Humira
- Product NDC
- 0074-6347
- 11-digit product format
- 000746347
- Labeler code
- 0074
- Product ID
- 0074-6347_7a967019-f452-7b99-ba3d-e9b3ac703363
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Adalimumab
- Dosage form
- KIT
- Labeler
- AbbVie Inc.
- Application
- BLA125057
- Marketing category
- BLA
- Marketing start
- 2014-09-23
- Marketing end
- 2021-01-31
- Active strength
- 0
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 0074-6347 | D | Discontinued by firm | 2026-10-05 | ||
| excluded package | package | 0074-6347 | 0074-6347-02 | D | Discontinued by firm | 2026-10-05 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 0074-6347-02 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 0074-6347-02 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 0074-6347-02 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 0074-6347-02 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 0074-6347-02 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 0074-6347-02 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 0074-6347-02 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 0074-6347-02 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 0074-6347-02 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 0074-6347-02 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 0074-6347-02 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 0074-6347-02 | 557ba5c1ecfa… | 9c80585c8c6e… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 58819a18-327d-463b-9e5e-26cc1dd9870d | Product name | 1 | 20230313 |
| c1c5a070-0e2e-43dd-af9c-a21585200342 | Product name | 1 | 20230104 |
| 2a463079-cd68-4798-a3d6-55c4c8578d57 | Product name | 1 | 20220728 |
| 652f8f6b-479d-477c-848a-374d5b0145b7 | Product name | 2 | 20151203 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0074-6347-02 | EA - Each | 0074-6347 | 525982ce-ff09-435b-aa1b-7ee6526a96f0 | 1 | 2014-11-05 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
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 |
|---|---|---|---|---|---|---|
| Humira | ADALIMUMAB | Cordavis Limited | 4977567e-3525-44ac-9ff5-f1e74b053950 | 2025-12-23 | Boxed warning, Warnings, Adverse reactions | BLA125057 |
| Humira | ADALIMUMAB | AbbVie Inc. | 608d4f0d-b19f-46d3-749a-7159aa5f933d | 2025-12-23 | Boxed warning, Warnings, Adverse reactions | BLA125057 |
| HUMIRA | ADALIMUMAB | A-S Medication Solutions | a06a9aec-fd5b-4c3e-a81f-eb46bb384100 | 2024-05-16 | Boxed warning, Warnings, Adverse reactions | BLA125057 |
