Dimethyl Fumarate
- Product NDC
- 67877-557
- 11-digit product format
- 678770557
- Labeler code
- 67877
- Product ID
- 67877-557_75f80267-a5b2-4117-8003-05da3e461217
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dimethyl Fumarate
- Dosage form
- KIT
- Labeler
- Ascend Laboratories, LLC
- Application
- ANDA210440
- Marketing category
- ANDA
- Marketing start
- 2020-09-26
- 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 |
|---|---|---|---|---|---|---|---|
| A210440-001 | DIMETHYL FUMARATE | DIMETHYL FUMARATE | 120MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2020-09-24 | |
| A210440-002 | DIMETHYL FUMARATE | DIMETHYL FUMARATE | 240MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2020-09-24 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A210440-001 | AB |
| A210440-002 | AB |
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 | A210440-001 | DIMETHYL FUMARATE | 120MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2020-09-24 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A210440-002 | DIMETHYL FUMARATE | 240MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2020-09-24 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A210440-001 | DIMETHYL FUMARATE | 120MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2020-09-24 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A210440-002 | DIMETHYL FUMARATE | 240MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2020-09-24 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210440-001 | DIMETHYL FUMARATE | 120MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2020-09-24 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210440-002 | DIMETHYL FUMARATE | 240MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2020-09-24 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A210440-001 | DIMETHYL FUMARATE | 120MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2020-09-24 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A210440-002 | DIMETHYL FUMARATE | 240MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2020-09-24 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210440-001 | DIMETHYL FUMARATE | 120MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2020-09-24 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210440-002 | DIMETHYL FUMARATE | 240MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2020-09-24 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210440-001 | DIMETHYL FUMARATE | 120MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2020-09-24 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210440-002 | DIMETHYL FUMARATE | 240MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2020-09-24 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210440-001 | DIMETHYL FUMARATE | 120MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2020-09-24 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210440-002 | DIMETHYL FUMARATE | 240MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2020-09-24 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210440-001 | DIMETHYL FUMARATE | 120MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2020-09-24 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210440-002 | DIMETHYL FUMARATE | 240MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2020-09-24 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210440-001 | DIMETHYL FUMARATE | 120MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2020-09-24 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210440-002 | DIMETHYL FUMARATE | 240MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2020-09-24 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210440-001 | DIMETHYL FUMARATE | 120MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2020-09-24 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210440-002 | DIMETHYL FUMARATE | 240MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2020-09-24 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A210440-001 | DIMETHYL FUMARATE | 120MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2020-09-24 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A210440-002 | DIMETHYL FUMARATE | 240MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2020-09-24 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210440-001 | DIMETHYL FUMARATE | 120MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2020-09-24 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210440-002 | DIMETHYL FUMARATE | 240MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2020-09-24 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210440-001 | DIMETHYL FUMARATE | 120MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2020-09-24 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210440-002 | DIMETHYL FUMARATE | 240MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2020-09-24 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A210440-001 | DIMETHYL FUMARATE | 120MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2020-09-24 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A210440-002 | DIMETHYL FUMARATE | 240MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2020-09-24 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A210440-001 | DIMETHYL FUMARATE | 120MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2020-09-24 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A210440-002 | DIMETHYL FUMARATE | 240MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2020-09-24 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A210440-001 | DIMETHYL FUMARATE | 120MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2020-09-24 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A210440-002 | DIMETHYL FUMARATE | 240MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2020-09-24 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A210440-001 | DIMETHYL FUMARATE | 120MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2020-09-24 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A210440-002 | DIMETHYL FUMARATE | 240MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2020-09-24 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A210440-001 | DIMETHYL FUMARATE | 120MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2020-09-24 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A210440-002 | DIMETHYL FUMARATE | 240MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2020-09-24 | 4b0b4de00fa7… | |
| 2022-03-09 01:35 UTC | 2022-03 | A210440-001 | DIMETHYL FUMARATE | 120MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2020-09-24 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A210440-002 | DIMETHYL FUMARATE | 240MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2020-09-24 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A210440-001 | DIMETHYL FUMARATE | 120MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2020-09-24 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | A210440-002 | DIMETHYL FUMARATE | 240MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2020-09-24 | 782e0a99824c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A210440-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A210440-002 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A210440-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A210440-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210440-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210440-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A210440-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A210440-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210440-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210440-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210440-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210440-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210440-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210440-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210440-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210440-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210440-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210440-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210440-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210440-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A210440-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A210440-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210440-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210440-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210440-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210440-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A210440-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A210440-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A210440-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A210440-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A210440-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A210440-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A210440-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A210440-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A210440-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A210440-002 | AB | 1 | 4b0b4de00fa7… |
| 2022-03-09 01:35 UTC | 2022-03 | A210440-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A210440-002 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A210440-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A210440-002 | AB | 1 | 782e0a99824c… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Dimethyl Fumarate
- Listing expiration
- 2026-12-31
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| FO2303MNI2 | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| e12d8fee-bd18-4f84-8333-c890f1d132b7 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 782c9b32-f61c-48d7-9845-328403da8b33 | Product name | 5 | 20250303 |
| 81073386-7d67-4d1d-80dd-72b360506a77 | Product name | 1 | 20200414 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 67877-557-39 | Dimethyl Fumarate | 1 in 1 KIT | KIT | 1 | 16 |
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 |
|---|---|---|---|---|---|---|
| Dimethyl fumarate | DIMETHYL FUMARATE | Ascend Laboratories, LLC | e12d8fee-bd18-4f84-8333-c890f1d132b7 | 2025-09-26 | Warnings, Adverse reactions | 210440 ANDA210440 67877-557 |
| Dimethyl fumarate | DIMETHYL FUMARATE | CivicaScript LLC | f3002b6a-841e-4247-9155-3acfb30cabcd | 2025-06-10 | Warnings, Adverse reactions | 210440 ANDA210440 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1373497 | {14 (dimethyl fumarate 120 MG Delayed Release Oral Capsule) / 46 (dimethyl fumarate 240 MG Delayed Release Oral Capsule) } Pack | GPCK | e12d8fee-bd18-4f84-8333-c890f1d132b7 | 16 |
| 1373483 | dimethyl fumarate 120 MG Delayed Release Oral Capsule | PSN | e12d8fee-bd18-4f84-8333-c890f1d132b7 | 16 |
| 1373491 | dimethyl fumarate 240 MG Delayed Release Oral Capsule | PSN | e12d8fee-bd18-4f84-8333-c890f1d132b7 | 16 |
| 1373497 | dimethyl fumarate starter dose 120 MG (14), 240 MG (46) Delayed Release Oral Capsule 60 Count Pack | PSN | e12d8fee-bd18-4f84-8333-c890f1d132b7 | 16 |
| 1373483 | dimethyl fumarate 120 MG Delayed Release Oral Capsule | SCD | e12d8fee-bd18-4f84-8333-c890f1d132b7 | 16 |
| 1373491 | dimethyl fumarate 240 MG Delayed Release Oral Capsule | SCD | e12d8fee-bd18-4f84-8333-c890f1d132b7 | 16 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 67877-557-39 | 67877055739 | 1 KIT in 1 KIT (67877-557-39) * 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC * 46 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC | 1 kit | 2020-09-26 | 0000-00-00 | No | No | Current |