DIMETHYL FUMARATE

Product NDC: 82009-138
11-digit product format: 820090138
Labeler code: 82009
Product ID: 82009-138_425dfa4b-ae5d-578b-e063-6394a90a4d3b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: DIMETHYL FUMARATE
Dosage form: CAPSULE, DELAYED RELEASE
Route: ORAL
Labeler: Quallent Pharmaceuticals Health LLC
Application: ANDA210500
Marketing category: ANDA
Marketing start: 2024-06-15
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
A210500-001	DIMETHYL FUMARATE	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB		2020-09-24
A210500-002	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
A210500-001	AB
A210500-002	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	A210500-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-09-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210500-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-09-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210500-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-09-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210500-002	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	A210500-001	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	A210500-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-09-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210500-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-09-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210500-002	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	A210500-001	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	A210500-002	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	A210500-001	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	A210500-002	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	A210500-001	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	A210500-002	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	A210500-001	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	A210500-002	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	A210500-001	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	A210500-002	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	A210500-001	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	A210500-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-09-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210500-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-09-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210500-002	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	A210500-001	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	A210500-002	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	A210500-001	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	A210500-002	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	A210500-001	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	A210500-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-09-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210500-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-09-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210500-002	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	A210500-001	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	A210500-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-09-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210500-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-09-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210500-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-09-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210500-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-09-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210500-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-09-24	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A210500-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-09-24	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210500-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-09-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210500-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-09-24	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A210500-002	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	A210500-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210500-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210500-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210500-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210500-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210500-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210500-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210500-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210500-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210500-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210500-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210500-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210500-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210500-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210500-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210500-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210500-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210500-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210500-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210500-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210500-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210500-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210500-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210500-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210500-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210500-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210500-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210500-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210500-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210500-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210500-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210500-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210500-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210500-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210500-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210500-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A210500-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210500-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210500-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A210500-002	AB	1	`782e0a99824c…`

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	A210500-001	PC	2021-02-14	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A210500-002	PC	2021-02-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210500-001	PC	2021-02-14	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210500-002	PC	2021-02-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210500-001	PC	2021-02-14	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A210500-002	PC	2021-02-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210500-001	PC	2021-02-14	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A210500-002	PC	2021-02-14	`8869cabd3fbd…`

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
39150ef0-ba48-4719-b7fd-9beb4d4ad3ce	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
fb7ab793-2c12-4079-b100-a64f73bef25a	Product name	4	20240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7	Product name	2	20230717
dc7c5daa-021f-40dd-b00d-63982cb2067a	Product name	1	20230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
81073386-7d67-4d1d-80dd-72b360506a77	Product name	1	20200414
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
82009-138-60	DIMETHYL FUMARATE	1 in 1 CARTON	CAPSULE, DELAYED RELEASE	1		2
82009-138-60	DIMETHYL FUMARATE	60 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	60		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
82009-138-60	EA - Each	82009-138	a5302732-bea2-4f9e-b215-56535dc169d8	1	2024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
82009-138	DIMETHYL FUMARATE (DIMETHYL FUMARATE) CAPSULE, DELAYED RELEASE [QUALLENT PHARMACEUTICALS HEALTH LLC]	1	Current NDC, 2 package rows	20240616_39150ef0-ba48-4719-b7fd-9beb4d4ad3ce.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DIMETHYL FUMARATE	DIMETHYL FUMARATE	A-S Medication Solutions	c2b19329-5c1d-4879-85a9-36ffec3ff5cb	2026-01-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210500 application number: ANDA210500
DIMETHYL FUMARATE	DIMETHYL FUMARATE	Quallent Pharmaceuticals Health LLC	39150ef0-ba48-4719-b7fd-9beb4d4ad3ce	2025-10-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210500 application number: ANDA210500 ndc (product): 82009-138
DIMETHYL FUMARATE	DIMETHYL FUMARATE	Camber Pharmaceuticals, Inc.	b856ac70-71cd-477b-95b1-0a6132c260e8	2024-05-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210500 application number: ANDA210500

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
1373491	dimethyl fumarate 240 MG Delayed Release Oral Capsule	PSN	39150ef0-ba48-4719-b7fd-9beb4d4ad3ce	2
1373491	dimethyl fumarate 240 MG Delayed Release Oral Capsule	SCD	39150ef0-ba48-4719-b7fd-9beb4d4ad3ce	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
82009-138-60	82009013860	1 BOTTLE in 1 CARTON (82009-138-60) / 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE	1 bottle	2024-06-15	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DIMETHYL FUMARATE	Quallent Pharmaceuticals Health LLC \| Hetero Labs Limited Unit III	2025-10-30	HUMAN PRESCRIPTION DRUG LABEL	2