Acthar
- Product NDC
- 63004-8710
- 11-digit product format
- 630048710
- Labeler code
- 63004
- Product ID
- 63004-8710_f7c33d57-62a6-4791-8d3b-f81ac974ef3c
- 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
- 2026-12-31
- Current FDA listing
- Yes
Orange Book products#
| 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#
| 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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 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… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N008372-003 | ACTHAR GEL (AUTOINJECTOR) | 40 UNITS/0.5ML | INJECTABLE / INJECTION | RLD, RS | 2024-02-29 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N008372-004 | ACTHAR GEL (AUTOINJECTOR) | 80 UNITS/ML | INJECTABLE / INJECTION | RLD, RS | 2024-02-29 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N008372-006 | ACTHAR GEL | 40 UNITS/ML | INJECTABLE / INJECTION | Approved before 1982 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N008372-008 | ACTHAR GEL | 80 UNITS/ML | INJECTABLE / INJECTION | RLD, RS, Approved before 1982 | d8e5a09893c0… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 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… | |
| 2025-08-23 18:47 UTC | 2025-08 | N008372-004 | 11752199 | 2041-07-18 | U-3687 | 2024-07-31 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N008372-004 | 11752199 | 2041-07-18 | U-3688 | 2024-07-31 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N008372-008 | 11752199 | 2041-07-18 | U-3686 | 2023-09-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N008372-008 | 11752199 | 2041-07-18 | U-3687 | 2023-09-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N008372-008 | 11752199 | 2041-07-18 | U-3688 | 2023-09-21 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N008372-003 | 11752199 | 2041-02-25 | U-3686 | 2024-07-31 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N008372-003 | 11752199 | 2041-02-25 | U-3687 | 2024-07-31 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N008372-003 | 11752199 | 2041-02-25 | U-3688 | 2024-07-31 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N008372-004 | 11752199 | 2041-02-25 | U-3686 | 2024-07-31 | fd3edfee7708… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Acthar
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| CORTICOTROPIN | 80 [USP'U]/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| K0U68Q2TXA | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 7b48ddec-e815-45f4-9ca0-5c0daaf56f30 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 7314d8f7-fa99-4dc2-9f68-de2ff142f4b7 | Product name | 2 | 20250121 |
| 2e254488-9fcb-41b3-a7c3-e2c9a3941b29 | Product name | 1 | 20200603 |
| b4ff0805-126a-406d-9cae-fc34fd8e8889 | Product name | 1 | 20190711 |
| 48747306-602a-42cc-957b-5b0c69158eee | Product name | 1 | 20180604 |
| db5ebcdb-b6ae-21cd-4dc5-76cd84b5578b | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| 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 Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63004-8710-1 | ML - Milliliter | 63004-8710 | f5c8b1a1-96a0-4f17-a791-56e95a217fc1 | 1 | 2013-02-13 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| CORTICOTROPIN | ACTIVE INGREDIENT | K0U68Q2TXA | H.P. ACTHAR (REPOSITORY CORTICOTROPIN) INJECTION [MALLINCKRODT ARD INC.] | 3 | |
| CORTICOTROPIN | ACTIVE MOIETY | K0U68Q2TXA | H.P. ACTHAR (REPOSITORY CORTICOTROPIN) INJECTION [MALLINCKRODT ARD INC.] | 3 | |
| ACETIC ACID | INACTIVE INGREDIENT | Q40Q9N063P | H.P. ACTHAR (REPOSITORY CORTICOTROPIN) INJECTION [MALLINCKRODT ARD INC.] | 3 | |
