Home NDC 63004-8710 Acthar
Product NDC 63004-8710
11-digit product format 630048710
Labeler code 63004
Product ID 63004-8710_c63a790c-ec8a-4037-bbd3-cfe75cdd81ab
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Repository Corticotropin
Dosage form INJECTION
Route INTRAMUSCULAR; SUBCUTANEOUS
Labeler Mallinckrodt 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 43 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N008372-003 ACTHAR GEL (AUTOINJECTOR) CORTICOTROPIN 40 UNITS/0.5ML INJECTABLE / INJECTION RLD, RS 2024-02-29 N008372-004 ACTHAR GEL (AUTOINJECTOR) CORTICOTROPIN 80 UNITS/ML INJECTABLE / INJECTION RLD, RS 2024-02-29 N008372-006 ACTHAR GEL CORTICOTROPIN 40 UNITS/ML INJECTABLE / INJECTION Approved before 1982 N008372-008 ACTHAR GEL CORTICOTROPIN 80 UNITS/ML INJECTABLE / INJECTION RLD, RS, Approved before 1982
Orange Book patents# Current patent rows page 1 of 1 · 9 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N008372-003 11752199 2041-07-18 U-3686 2024-07-31 N008372-003 11752199 2041-07-18 U-3687 2024-07-31 N008372-003 11752199 2041-07-18 U-3688 2024-07-31 N008372-004 11752199 2041-07-18 U-3686 2024-07-31 N008372-004 11752199 2041-07-18 U-3687 2024-07-31 N008372-004 11752199 2041-07-18 U-3688 2024-07-31 N008372-008 11752199 2041-07-18 U-3686 2023-09-21 N008372-008 11752199 2041-07-18 U-3687 2023-09-21 N008372-008 11752199 2041-07-18 U-3688 2023-09-21
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 3 · 120 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 N008372-003 ACTHAR GEL (AUTOINJECTOR) 40 UNITS/0.5ML INJECTABLE / INJECTION RLD, RS 2024-02-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N008372-004 ACTHAR GEL (AUTOINJECTOR) 80 UNITS/ML INJECTABLE / INJECTION RLD, RS 2024-02-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N008372-006 ACTHAR GEL 40 UNITS/ML INJECTABLE / INJECTION Approved before 1982 84e616aacf4f…2026-09-14 22:38:34 2026-08 N008372-008 ACTHAR GEL 80 UNITS/ML INJECTABLE / INJECTION RLD, RS, Approved before 1982 84e616aacf4f…2026-08-18 06:07:40 2026-07 N008372-003 ACTHAR GEL (AUTOINJECTOR) 40 UNITS/0.5ML INJECTABLE / INJECTION RLD, RS 2024-02-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N008372-004 ACTHAR GEL (AUTOINJECTOR) 80 UNITS/ML INJECTABLE / INJECTION RLD, RS 2024-02-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N008372-006 ACTHAR GEL 40 UNITS/ML INJECTABLE / INJECTION Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N008372-008 ACTHAR GEL 80 UNITS/ML INJECTABLE / INJECTION RLD, RS, Approved before 1982 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N008372-003 ACTHAR GEL (AUTOINJECTOR) 40 UNITS/0.5ML INJECTABLE / INJECTION RLD, RS 2024-02-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N008372-004 ACTHAR GEL (AUTOINJECTOR) 80 UNITS/ML INJECTABLE / INJECTION RLD, RS 2024-02-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N008372-006 ACTHAR GEL 40 UNITS/ML INJECTABLE / INJECTION Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N008372-008 ACTHAR GEL 80 UNITS/ML INJECTABLE / INJECTION RLD, RS, Approved before 1982 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N008372-003 ACTHAR GEL (AUTOINJECTOR) 40 UNITS/0.5ML INJECTABLE / INJECTION RLD, RS 2024-02-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N008372-004 ACTHAR GEL (AUTOINJECTOR) 80 UNITS/ML INJECTABLE / INJECTION RLD, RS 2024-02-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N008372-006 ACTHAR GEL 40 UNITS/ML INJECTABLE / INJECTION Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N008372-008 ACTHAR GEL 80 UNITS/ML INJECTABLE / INJECTION RLD, RS, Approved before 1982 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N008372-003 ACTHAR GEL (AUTOINJECTOR) 40 UNITS/0.5ML INJECTABLE / INJECTION RLD, RS 2024-02-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N008372-004 ACTHAR GEL (AUTOINJECTOR) 80 UNITS/ML INJECTABLE / INJECTION RLD, RS 2024-02-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N008372-006 ACTHAR GEL 40 UNITS/ML INJECTABLE / INJECTION Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N008372-008 ACTHAR GEL 80 UNITS/ML INJECTABLE / INJECTION