DIMETHYL FUMARATE

Product NDC: 16729-417
11-digit product format: 167290417
Labeler code: 16729
Product ID: 16729-417_460073d9-4e0e-e90b-e063-6394a90a4ebc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dimethyl fumarate
Dosage form: CAPSULE, DELAYED RELEASE
Route: ORAL
Labeler: Accord Healthcare Inc.
Application: ANDA210499
Marketing category: ANDA
Marketing start: 2021-01-13
Substance: DIMETHYL FUMARATE
Active strength: 240 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
A210499-001	DIMETHYL FUMARATE	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB		2020-09-24
A210499-002	DIMETHYL FUMARATE	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB		2020-09-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210499-001	AB
A210499-002	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 · 76 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	A210499-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-09-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210499-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-09-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210499-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-09-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210499-002	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	A210499-001	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	A210499-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-09-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210499-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-09-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210499-002	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	A210499-001	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	A210499-002	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	A210499-001	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	A210499-002	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	A210499-001	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	A210499-002	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	A210499-001	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	A210499-002	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	A210499-001	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	A210499-002	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	A210499-001	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	A210499-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-09-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210499-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-09-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210499-002	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	A210499-001	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	A210499-002	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	A210499-001	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	A210499-002	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	A210499-001	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	A210499-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-09-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210499-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-09-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210499-002	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	A210499-001	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	A210499-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-09-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210499-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-09-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210499-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-09-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210499-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-09-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210499-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-09-24	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A210499-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-09-24	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210499-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-09-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210499-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-09-24	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A210499-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-09-24	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 76 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	A210499-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210499-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210499-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210499-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210499-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210499-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210499-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210499-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210499-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210499-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210499-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210499-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210499-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210499-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210499-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210499-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210499-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210499-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210499-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210499-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210499-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210499-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210499-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210499-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210499-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210499-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210499-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210499-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210499-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210499-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210499-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210499-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210499-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210499-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210499-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210499-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A210499-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210499-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210499-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A210499-002	AB	1	`782e0a99824c…`

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	240 mg/1

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
16729-417-12	DIMETHYL FUMARATE	60 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	60		8
16729-417-16	DIMETHYL FUMARATE	500 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	500		8
16729-417-27	DIMETHYL FUMARATE	46 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	46		8
16729-417-46	DIMETHYL FUMARATE	46 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	46	240 mg	8
16729-417-59	DIMETHYL FUMARATE	180 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	180		8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16729-417	DIMETHYL FUMARATE KIT DIMETHYL FUMARATE CAPSULE, DELAYED RELEASE [ACCORD HEALTHCARE INC.]	8	Current NDC, Legacy NDC, 4 package rows	20230901_c4003a54-f880-4d06-9b5a-f8043791937b.zip

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
1373497	{14 (dimethyl fumarate 120 MG Delayed Release Oral Capsule) / 46 (dimethyl fumarate 240 MG Delayed Release Oral Capsule) } Pack	GPCK	c4003a54-f880-4d06-9b5a-f8043791937b	8
1373483	dimethyl fumarate 120 MG Delayed Release Oral Capsule	PSN	c4003a54-f880-4d06-9b5a-f8043791937b	8
1373491	dimethyl fumarate 240 MG Delayed Release Oral Capsule	PSN	c4003a54-f880-4d06-9b5a-f8043791937b	8
1373497	dimethyl fumarate starter dose 120 MG (14), 240 MG (46) Delayed Release Oral Capsule 60 Count Pack	PSN	c4003a54-f880-4d06-9b5a-f8043791937b	8
1373483	dimethyl fumarate 120 MG Delayed Release Oral Capsule	SCD	c4003a54-f880-4d06-9b5a-f8043791937b	8
1373491	dimethyl fumarate 240 MG Delayed Release Oral Capsule	SCD	c4003a54-f880-4d06-9b5a-f8043791937b	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
16729-417-12	16729041712	60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (16729-417-12)	2021-01-13	0000-00-00	No	No	Current
16729-417-16	16729041716	500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (16729-417-16)	2022-09-26	0000-00-00	No	No	Current
16729-417-27	16729041727	46 CAPSULE, DELAYED RELEASE in 1 BOTTLE (16729-417-27)	2022-09-26	0000-00-00	No	No	Current
16729-417-46	16729041746	46 in 1 BOTTLE					Historical
16729-417-59	16729041759	180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (16729-417-59)	2021-01-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DIMETHYL FUMARATE	Accord Healthcare Inc. \| Intas Pharmaceuticals Limited	2023-08-31	HUMAN PRESCRIPTION DRUG LABEL	8