Dimethyl Fumarate

Product NDC: 69539-240
11-digit product format: 695390240
Labeler code: 69539
Product ID: 69539-240_1e7672d0-2532-401b-81a2-dd76968d2745
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dimethyl Fumarate
Dosage form: KIT
Labeler: MSN LABORATORIES PRIVATE LIMITED
Application: ANDA210460
Marketing category: ANDA
Marketing start: 2021-05-20
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 1.

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
A210460-001	DIMETHYL FUMARATE	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB		2020-09-24
A210460-002	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
A210460-001	AB
A210460-002	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 · 74 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
2026-02-19 14:30 UTC	2026-02	A210460-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-09-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210460-002	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	A210460-001	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	A210460-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-09-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210460-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-09-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210460-002	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	A210460-001	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	A210460-002	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	A210460-001	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	A210460-002	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	A210460-001	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	A210460-002	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	A210460-001	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	A210460-002	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	A210460-001	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	A210460-002	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	A210460-001	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	A210460-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-09-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210460-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-09-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210460-002	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	A210460-001	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	A210460-002	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	A210460-001	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	A210460-002	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	A210460-001	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	A210460-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-09-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210460-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-09-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210460-002	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	A210460-001	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	A210460-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-09-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210460-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-09-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210460-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-09-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210460-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-09-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210460-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-09-24	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A210460-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-09-24	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210460-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-09-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210460-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-09-24	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A210460-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-09-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210460-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-09-24	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210460-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-09-24	`87673890dc5c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 74 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A210460-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210460-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210460-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210460-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210460-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210460-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210460-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210460-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210460-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210460-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210460-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210460-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210460-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210460-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210460-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210460-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210460-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210460-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210460-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210460-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210460-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210460-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210460-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210460-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210460-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210460-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210460-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210460-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210460-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210460-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210460-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210460-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210460-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210460-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A210460-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210460-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210460-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A210460-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210460-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210460-002	AB	1	`87673890dc5c…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2021-12-28 21:50 UTC	2021-12	A210460-001	PC	2021-02-14	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A210460-002	PC	2021-02-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210460-001	PC	2021-02-14	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210460-002	PC	2021-02-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210460-001	PC	2021-02-14	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A210460-002	PC	2021-02-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210460-001	PC	2021-02-14	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A210460-002	PC	2021-02-14	`8869cabd3fbd…`

Additional Listing Data#

Finished product: Yes
Brand name base: Dimethyl Fumarate
Listing expiration: 2026-12-31

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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1373483	Internal RxNorm lookup
1373491	Internal RxNorm lookup
1373497	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
074d2820-6cb4-437a-8f6f-a21cb0a8ee02	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
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
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
69539-240-18	Dimethyl Fumarate	1 in 1 KIT	KIT	1		6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69539-240	DIMETHYL FUMARATE CAPSULE, DELAYED RELEASE DIMETHYL FUMARATE KIT [MSN LABORATORIES PRIVATE LIMITED]	6	Current NDC, Legacy NDC, 1 package rows	20210714_074d2820-6cb4-437a-8f6f-a21cb0a8ee02.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dimethyl Fumarate	DIMETHYL FUMARATE	Dr. Reddy's Laboratories Inc.	b00dcf89-59d3-9ab2-fd9b-16b9ec2d677b	2025-10-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210460 application number: ANDA210460
Dimethyl Fumarate	DIMETHYL FUMARATE	MSN LABORATORIES PRIVATE LIMITED	074d2820-6cb4-437a-8f6f-a21cb0a8ee02	2021-07-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210460 application number: ANDA210460 ndc (product): 69539-240

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	074d2820-6cb4-437a-8f6f-a21cb0a8ee02	6
1373483	dimethyl fumarate 120 MG Delayed Release Oral Capsule	PSN	074d2820-6cb4-437a-8f6f-a21cb0a8ee02	6
1373491	dimethyl fumarate 240 MG Delayed Release Oral Capsule	PSN	074d2820-6cb4-437a-8f6f-a21cb0a8ee02	6
1373497	dimethyl fumarate starter dose 120 MG (14), 240 MG (46) Delayed Release Oral Capsule 60 Count Pack	PSN	074d2820-6cb4-437a-8f6f-a21cb0a8ee02	6
1373483	dimethyl fumarate 120 MG Delayed Release Oral Capsule	SCD	074d2820-6cb4-437a-8f6f-a21cb0a8ee02	6
1373491	dimethyl fumarate 240 MG Delayed Release Oral Capsule	SCD	074d2820-6cb4-437a-8f6f-a21cb0a8ee02	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69539-240-18	69539024018	1 KIT in 1 KIT (69539-240-18) * 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE * 46 CAPSULE, DELAYED RELEASE in 1 BOTTLE	1 kit	2021-05-20	0000-00-00	No	No	Current