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 125057 | Humira | adalimumab | 351(a) | Rx | 2026-09-01 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1855527 | {1 (0.4 ML adalimumab 100 MG/ML Prefilled Syringe [Humira]) / 1 (0.8 ML adalimumab 100 MG/ML Prefilled Syringe [Humira]) } Pack [Humira Pediatric Crohn's Disease Starter Package (2 count)] | BPCK | 608d4f0d-b19f-46d3-749a-7159aa5f933d | 2154 |
| 1921468 | {2 (0.4 ML adalimumab 100 MG/ML Auto-Injector [Humira]) / 1 (0.8 ML adalimumab 100 MG/ML Auto-Injector [Humira]) } Pack [Humira Pen 80 MG/0.8 ML and 40 MG/0.4 ML - Psoriasis/Uveitis Starter Package] | BPCK | 608d4f0d-b19f-46d3-749a-7159aa5f933d | 2154 |
| 1921245 | {3 (0.8 ML adalimumab 100 MG/ML Auto-Injector [Humira]) } Pack [Humira Pen 80 MG/0.8 ML - Starter Package for Crohn's Disease, Ulcerative Colitis or Hidradenitis Suppurativa] | BPCK | 608d4f0d-b19f-46d3-749a-7159aa5f933d | 2154 |
| 1873087 | {3 (0.8 ML adalimumab 100 MG/ML Prefilled Syringe [Humira]) } Pack [Humira Prefilled Syringe 80 MG/0.8 ML Starter Pack - Pediatric Crohn's Disease] | BPCK | 608d4f0d-b19f-46d3-749a-7159aa5f933d | 2154 |
| 1594358 | {3 (0.8 ML adalimumab 50 MG/ML Prefilled Syringe [Humira]) } Pack [Humira Pediatric Crohn's Disease Starter Package (3 count)] | BPCK | 608d4f0d-b19f-46d3-749a-7159aa5f933d | 2154 |
| 1872986 | {4 (0.4 ML adalimumab 100 MG/ML Auto-Injector [Humira]) } Pack [Humira Pen 40 MG/0.4 ML Starter Pack - Psoriasis] | BPCK | 608d4f0d-b19f-46d3-749a-7159aa5f933d | 2154 |
| 2531134 | {4 (0.8 ML adalimumab 100 MG/ML Auto-Injector [Humira]) } Pack [Humira Pen 80 MG/0.8 ML - Starter Package for Pediatric Ulcerative Colitis] | BPCK | 608d4f0d-b19f-46d3-749a-7159aa5f933d | 2154 |
| 1801278 | {4 (0.8 ML adalimumab 50 MG/ML Auto-Injector [Humira]) } Pack [Humira Pen - Psoriasis Starter Pack] | BPCK | 608d4f0d-b19f-46d3-749a-7159aa5f933d | 2154 |
| 1872984 | {6 (0.4 ML adalimumab 100 MG/ML Auto-Injector [Humira]) } Pack [Humira Pen 40 MG/0.4 ML Starter Pack - Crohn's Disease] | BPCK | 608d4f0d-b19f-46d3-749a-7159aa5f933d | 2154 |
| 825170 | {6 (0.8 ML adalimumab 50 MG/ML Auto-Injector [Humira]) } Pack [Humira Pen - Crohn's Disease Starter Pack] | BPCK | 608d4f0d-b19f-46d3-749a-7159aa5f933d | 2154 |
| 1594352 | {6 (0.8 ML adalimumab 50 MG/ML Prefilled Syringe [Humira]) } Pack [Humira Pediatric Crohn's Disease Starter Package (6 count)] | BPCK | 608d4f0d-b19f-46d3-749a-7159aa5f933d | 2154 |
| 1855526 | {1 (0.4 ML adalimumab 100 MG/ML Prefilled Syringe) / 1 (0.8 ML adalimumab 100 MG/ML Prefilled Syringe) } Pack | GPCK | 608d4f0d-b19f-46d3-749a-7159aa5f933d | 2154 |
| 1921467 | {2 (0.4 ML adalimumab 100 MG/ML Auto-Injector) / 1 (0.8 ML adalimumab 100 MG/ML Auto-Injector) } Pack | GPCK | 608d4f0d-b19f-46d3-749a-7159aa5f933d | 2154 |
| 1921244 | {3 (0.8 ML adalimumab 100 MG/ML Auto-Injector) } Pack | GPCK | 608d4f0d-b19f-46d3-749a-7159aa5f933d | 2154 |