RLD, RS, Approved before 1982 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N008372-003 ACTHAR GEL (AUTOINJECTOR) 40 UNITS/0.5ML INJECTABLE / INJECTION RLD, RS 2024-02-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N008372-004 ACTHAR GEL (AUTOINJECTOR) 80 UNITS/ML INJECTABLE / INJECTION RLD, RS 2024-02-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N008372-006 ACTHAR GEL 40 UNITS/ML INJECTABLE / INJECTION Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N008372-008 ACTHAR GEL 80 UNITS/ML INJECTABLE / INJECTION RLD, RS, Approved before 1982 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N008372-003 ACTHAR GEL (AUTOINJECTOR) 40 UNITS/0.5ML INJECTABLE / INJECTION RLD, RS 2024-02-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N008372-004 ACTHAR GEL (AUTOINJECTOR) 80 UNITS/ML INJECTABLE / INJECTION RLD, RS 2024-02-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N008372-006 ACTHAR GEL 40 UNITS/ML INJECTABLE / INJECTION Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N008372-008 ACTHAR GEL 80 UNITS/ML INJECTABLE / INJECTION RLD, RS, Approved before 1982 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N008372-003 ACTHAR GEL (AUTOINJECTOR) 40 UNITS/0.5ML INJECTABLE / INJECTION RLD, RS 2024-02-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N008372-004 ACTHAR GEL (AUTOINJECTOR) 80 UNITS/ML INJECTABLE / INJECTION RLD, RS 2024-02-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N008372-006 ACTHAR GEL 40 UNITS/ML INJECTABLE / INJECTION Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N008372-008 ACTHAR GEL 80 UNITS/ML INJECTABLE / INJECTION RLD, RS, Approved before 1982 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N008372-003 ACTHAR GEL (AUTOINJECTOR) 40 UNITS/0.5ML INJECTABLE / INJECTION RLD, RS 2024-02-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N008372-004 ACTHAR GEL (AUTOINJECTOR) 80 UNITS/ML INJECTABLE / INJECTION RLD, RS 2024-02-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N008372-006 ACTHAR GEL 40 UNITS/ML INJECTABLE / INJECTION Approved before 1982 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N008372-008 ACTHAR GEL 80 UNITS/ML INJECTABLE / INJECTION RLD, RS, Approved before 1982 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N008372-003 ACTHAR GEL (AUTOINJECTOR) 40 UNITS/0.5ML INJECTABLE / INJECTION RLD, RS 2024-02-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N008372-004 ACTHAR GEL (AUTOINJECTOR) 80 UNITS/ML INJECTABLE / INJECTION RLD, RS 2024-02-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N008372-006 ACTHAR GEL 40 UNITS/ML INJECTABLE / INJECTION Approved before 1982 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N008372-008 ACTHAR GEL 80 UNITS/ML INJECTABLE / INJECTION RLD, RS, Approved before 1982 5bbf6a4d5a75…
Observed Orange Book patent history# Patent history page 1 of 4 · 150 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N008372-003 11752199 2041-07-18 U-3686 2024-07-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 N008372-003 11752199 2041-07-18 U-3687 2024-07-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 N008372-003 11752199 2041-07-18 U-3688 2024-07-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 N008372-004 11752199 2041-07-18 U-3686 2024-07-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 N008372-004 11752199 2041-07-18 U-3687 2024-07-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 N008372-004 11752199 2041-07-18 U-3688 2024-07-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 N008372-008 11752199 2041-07-18 U-3686 2023-09-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N008372-008 11752199 2041-07-18 U-3687 2023-09-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N008372-008 11752199 2041-07-18 U-3688 2023-09-21 84e616aacf4f…2026-08-18 06:07:40 2026-07 N008372-003 11752199 2041-07-18 U-3686 2024-07-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N008372-003 11752199 2041-07-18 U-3687 2024-07-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N008372-003 11752199 2041-07-18 U-3688 2024-07-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N008372-004 11752199 2041-07-18 