dimethyl fumarate

Product NDC: 70710-1416
11-digit product format: 707101416
Labeler code: 70710
Product ID: 70710-1416_906e7060-d5f6-408b-97c7-f598361c5840
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: dimethyl fumarate
Dosage form: KIT
Labeler: Zydus Pharmaceuticals USA Inc.
Application: ANDA210538
Marketing category: ANDA
Marketing start: 2020-09-28
Marketing end: 0000-00-00
Active strength: 0
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	70710-1416		D	Discontinued by firm		2026-08-17
excluded package	package	70710-1416	70710-1416-3	D	Discontinued by firm		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70710-1416-3	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70710-1416-3	`f5e01cc5f278…`	`a2eaf40c39c3…`

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
A210538-001	DIMETHYL FUMARATE	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL			2020-09-24
A210538-002	DIMETHYL FUMARATE	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL			2020-09-24

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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A210538-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	2020-09-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210538-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	2020-09-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210538-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	2020-09-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210538-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	2020-09-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210538-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	2020-09-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210538-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	2020-09-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210538-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	2020-09-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210538-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	2020-09-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210538-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	2020-09-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210538-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	2020-09-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210538-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	2020-09-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210538-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	2020-09-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210538-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	2020-09-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210538-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	2020-09-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210538-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	2020-09-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210538-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	2020-09-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210538-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	2020-09-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210538-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	2020-09-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210538-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	2020-09-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210538-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	2020-09-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210538-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	2020-09-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210538-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	2020-09-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210538-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	2020-09-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210538-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	2020-09-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210538-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	2020-09-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210538-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	2020-09-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210538-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	2020-09-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210538-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	2020-09-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210538-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	2020-09-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210538-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	2020-09-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210538-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	2020-09-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210538-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	2020-09-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210538-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	2020-09-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210538-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	2020-09-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210538-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	2020-09-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210538-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	2020-09-24	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A210538-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	2020-09-24	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210538-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	2020-09-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210538-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	2020-09-24	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A210538-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	2020-09-24	`782e0a99824c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2021-03-12 10:30 UTC	2021-03	A210538-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A210538-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210538-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A210538-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210538-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A210538-002	AB	1	`c0c555d07b60…`

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
70710-1416-3	dimethyl fumarate	1 in 1 KIT	KIT	1		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70710-1416	DIMETHYL FUMARATE (DIMETHYL FUMARATE) KIT DIMETHYL FUMARATE CAPSULE, DELAYED RELEASE [ZYDUS PHARMACEUTICALS USA INC.]	5	Legacy NDC, 1 package rows	20250403_e7ef9b9e-d97a-4a56-b792-a1a255613156.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	Zydus Pharmaceuticals USA Inc.	e7ef9b9e-d97a-4a56-b792-a1a255613156	2025-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210538 application number: ANDA210538 ndc (product): 70710-1416
dimethyl fumarate	DIMETHYL FUMARATE	Zydus Lifesciences Limited	7203a262-de0f-42dd-b4fb-8856758b82e9	2025-04-01		Exact identifier application applno (ANDA): 210538 application number: ANDA210538

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	e7ef9b9e-d97a-4a56-b792-a1a255613156	5
1373483	dimethyl fumarate 120 MG Delayed Release Oral Capsule	PSN	e7ef9b9e-d97a-4a56-b792-a1a255613156	5
1373491	dimethyl fumarate 240 MG Delayed Release Oral Capsule	PSN	e7ef9b9e-d97a-4a56-b792-a1a255613156	5
1373497	dimethyl fumarate starter dose 120 MG (14), 240 MG (46) Delayed Release Oral Capsule 60 Count Pack	PSN	e7ef9b9e-d97a-4a56-b792-a1a255613156	5
1373483	dimethyl fumarate 120 MG Delayed Release Oral Capsule	SCD	e7ef9b9e-d97a-4a56-b792-a1a255613156	5
1373491	dimethyl fumarate 240 MG Delayed Release Oral Capsule	SCD	e7ef9b9e-d97a-4a56-b792-a1a255613156	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70710-1416-3	70710141603	1 KIT in 1 KIT (70710-1416-3) * 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE * 46 CAPSULE, DELAYED RELEASE in 1 BOTTLE	1 kit	2020-09-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
dimethyl fumarate	Zydus Pharmaceuticals USA Inc. \| Zydus Lifesciences Limited	2025-04-01	HUMAN PRESCRIPTION DRUG LABEL	5