| 1873086 | {3 (0.8 ML adalimumab 100 MG/ML Prefilled Syringe) } Pack | GPCK | 608d4f0d-b19f-46d3-749a-7159aa5f933d | 2154 |
| 1594357 | {3 (0.8 ML adalimumab 50 MG/ML Prefilled Syringe) } Pack | GPCK | 608d4f0d-b19f-46d3-749a-7159aa5f933d | 2154 |
| 1872985 | {4 (0.4 ML adalimumab 100 MG/ML Auto-Injector) } Pack | GPCK | 608d4f0d-b19f-46d3-749a-7159aa5f933d | 2154 |
| 2531133 | {4 (0.8 ML adalimumab 100 MG/ML Auto-Injector) } Pack | GPCK | 608d4f0d-b19f-46d3-749a-7159aa5f933d | 2154 |
| 1801277 | {4 (0.8 ML adalimumab 50 MG/ML Auto-Injector) } Pack | GPCK | 608d4f0d-b19f-46d3-749a-7159aa5f933d | 2154 |
| 1872983 | {6 (0.4 ML adalimumab 100 MG/ML Auto-Injector) } Pack | GPCK | 608d4f0d-b19f-46d3-749a-7159aa5f933d | 2154 |
| 1656703 | {6 (0.8 ML adalimumab 50 MG/ML Auto-Injector) } Pack | GPCK | 608d4f0d-b19f-46d3-749a-7159aa5f933d | 2154 |
| 825169 | {6 (0.8 ML adalimumab 50 MG/ML Prefilled Syringe) } Pack | GPCK | 608d4f0d-b19f-46d3-749a-7159aa5f933d | 2154 |
| 1921009 | adalimumab 10 MG in 0.1 ML Prefilled Syringe | PSN | 608d4f0d-b19f-46d3-749a-7159aa5f933d | 2154 |
| 1921016 | adalimumab 20 MG in 0.2 ML Prefilled Syringe | PSN | 608d4f0d-b19f-46d3-749a-7159aa5f933d | 2154 |
| 763564 | adalimumab 20 MG in 0.4 ML Prefilled Syringe | PSN | 608d4f0d-b19f-46d3-749a-7159aa5f933d | 2154 |
| 1872979 | adalimumab 40 MG in 0.4 ML Auto-Injector | PSN | 608d4f0d-b19f-46d3-749a-7159aa5f933d | 2154 |
| 1726844 | adalimumab 40 MG in 0.4 ML Prefilled Syringe | PSN | 608d4f0d-b19f-46d3-749a-7159aa5f933d | 2154 |
| 1655726 | adalimumab 40 MG in 0.8 ML Auto-Injector | PSN | 608d4f0d-b19f-46d3-749a-7159aa5f933d | 2154 |
| 727703 | adalimumab 40 MG in 0.8 ML Prefilled Syringe | PSN | 608d4f0d-b19f-46d3-749a-7159aa5f933d | 2154 |
| 1921238 | adalimumab 80 MG in 0.8 mL Auto-Injector | PSN | 608d4f0d-b19f-46d3-749a-7159aa5f933d | 2154 |
| 1855523 | adalimumab 80 MG in 0.8 ML Prefilled Syringe | PSN | 608d4f0d-b19f-46d3-749a-7159aa5f933d | 2154 |
| 1594357 | adalimumab pediatric starter pack 40 MG/0.8 ML Prefilled Syringe (3 count) | PSN | 608d4f0d-b19f-46d3-749a-7159aa5f933d | 2154 |
| 825169 | adalimumab pediatric starter pack 40 MG/0.8 ML Prefilled Syringe (6 count) | PSN | 608d4f0d-b19f-46d3-749a-7159aa5f933d | 2154 |
| 1855526 | adalimumab pediatric starter pack 80 MG/0.8 ML and 40 MG/0.4 ML Prefilled Syringe (2 count) | PSN | 608d4f0d-b19f-46d3-749a-7159aa5f933d | 2154 |
| 1873086 | adalimumab pediatric starter pack 80 MG/0.8 ML Prefilled Syringe (3 count) | PSN | 608d4f0d-b19f-46d3-749a-7159aa5f933d | 2154 |
| 1872985 | adalimumab starter pack 40 MG/0.4 ML Pen (4 count) | PSN | 608d4f0d-b19f-46d3-749a-7159aa5f933d | 2154 |
