Dimethyl Fumarate

Product NDC: 84677-029
11-digit product format: 846770029
Labeler code: 84677
Product ID: 84677-029_5361d4c3-ed4f-9afd-e063-6294a90a42ec
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dimethyl Fumarate
Dosage form: CAPSULE, DELAYED RELEASE
Route: ORAL
Labeler: Golden State Medical Supply, Inc.
Application: ANDA210385
Marketing category: ANDA
Marketing start: 2022-12-22
Substance: DIMETHYL FUMARATE
Active strength: 120 mg/1
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A210385-001	DIMETHYL FUMARATE	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB		2022-12-22
A210385-002	DIMETHYL FUMARATE	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB		2022-12-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A210385-001	AB
A210385-002	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.

Product history page 1 of 2 · 52 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A210385-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-12-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210385-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-12-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210385-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-12-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210385-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-12-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210385-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-12-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210385-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-12-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210385-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-12-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210385-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-12-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210385-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-12-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210385-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-12-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210385-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-12-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210385-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-12-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210385-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-12-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210385-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-12-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210385-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-12-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210385-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-12-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210385-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-12-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210385-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-12-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210385-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-12-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210385-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-12-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210385-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-12-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210385-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-12-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210385-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-12-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210385-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-12-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210385-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-12-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210385-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-12-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210385-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-12-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210385-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-12-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210385-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-12-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210385-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-12-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210385-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-12-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210385-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-12-22	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210385-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-12-22	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210385-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-12-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210385-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-12-22	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A210385-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-12-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210385-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-12-22	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A210385-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-12-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210385-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-12-22	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210385-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-12-22	`a72a2bbeb626…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 52 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A210385-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210385-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210385-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210385-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210385-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210385-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210385-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210385-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210385-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210385-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210385-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210385-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210385-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210385-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210385-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210385-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210385-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210385-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210385-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210385-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210385-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210385-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210385-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210385-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210385-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210385-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210385-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210385-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210385-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210385-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210385-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210385-002	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210385-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210385-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210385-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A210385-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210385-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A210385-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210385-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210385-002	AB	1	`a72a2bbeb626…`

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: Dimethyl Fumarate
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DIMETHYL FUMARATE	120 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
FO2303MNI2	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1373483	Internal RxNorm lookup
1373491	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
5361d5c6-c3eb-88e6-e063-6294a90ac08c	Available on FDA.report

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dimethyl Fumarate	DIMETHYL FUMARATE	Golden State Medical Supply, Inc.	5361d5c6-c3eb-88e6-e063-6294a90ac08c	2026-06-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210385 application number: ANDA210385 ndc (product): 84677-029
Dimethyl Fumarate	DIMETHYL FUMARATE	Aurobindo Pharma Limited	08f3a987-6571-42b3-854b-186d782b4494	2024-04-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210385 application number: ANDA210385

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
FO2303MNI2	DIMETHYL FUMARATE	624-49-7	DIMETHYL FUMARATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
84677-029-14	84677002914	14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (84677-029-14)	2026-05-12	No	No	Current