| CYSTEINE | INACTIVE INGREDIENT | K848JZ4886 | H.P. ACTHAR (REPOSITORY CORTICOTROPIN) INJECTION [MALLINCKRODT ARD INC.] | 3 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | H.P. ACTHAR (REPOSITORY CORTICOTROPIN) INJECTION [MALLINCKRODT ARD INC.] | 3 | |
| PHENOL | INACTIVE INGREDIENT | 339NCG44TV | H.P. ACTHAR (REPOSITORY CORTICOTROPIN) INJECTION [MALLINCKRODT ARD INC.] | 3 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | H.P. ACTHAR (REPOSITORY CORTICOTROPIN) INJECTION [MALLINCKRODT ARD INC.] | 3 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | H.P. ACTHAR (REPOSITORY CORTICOTROPIN) INJECTION [MALLINCKRODT ARD INC.] | 3 |
DailyMed Dashboard NDC Coverage#
| 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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Acthar | REPOSITORY CORTICOTROPIN | Mallinckrodt ARD LLC | 7b48ddec-e815-45f4-9ca0-5c0daaf56f30 | 2026-07-15 | Warnings, Adverse reactions | 008372 NDA008372 63004-8710 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2685299 | Acthar Gel 40 UNT in 0.5 ML Prefilled SelfJect Injector | PSN | 7b48ddec-e815-45f4-9ca0-5c0daaf56f30 | 28 |
| 2685296 | Acthar Gel 80 UNT in 1 ML Prefilled SelfJect Injector | PSN | 7b48ddec-e815-45f4-9ca0-5c0daaf56f30 | 28 |
| 1040025 | Acthar H.P. Gel 80 UNT/ML Injectable Solution | PSN | 7b48ddec-e815-45f4-9ca0-5c0daaf56f30 | 28 |
| 2685298 | corticotropin 40 UNT in 0.5 ML Prefilled Self-Controlled Injector | PSN | 7b48ddec-e815-45f4-9ca0-5c0daaf56f30 | 28 |
| 2685293 | corticotropin 80 UNT in 1 ML Prefilled Self-Controlled Injector | PSN | 7b48ddec-e815-45f4-9ca0-5c0daaf56f30 | 28 |
| 309541 | corticotropin 80 UNT/ML Injectable Solution | PSN | 7b48ddec-e815-45f4-9ca0-5c0daaf56f30 | 28 |
| 2685299 | 0.5 ML corticotropin 80 UNT/ML Prefilled Syringe [Acthar] | SBD | 7b48ddec-e815-45f4-9ca0-5c0daaf56f30 | 28 |
| 2685296 | 1 ML corticotropin 80 UNT/ML Prefilled Syringe [Acthar] | SBD | 7b48ddec-e815-45f4-9ca0-5c0daaf56f30 | 28 |
| 1040025 | corticotropin 80 UNT/ML Injectable Solution [Acthar] | SBD | 7b48ddec-e815-45f4-9ca0-5c0daaf56f30 | 28 |
| 2685298 | 0.5 ML corticotropin 80 UNT/ML Prefilled Syringe | SCD | 7b48ddec-e815-45f4-9ca0-5c0daaf56f30 | 28 |
| 2685293 | 1 ML corticotropin 80 UNT/ML Prefilled Syringe | SCD | 7b48ddec-e815-45f4-9ca0-5c0daaf56f30 | 28 |
| 309541 | corticotropin 80 UNT/ML Injectable Solution | SCD | 7b48ddec-e815-45f4-9ca0-5c0daaf56f30 | 28 |
| 2685299 | 0.5 ML Acthar 80 UNT/ML Prefilled Syringe | SY | 7b48ddec-e815-45f4-9ca0-5c0daaf56f30 | 28 |
| 2685296 | 1 ML Acthar 80 UNT/ML Prefilled Syringe | SY | 7b48ddec-e815-45f4-9ca0-5c0daaf56f30 | 28 |
| 1040025 | Acthar 80 UNT/ML Injectable Solution | SY | 7b48ddec-e815-45f4-9ca0-5c0daaf56f30 | 28 |
| 2685299 | Acthar Gel 40 UNT per 0.5 ML Prefilled SelfJect Injector | SY | 7b48ddec-e815-45f4-9ca0-5c0daaf56f30 | 28 |
| 2685296 | Acthar Gel 80 UNT per 1 ML Prefilled SelfJect Injector | SY | 7b48ddec-e815-45f4-9ca0-5c0daaf56f30 | 28 |
| 1040025 | Acthar Gel 80 UNT/ML Injectable Solution | SY | 7b48ddec-e815-45f4-9ca0-5c0daaf56f30 | 28 |
| 2685298 | corticotropin 40 UNT per 0.5 ML Prefilled Self-Controlled Injector | SY | 7b48ddec-e815-45f4-9ca0-5c0daaf56f30 | 28 |
| 309541 | corticotropin 400 UNT per 5 ML Injectable Solution | SY | 7b48ddec-e815-45f4-9ca0-5c0daaf56f30 | 28 |
| 2685293 | corticotropin 80 UNT per 1 ML Prefilled Self-Controlled Injector | SY | 7b48ddec-e815-45f4-9ca0-5c0daaf56f30 | 28 |
Packages#
| 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 |