DIMETHYL FUMARATE

Product NDC: 68462-308
11-digit product format: 684620308
Labeler code: 68462
Product ID: 68462-308_74611591-657b-40e8-8ae1-1e5533a05d97
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: dimethyl-fumarate
Dosage form: CAPSULE
Route: ORAL
Labeler: Glenmark Pharmaceuticals Inc., USA
Application: ANDA210309
Marketing category: ANDA
Marketing start: 2020-10-06
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
A210309-001	DIMETHYL FUMARATE	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB		2020-10-06
A210309-002	DIMETHYL FUMARATE	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB		2020-10-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210309-001	AB
A210309-002	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	A210309-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-10-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210309-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-10-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210309-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-10-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210309-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-10-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210309-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-10-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210309-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-10-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210309-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-10-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210309-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-10-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210309-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-10-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210309-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-10-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210309-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-10-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210309-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-10-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210309-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-10-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210309-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-10-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210309-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-10-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210309-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-10-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210309-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-10-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210309-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-10-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210309-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-10-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210309-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-10-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210309-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-10-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210309-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-10-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210309-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-10-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210309-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-10-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210309-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-10-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210309-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-10-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210309-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-10-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210309-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-10-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210309-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-10-06	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210309-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-10-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210309-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-10-06	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210309-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-10-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210309-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-10-06	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210309-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-10-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210309-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-10-06	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210309-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-10-06	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A210309-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-10-06	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210309-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-10-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210309-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-10-06	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A210309-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-10-06	`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	A210309-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210309-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210309-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210309-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210309-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210309-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210309-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210309-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210309-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210309-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210309-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210309-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210309-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210309-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210309-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210309-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210309-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210309-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210309-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210309-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210309-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210309-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210309-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210309-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210309-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210309-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210309-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210309-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210309-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210309-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210309-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210309-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210309-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210309-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210309-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210309-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A210309-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210309-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210309-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A210309-002	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

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
c3f65da9-f5f4-4161-aded-c23b16fd49ed	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	SPL version
68462-308-05	DIMETHYL FUMARATE	500 in 1 BOTTLE	CAPSULE	500	7
68462-308-60	DIMETHYL FUMARATE	60 in 1 BOTTLE	CAPSULE	60	7
68462-308-68	DIMETHYL FUMARATE	46 in 1 BOTTLE	CAPSULE	46	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68462-308	DIMETHYL FUMARATE (DIMETHYL FUMARATE KIT) KIT DIMETHYL FUMARATE (DIMETHYL-FUMARATE) CAPSULE [GLENMARK PHARMACEUTICALS INC., USA]	7	Current NDC, Legacy NDC, 3 package rows	20240427_c3f65da9-f5f4-4161-aded-c23b16fd49ed.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	Glenmark Pharmaceuticals Inc., USA	c3f65da9-f5f4-4161-aded-c23b16fd49ed	2024-04-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210309 application number: ANDA210309 ndc (product): 68462-308

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	c3f65da9-f5f4-4161-aded-c23b16fd49ed	7
1373483	dimethyl fumarate 120 MG Delayed Release Oral Capsule	PSN	c3f65da9-f5f4-4161-aded-c23b16fd49ed	7
1373491	dimethyl fumarate 240 MG Delayed Release Oral Capsule	PSN	c3f65da9-f5f4-4161-aded-c23b16fd49ed	7
1373497	dimethyl fumarate starter dose 120 MG (14), 240 MG (46) Delayed Release Oral Capsule 60 Count Pack	PSN	c3f65da9-f5f4-4161-aded-c23b16fd49ed	7
1373483	dimethyl fumarate 120 MG Delayed Release Oral Capsule	SCD	c3f65da9-f5f4-4161-aded-c23b16fd49ed	7
1373491	dimethyl fumarate 240 MG Delayed Release Oral Capsule	SCD	c3f65da9-f5f4-4161-aded-c23b16fd49ed	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68462-308-05	68462030805	500 CAPSULE in 1 BOTTLE (68462-308-05)	500 capsule	2020-10-06	0000-00-00	No	No	Current
68462-308-60	68462030860	60 CAPSULE in 1 BOTTLE (68462-308-60)	60 capsule	2020-10-06	0000-00-00	No	No	Current
68462-308-68	68462030868	46 CAPSULE in 1 BOTTLE (68462-308-68)	46 capsule	2020-10-06	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DIMETHYL FUMARATE	Glenmark Pharmaceuticals Inc., USA \| Glenmark Pharmaceuticals Limited	2024-04-23	HUMAN PRESCRIPTION DRUG LABEL	7