECTABLE / INJECTIONRLD, RS2024-02-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N008372-004ACTHAR GEL (AUTOINJECTOR)80 UNITS/MLINJECTABLE / INJECTIONRLD, RS2024-02-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N008372-006ACTHAR GEL40 UNITS/MLINJECTABLE / INJECTIONApproved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N008372-008ACTHAR GEL80 UNITS/MLINJECTABLE / INJECTIONRLD, RS, Approved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N008372-003ACTHAR GEL (AUTOINJECTOR)40 UNITS/0.5MLINJECTABLE / INJECTIONRLD, RS2024-02-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N008372-004ACTHAR GEL (AUTOINJECTOR)80 UNITS/MLINJECTABLE / INJECTIONRLD, RS2024-02-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N008372-006ACTHAR GEL40 UNITS/MLINJECTABLE / INJECTIONApproved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N008372-008ACTHAR GEL80 UNITS/MLINJECTABLE / INJECTIONRLD, RS, Approved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N008372-003ACTHAR GEL (AUTOINJECTOR)40 UNITS/0.5MLINJECTABLE / INJECTIONRLD, RS2024-02-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N008372-004ACTHAR GEL (AUTOINJECTOR)80 UNITS/MLINJECTABLE / INJECTIONRLD, RS2024-02-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N008372-006ACTHAR GEL40 UNITS/MLINJECTABLE / INJECTIONApproved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N008372-008ACTHAR GEL80 UNITS/MLINJECTABLE / INJECTIONRLD, RS, Approved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N008372-003ACTHAR GEL (AUTOINJECTOR)40 UNITS/0.5MLINJECTABLE / INJECTIONRLD, RS2024-02-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N008372-004ACTHAR GEL (AUTOINJECTOR)80 UNITS/MLINJECTABLE / INJECTIONRLD, RS2024-02-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N008372-006ACTHAR GEL40 UNITS/MLINJECTABLE / INJECTIONApproved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N008372-008ACTHAR GEL80 UNITS/MLINJECTABLE / INJECTIONRLD, RS, Approved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N008372-003ACTHAR GEL (AUTOINJECTOR)40 UNITS/0.5MLINJECTABLE / INJECTIONRLD, RS2024-02-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N008372-004ACTHAR GEL (AUTOINJECTOR)80 UNITS/MLINJECTABLE / INJECTIONRLD, RS2024-02-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N008372-006ACTHAR GEL40 UNITS/MLINJECTABLE / INJECTIONApproved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N008372-008ACTHAR GEL80 UNITS/MLINJECTABLE / INJECTIONRLD, RS, Approved before 19822680178bc6a6…

