BAFIERTAM

Product NDC: 69387-001
11-digit product format: 693870001
Labeler code: 69387
Product ID: 69387-001_9ebcd7d7-1863-47e9-9c0d-2637d7f4f5af
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: monomethyl fumarate
Dosage form: CAPSULE
Route: ORAL
Labeler: Banner Life Sciences LLC
Application: NDA210296
Marketing category: NDA
Marketing start: 2020-04-28
Substance: MONOMETHYL FUMARATE
Active strength: 95 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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N210296-001	BAFIERTAM	MONOMETHYL FUMARATE	95MG	CAPSULE, DELAYED RELEASE / ORAL		RLD, RS	2020-04-28

Orange Book patents#

Current patent rows page 1 of 1 · 21 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N210296-001	10098863	2035-02-27	U-1384	Drug product	2020-05-21
N210296-001	10105335	2035-02-27		Drug product	2020-05-21
N210296-001	10105336	2035-02-27	U-1384	Drug product	2020-05-21
N210296-001	10105337	2035-02-27		Drug product	2020-05-21
N210296-001	10918615	2035-02-27	U-1384	Drug product	2021-02-19
N210296-001	10918616	2035-02-27	U-1384		2021-02-19
N210296-001	10918617	2035-02-27		Drug product	2021-02-19
N210296-001	10945985	2035-02-27		Drug product	2021-03-03
N210296-001	11590095	2035-02-27	U-1384		2023-03-30
N210296-001	11903918	2035-02-27	U-1384		2024-03-01
N210296-001	9326947	2035-02-27		Drug product	2020-05-21
N210296-001	9326965	2035-02-27	U-1384		2020-05-21
N210296-001	9511043	2035-02-27	U-1384		2020-05-21
N210296-001	9517209	2035-02-27		Drug product	2020-05-21
N210296-001	9566259	2035-02-27		Drug product	2020-05-21
N210296-001	9636318	2035-02-27	U-1384		2020-05-21
N210296-001	9636319	2035-02-27		Drug product	2020-05-21
N210296-001	9814691	2035-02-27	U-1384		2020-05-21
N210296-001	9814692	2035-02-27	U-1384		2020-05-21
N210296-001	9820960	2035-02-27		Drug product	2020-05-21
N210296-001	9820961	2035-02-27	U-1384	Drug product	2020-05-21

