DIMETHYL FUMARATE

Product NDC: 43547-024
11-digit product format: 435470024
Labeler code: 43547
Product ID: 43547-024_870120b7-7d68-4e5f-98cc-ac646624feb4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: dimethyl fumarate
Dosage form: CAPSULE, DELAYED RELEASE
Route: ORAL
Labeler: Solco Healthcare US, LLC
Application: ANDA210414
Marketing category: ANDA
Marketing start: 2022-10-18
Substance: DIMETHYL FUMARATE
Active strength: 120 mg/1
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A210414-001	DIMETHYL FUMARATE	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB		2022-10-18
A210414-002	DIMETHYL FUMARATE	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB		2022-10-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210414-001	AB
A210414-002	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
2026-08-18 06:07:40	2026-07	A210414-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-10-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210414-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-10-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210414-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-10-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210414-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-10-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210414-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-10-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210414-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-10-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210414-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-10-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210414-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-10-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210414-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-10-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210414-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-10-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210414-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-10-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210414-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-10-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210414-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-10-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210414-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-10-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210414-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-10-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210414-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-10-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210414-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-10-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210414-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-10-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210414-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-10-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210414-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-10-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210414-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-10-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210414-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-10-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210414-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-10-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210414-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-10-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210414-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-10-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210414-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-10-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210414-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-10-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210414-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-10-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210414-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-10-18	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210414-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-10-18	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210414-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-10-18	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210414-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-10-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210414-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-10-18	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A210414-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-10-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210414-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-10-18	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A210414-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-10-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210414-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-10-18	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210414-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-10-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210414-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-10-18	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210414-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-10-18	`9b2671bbb829…`

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
2026-08-18 06:07:40	2026-07	A210414-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210414-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210414-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210414-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210414-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210414-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210414-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210414-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210414-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210414-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210414-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210414-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210414-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210414-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210414-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210414-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210414-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210414-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210414-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210414-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210414-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210414-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210414-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210414-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210414-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210414-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210414-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210414-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210414-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210414-002	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210414-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210414-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210414-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A210414-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210414-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A210414-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210414-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210414-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210414-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210414-002	AB	1	`9b2671bbb829…`

Additional Listing Data#

Finished product: Yes
Brand name base: DIMETHYL FUMARATE
Listing expiration: 2026-12-31

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
a3677dce-a44b-481f-8a76-9ff3a4d42105	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
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 table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
43547-024-14	DIMETHYL FUMARATE	14 in 1 BOTTLE, PLASTIC	CAPSULE, DELAYED RELEASE	14		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43547-024-14	EA - Each	43547-024	32326e02-645e-4ed7-97ab-2cf7b8b823f7	1	2023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43547-024	DIMETHYL FUMARATE CAPSULE, DELAYED RELEASE [SOLCO HEALTHCARE US, LLC]	5	Current NDC, Legacy NDC, 1 package rows	20240927_a3677dce-a44b-481f-8a76-9ff3a4d42105.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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DIMETHYL FUMARATE	DIMETHYL FUMARATE	Solco Healthcare US, LLC	a3677dce-a44b-481f-8a76-9ff3a4d42105	2024-06-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210414 application number: ANDA210414 ndc (product): 43547-024

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1373483	dimethyl fumarate 120 MG Delayed Release Oral Capsule	PSN	a3677dce-a44b-481f-8a76-9ff3a4d42105	5
1373491	dimethyl fumarate 240 MG Delayed Release Oral Capsule	PSN	a3677dce-a44b-481f-8a76-9ff3a4d42105	5
1373483	dimethyl fumarate 120 MG Delayed Release Oral Capsule	SCD	a3677dce-a44b-481f-8a76-9ff3a4d42105	5
1373491	dimethyl fumarate 240 MG Delayed Release Oral Capsule	SCD	a3677dce-a44b-481f-8a76-9ff3a4d42105	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
43547-024-14	43547002414	14 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (43547-024-14)	2022-10-18	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DIMETHYL FUMARATE	Solco Healthcare US, LLC \| Prinston Pharmaceutical Inc.	2024-06-27	HUMAN PRESCRIPTION DRUG LABEL	5