Observed Orange Book patent history#

Patent history page 1 of 4 · 159 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-10-15 13:18:302026-09N008372-003117521992041-07-18U-36862024-07-31c2088c7a36db…
2026-10-15 13:18:302026-09N008372-003117521992041-07-18U-36872024-07-31c2088c7a36db…
2026-10-15 13:18:302026-09N008372-003117521992041-07-18U-36882024-07-31c2088c7a36db…
2026-10-15 13:18:302026-09N008372-004117521992041-07-18U-36862024-07-31c2088c7a36db…
2026-10-15 13:18:302026-09N008372-004117521992041-07-18U-36872024-07-31c2088c7a36db…
2026-10-15 13:18:302026-09N008372-004117521992041-07-18U-36882024-07-31c2088c7a36db…
2026-10-15 13:18:302026-09N008372-008117521992041-07-18U-36862023-09-21c2088c7a36db…
2026-10-15 13:18:302026-09N008372-008117521992041-07-18U-36872023-09-21c2088c7a36db…
2026-10-15 13:18:302026-09N008372-008117521992041-07-18U-36882023-09-21c2088c7a36db…
2026-09-14 22:38:342026-08N008372-003117521992041-07-18U-36862024-07-3184e616aacf4f…
2026-09-14 22:38:342026-08N008372-003117521992041-07-18U-36872024-07-3184e616aacf4f…
2026-09-14 22:38:342026-08N008372-003117521992041-07-18U-36882024-07-3184e616aacf4f…
2026-09-14 22:38:342026-08N008372-004117521992041-07-18U-36862024-07-3184e616aacf4f…
2026-09-14 22:38:342026-08N008372-004117521992041-07-18U-36872024-07-3184e616aacf4f…
2026-09-14 22:38:342026-08N008372-004117521992041-07-18U-36882024-07-3184e616aacf4f…
2026-09-14 22:38:342026-08N008372-008117521992041-07-18U-36862023-09-2184e616aacf4f…
2026-09-14 22:38:342026-08N008372-008117521992041-07-18U-36872023-09-2184e616aacf4f…
2026-09-14 22:38:342026-08N008372-008117521992041-07-18U-36882023-09-2184e616aacf4f…
2026-08-18 06:07:402026-07N008372-003117521992041-07-18U-36862024-07-31caaa826d4ba7…
2026-08-18 06:07:402026-07N008372-003117521992041-07-18U-36872024-07-31caaa826d4ba7…
2026-08-18 06:07:402026-07N008372-003117521992041-07-18U-36882024-07-31caaa826d4ba7…
2026-08-18 06:07:402026-07N008372-004117521992041-07-18U-36862024-07-31caaa826d4ba7…
2026-08-18 06:07:402026-07N008372-004117521992041-07-18U-36872024-07-31caaa826d4ba7…
2026-08-18 06:07:402026-07N008372-004117521992041-07-18U-36882024-07-31caaa826d4ba7…
2026-08-18 06:07:402026-07N008372-008117521992041-07-18U-36862023-09-21caaa826d4ba7…
2026-08-18 06:07:402026-07N008372-008117521992041-07-18U-36872023-09-21caaa826d4ba7…
2026-08-18 06:07:402026-07N008372-008117521992041-07-18U-36882023-09-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N008372-003117521992041-07-18U-36862024-07-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02N008372-003117521992041-07-18U-36872024-07-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02N008372-003117521992041-07-18U-36882024-07-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02N008372-004117521992041-07-18U-36862024-07-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02N008372-004117521992041-07-18U-36872024-07-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02N008372-004117521992041-07-18U-36882024-07-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02N008372-008117521992041-07-18U-36862023-09-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N008372-008117521992041-07-18U-36872023-09-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N008372-008117521992041-07-18U-36882023-09-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N008372-003117521992041-07-18U-36862024-07-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N008372-003117521992041-07-18U-36872024-07-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N008372-003117521992041-07-18U-36882024-07-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N008372-004117521992041-07-18U-36862024-07-3131067a03dcf5…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Acthar
Listing expiration
2027-12-31

Active Ingredients#

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

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
63004-8710-1Acthar1 in 1 CARTONINJECTION128
63004-8710-1Acthar5 mL in 1 VIAL, MULTI-DOSEINJECTION528
63004-8710-2Acthar5 mL in 1 VIAL, MULTI-DOSEINJECTION528
63004-8710-2Acthar1 in 1 CARTONINJECTION128

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63004-8710-1ML - Milliliter63004-8710f5c8b1a1-96a0-4f17-a791-56e95a217fc112013-02-13

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63004-8710ACTHAR (REPOSITORY CORTICOTROPIN) INJECTION ACTHAR (REPOSITORY CORTICOTROPIN) INJECTION [MALLINCKRODT ARD LLC]25Current NDC, Legacy NDC, 4 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 formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63004-8710-1630048710011 VIAL, MULTI-DOSE in 1 CARTON (63004-8710-1) / 5 mL in 1 VIAL, MULTI-DOSE2013-01-070000-00-00NoNoCurrent
63004-8710-2630048710021 VIAL, MULTI-DOSE in 1 CARTON (63004-8710-2) / 5 mL in 1 VIAL, MULTI-DOSE2013-01-070000-00-00YesNoCurrent
63004-8710-3630048710031 VIAL, MULTI-DOSE in 1 CARTON (63004-8710-3) > 5 mL in 1 VIAL, MULTI-DOSE2013-01-070000-00-00NoNoCurrent