U-3686 2024-07-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N008372-004 11752199 2041-07-18 U-3687 2024-07-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N008372-004 11752199 2041-07-18 U-3688 2024-07-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N008372-008 11752199 2041-07-18 U-3686 2023-09-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N008372-008 11752199 2041-07-18 U-3687 2023-09-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N008372-008 11752199 2041-07-18 U-3688 2023-09-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N008372-003 11752199 2041-07-18 U-3686 2024-07-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N008372-003 11752199 2041-07-18 U-3687 2024-07-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N008372-003 11752199 2041-07-18 U-3688 2024-07-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N008372-004 11752199 2041-07-18 U-3686 2024-07-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N008372-004 11752199 2041-07-18 U-3687 2024-07-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N008372-004 11752199 2041-07-18 U-3688 2024-07-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N008372-008 11752199 2041-07-18 U-3686 2023-09-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N008372-008 11752199 2041-07-18 U-3687 2023-09-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N008372-008 11752199 2041-07-18 U-3688 2023-09-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N008372-003 11752199 2041-07-18 U-3686 2024-07-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N008372-003 11752199 2041-07-18 U-3687 2024-07-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N008372-003 11752199 2041-07-18 U-3688 2024-07-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N008372-004 11752199 2041-07-18 U-3686 2024-07-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N008372-004 11752199 2041-07-18 U-3687 2024-07-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N008372-004 11752199 2041-07-18 U-3688 2024-07-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N008372-008 11752199 2041-07-18 U-3686 2023-09-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N008372-008 11752199 2041-07-18 U-3687 2023-09-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N008372-008 11752199 2041-07-18 U-3688 2023-09-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N008372-003 11752199 2041-07-18 U-3686 2024-07-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N008372-003 11752199 2041-07-18 U-3687 2024-07-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N008372-003 11752199 2041-07-18 U-3688 2024-07-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N008372-004 11752199 2041-07-18 U-3686 2024-07-31 6a471c1ec25d…
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 Ingredient Strength CORTICOTROPIN 80 [USP'U]/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination K0U68Q2TXA Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 309541 Internal RxNorm lookup 1040025 Internal RxNorm lookup 2685293 Internal RxNorm lookup 2685296 Internal RxNorm lookup 2685298 Internal RxNorm lookup 2685299 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63004-8710-1 Acthar 1 in 1 CARTON INJECTION 1 28 63004-8710-1 Acthar 5 mL in 1 VIAL, MULTI-DOSE INJECTION 5 28 63004-8710-2 Acthar 5 mL in 1 VIAL, MULTI-DOSE INJECTION 5 28 63004-8710-2 Acthar 1 in 1 CARTON INJECTION 1 28
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63004-8710 ACTHAR (REPOSITORY CORTICOTROPIN) INJECTION ACTHAR (REPOSITORY CORTICOTROPIN) INJECTION [MALLINCKRODT ARD LLC] 25 Current NDC, Legacy NDC, 4 package rows 20241220_7b48ddec-e815-45f4-9ca0-5c0daaf56f30.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 63004-8710-1 63004871001 1 VIAL, MULTI-DOSE in 1 CARTON (63004-8710-1) / 5 mL in 1 VIAL, MULTI-DOSE 2013-01-07 0000-00-00 No No Current 63004-8710-2 63004871002 1 VIAL, MULTI-DOSE in 1 CARTON (63004-8710-2) / 5 mL in 1 VIAL, MULTI-DOSE 2013-01-07 0000-00-00 Yes No Current 63004-8710-3 63004871003 1 VIAL, MULTI-DOSE in 1 CARTON (63004-8710-3) > 5 mL in 1 VIAL, MULTI-DOSE 2013-01-07 0000-00-00 No No Current