| 1872983 | adalimumab starter pack 40 MG/0.4 ML Pen (6 count) | PSN | 608d4f0d-b19f-46d3-749a-7159aa5f933d | 2154 |
| 1801277 | adalimumab starter pack 40 MG/0.8 ML Pen (4 count) | PSN | 608d4f0d-b19f-46d3-749a-7159aa5f933d | 2154 |
| 1656703 | adalimumab starter pack 40 MG/0.8 ML Pen (6 count) | PSN | 608d4f0d-b19f-46d3-749a-7159aa5f933d | 2154 |
| 1921467 | adalimumab starter pack 80 MG/0.8 mL and 40 MG/0.4 mL Auto-Injector (3 count) | PSN | 608d4f0d-b19f-46d3-749a-7159aa5f933d | 2154 |
| 1921244 | adalimumab starter pack 80 MG/0.8 mL Auto-Injector (3 count) | PSN | 608d4f0d-b19f-46d3-749a-7159aa5f933d | 2154 |
| 2531133 | adalimumab starter pack 80 MG/0.8 ML Pen (4 count) | PSN | 608d4f0d-b19f-46d3-749a-7159aa5f933d | 2154 |
| 1921010 | Humira 10 MG in 0.1 ML Prefilled Syringe | PSN | 608d4f0d-b19f-46d3-749a-7159aa5f933d | 2154 |
| 1921017 | Humira 20 MG in 0.2 ML Prefilled Syringe | PSN | 608d4f0d-b19f-46d3-749a-7159aa5f933d | 2154 |
| 763565 | Humira 20 MG in 0.4 ML Prefilled Syringe | PSN | 608d4f0d-b19f-46d3-749a-7159aa5f933d | 2154 |
| 1872980 | Humira 40 MG in 0.4 ML Auto-Injector | PSN | 608d4f0d-b19f-46d3-749a-7159aa5f933d | 2154 |
| 1726846 | Humira 40 MG in 0.4 ML Prefilled Syringe | PSN | 608d4f0d-b19f-46d3-749a-7159aa5f933d | 2154 |
| 1655728 | Humira 40 MG in 0.8 ML Auto-Injector | PSN | 608d4f0d-b19f-46d3-749a-7159aa5f933d | 2154 |
| 727705 | Humira 40 MG in 0.8 ML Prefilled Syringe | PSN | 608d4f0d-b19f-46d3-749a-7159aa5f933d | 2154 |
| 1921240 | Humira 80 MG in 0.8 mL Auto-Injector | PSN | 608d4f0d-b19f-46d3-749a-7159aa5f933d | 2154 |
| 1855524 | Humira 80 MG in 0.8 ML Prefilled Syringe | PSN | 608d4f0d-b19f-46d3-749a-7159aa5f933d | 2154 |
| 1855527 | Humira Pediatric Crohn's Disease Starter Package (2 count) | PSN | 608d4f0d-b19f-46d3-749a-7159aa5f933d | 2154 |
| 1594358 | Humira Pediatric Crohn's Disease Starter Package (3 count) | PSN | 608d4f0d-b19f-46d3-749a-7159aa5f933d | 2154 |
| 1594352 | Humira Pediatric Crohn's Disease Starter Package (6 count) | PSN | 608d4f0d-b19f-46d3-749a-7159aa5f933d | 2154 |
| 1872984 | Humira Pen 40 MG/0.4 ML Starter Pack - Crohn's Disease, Ulcerative Colitis or Hidradenitis Suppurativa (6 count) | PSN | 608d4f0d-b19f-46d3-749a-7159aa5f933d | 2154 |
| 1872986 | Humira Pen 40 MG/0.4 ML Starter Pack - Psoriasis/Uveitis (4 count) | PSN | 608d4f0d-b19f-46d3-749a-7159aa5f933d | 2154 |
| 825170 | Humira Pen 40 MG/0.8 ML - Crohn's Disease/Ulcerative Colitis Starter Pack | PSN | 608d4f0d-b19f-46d3-749a-7159aa5f933d | 2154 |
| 1921245 | Humira Pen 80 MG/0.8 ML - Starter Package for Crohn's Disease, Ulcerative Colitis or Hidradenitis Suppurativa (3 count) | PSN | 608d4f0d-b19f-46d3-749a-7159aa5f933d | 2154 |
| 2531134 | Humira Pen 80 MG/0.8 ML - Starter Package for Pediatric Ulcerative Colitis (4 count) | PSN | 608d4f0d-b19f-46d3-749a-7159aa5f933d | 2154 |
| 1921468 | Humira Pen 80 MG/0.8 ML and 40 MG/0.4 ML - Psoriasis/Uveitis Starter Package (3 count) | PSN | 608d4f0d-b19f-46d3-749a-7159aa5f933d | 2154 |
| 1873087 | Humira Prefilled Syringe 80 MG/0.8 ML Starter Pack - Pediatric Crohn's Disease (3 count) | PSN | 608d4f0d-b19f-46d3-749a-7159aa5f933d | 2154 |
| 1801278 | Humira Psoriasis/Uveitis Starter Pack 40 MG/0.8 ML Pen (4 count) | PSN | 608d4f0d-b19f-46d3-749a-7159aa5f933d | 2154 |
| 797544 | isopropyl alcohol 70 % Medicated Pad | PSN | 608d4f0d-b19f-46d3-749a-7159aa5f933d | 2154 |
| 1921010 | 0.1 ML adalimumab 100 MG/ML Prefilled Syringe [Humira] | SBD | 608d4f0d-b19f-46d3-749a-7159aa5f933d | 2154 |
| 1921017 | 0.2 ML adalimumab 100 MG/ML Prefilled Syringe [Humira] | SBD | 608d4f0d-b19f-46d3-749a-7159aa5f933d | 2154 |
| 1872980 | 0.4 ML adalimumab 100 MG/ML Auto-Injector [Humira] | SBD | 608d4f0d-b19f-46d3-749a-7159aa5f933d | 2154 |
| 1726846 | 0.4 ML adalimumab 100 MG/ML Prefilled Syringe [Humira] | SBD | 608d4f0d-b19f-46d3-749a-7159aa5f933d | 2154 |
| 763565 | 0.4 ML adalimumab 50 MG/ML Prefilled Syringe [Humira] | SBD | 608d4f0d-b19f-46d3-749a-7159aa5f933d | 2154 |
| 1921240 | 0.8 ML adalimumab 100 MG/ML Auto-Injector [Humira] | SBD | 608d4f0d-b19f-46d3-749a-7159aa5f933d | 2154 |
| 1855524 | 0.8 ML adalimumab 100 MG/ML Prefilled Syringe [Humira] | SBD | 608d4f0d-b19f-46d3-749a-7159aa5f933d | 2154 |
| 1655728 | 0.8 ML adalimumab 50 MG/ML Auto-Injector [Humira] | SBD | 608d4f0d-b19f-46d3-749a-7159aa5f933d | 2154 |
| 727705 | 0.8 ML adalimumab 50 MG/ML Prefilled Syringe [Humira] | SBD | 608d4f0d-b19f-46d3-749a-7159aa5f933d | 2154 |
| 1921009 | 0.1 ML adalimumab 100 MG/ML Prefilled Syringe | SCD | 608d4f0d-b19f-46d3-749a-7159aa5f933d | 2154 |
| 1921016 | 0.2 ML adalimumab 100 MG/ML Prefilled Syringe | SCD | 608d4f0d-b19f-46d3-749a-7159aa5f933d | 2154 |
| 1872979 | 0.4 ML adalimumab 100 MG/ML Auto-Injector | SCD | 608d4f0d-b19f-46d3-749a-7159aa5f933d | 2154 |
| 1726844 | 0.4 ML adalimumab 100 MG/ML Prefilled Syringe | SCD | 608d4f0d-b19f-46d3-749a-7159aa5f933d | 2154 |
| 763564 | 0.4 ML adalimumab 50 MG/ML Prefilled Syringe | SCD | 608d4f0d-b19f-46d3-749a-7159aa5f933d | 2154 |
| 1921238 | 0.8 ML adalimumab 100 MG/ML Auto-Injector | SCD | 608d4f0d-b19f-46d3-749a-7159aa5f933d | 2154 |
| 1855523 | 0.8 ML adalimumab 100 MG/ML Prefilled Syringe | SCD | 608d4f0d-b19f-46d3-749a-7159aa5f933d | 2154 |
| 1655726 | 0.8 ML adalimumab 50 MG/ML Auto-Injector | SCD | 608d4f0d-b19f-46d3-749a-7159aa5f933d | 2154 |