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N210296-001	BAFIERTAM	95MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2020-04-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N210296-001	BAFIERTAM	95MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2020-04-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210296-001	BAFIERTAM	95MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2020-04-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N210296-001	BAFIERTAM	95MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2020-04-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210296-001	BAFIERTAM	95MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2020-04-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210296-001	BAFIERTAM	95MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2020-04-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210296-001	BAFIERTAM	95MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2020-04-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210296-001	BAFIERTAM	95MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2020-04-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210296-001	BAFIERTAM	95MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2020-04-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210296-001	BAFIERTAM	95MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2020-04-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N210296-001	BAFIERTAM	95MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2020-04-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N210296-001	BAFIERTAM	95MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2020-04-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N210296-001	BAFIERTAM	95MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2020-04-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N210296-001	BAFIERTAM	95MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2020-04-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N210296-001	BAFIERTAM	95MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2020-04-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N210296-001	BAFIERTAM	95MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2020-04-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N210296-001	BAFIERTAM	95MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2020-04-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N210296-001	BAFIERTAM	95MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2020-04-28	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N210296-001	BAFIERTAM	95MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2020-04-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N210296-001	BAFIERTAM	95MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2020-04-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N210296-001	BAFIERTAM	95MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2020-04-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N210296-001	BAFIERTAM	95MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2020-04-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N210296-001	BAFIERTAM	95MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2020-04-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N210296-001	BAFIERTAM	95MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2020-04-28	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N210296-001	BAFIERTAM	95MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2020-04-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N210296-001	BAFIERTAM	95MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2020-04-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N210296-001	BAFIERTAM	95MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2020-04-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N210296-001	BAFIERTAM	95MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2020-04-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N210296-001	BAFIERTAM	95MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2020-04-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N210296-001	BAFIERTAM	95MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2020-04-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N210296-001	BAFIERTAM	95MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2020-04-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N210296-001	BAFIERTAM	95MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2020-04-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N210296-001	BAFIERTAM	95MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2020-04-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N210296-001	BAFIERTAM	95MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2020-04-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N210296-001	BAFIERTAM	95MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2020-04-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N210296-001	BAFIERTAM	95MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2020-04-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N210296-001	BAFIERTAM	95MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2020-04-28	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N210296-001	BAFIERTAM	95MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2020-04-28	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 19 · 751 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N210296-001	10098863	2035-02-27	U-1384	Drug product	2020-05-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210296-001	10105335	2035-02-27		Drug product	2020-05-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210296-001	10105336	2035-02-27	U-1384	Drug product	2020-05-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210296-001	10105337	2035-02-27		Drug product	2020-05-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210296-001	10918615	2035-02-27	U-1384	Drug product	2021-02-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210296-001	10918616	2035-02-27	U-1384		2021-02-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210296-001	10918617	2035-02-27		Drug product	2021-02-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210296-001	10945985	2035-02-27		Drug product	2021-03-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210296-001	11590095	2035-02-27	U-1384		2023-03-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210296-001	11903918	2035-02-27	U-1384		2024-03-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210296-001	9326947	2035-02-27		Drug product	2020-05-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210296-001	9326965	2035-02-27	U-1384		2020-05-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210296-001	9511043	2035-02-27	U-1384		2020-05-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210296-001	9517209	2035-02-27		Drug product	2020-05-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210296-001	9566259	2035-02-27		Drug product	2020-05-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210296-001	9636318	2035-02-27	U-1384		2020-05-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210296-001	9636319	2035-02-27		Drug product	2020-05-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210296-001	9814691	2035-02-27	U-1384		2020-05-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210296-001	9814692	2035-02-27	U-1384		2020-05-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210296-001	9820960	2035-02-27		Drug product	2020-05-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210296-001	9820961	2035-02-27	U-1384	Drug product	2020-05-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N210296-001	10098863	2035-02-27	U-1384	Drug product	2020-05-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210296-001	10105335	2035-02-27		Drug product	2020-05-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210296-001	10105336	2035-02-27	U-1384	Drug product	2020-05-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210296-001	10105337	2035-02-27		Drug product	2020-05-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210296-001	10918615	2035-02-27	U-1384	Drug product	2021-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210296-001	10918616	2035-02-27	U-1384		2021-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210296-001	10918617	2035-02-27		Drug product	2021-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210296-001	10945985	2035-02-27		Drug product	2021-03-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210296-001	11590095	2035-02-27	U-1384		2023-03-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210296-001	11903918	2035-02-27	U-1384		2024-03-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210296-001	9326947	2035-02-27		Drug product	2020-05-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210296-001	9326965	2035-02-27	U-1384		2020-05-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210296-001	9511043	2035-02-27	U-1384		2020-05-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210296-001	9517209	2035-02-27		Drug product	2020-05-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210296-001	9566259	2035-02-27		Drug product	2020-05-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210296-001	9636318	2035-02-27	U-1384		2020-05-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210296-001	9636319	2035-02-27		Drug product	2020-05-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210296-001	9814691	2035-02-27	U-1384		2020-05-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210296-001	9814692	2035-02-27	U-1384		2020-05-21	`011fe1cb6892…`

Additional Listing Data#

Finished product: Yes
Brand name base: BAFIERTAM
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MONOMETHYL FUMARATE	95 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
45IUB1PX8R	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2393587	Internal RxNorm lookup
2393593	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
a161f9d4-70f1-4097-957a-eafb35d3274f	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
69387-001-01	BAFIERTAM	120 in 1 BOTTLE	CAPSULE	120		10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69387-001-01	EA - Each	69387-001	4d18f8c8-e33e-4119-a91f-5102eb742172	1	2020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69387-001	BAFIERTAM (MONOMETHYL FUMARATE) CAPSULE [BANNER LIFE SCIENCES LLC ]	9	Current NDC, Legacy NDC, 1 package rows	20240517_a161f9d4-70f1-4097-957a-eafb35d3274f.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
BAFIERTAM	MONOMETHYL FUMARATE	Banner Life Sciences LLC	a161f9d4-70f1-4097-957a-eafb35d3274f	2026-07-16	Warnings, Adverse reactions	Exact identifier application applno (NDA): 210296 application number: NDA210296 ndc (product): 69387-001

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
45IUB1PX8R	MONOMETHYL FUMARATE	2756-87-8	MONOMETHYL FUMARATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2393593	Bafiertam 95 MG Delayed Release Oral Capsule	PSN	a161f9d4-70f1-4097-957a-eafb35d3274f	10
2393587	monomethyl fumarate 95 MG Delayed Release Oral Capsule	PSN	a161f9d4-70f1-4097-957a-eafb35d3274f	10
2393593	monomethyl fumarate 95 MG Delayed Release Oral Capsule [Bafiertam]	SBD	a161f9d4-70f1-4097-957a-eafb35d3274f	10
2393587	monomethyl fumarate 95 MG Delayed Release Oral Capsule	SCD	a161f9d4-70f1-4097-957a-eafb35d3274f	10
2393593	Bafiertam 95 MG Delayed Release Oral Capsule	SY	a161f9d4-70f1-4097-957a-eafb35d3274f	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69387-001-01	69387000101	120 CAPSULE in 1 BOTTLE (69387-001-01)	120 capsule	2020-04-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
BAFIERTAM	Banner Life Sciences LLC \| Patheon Softgels Inc.	2026-07-16	HUMAN PRESCRIPTION DRUG LABEL	12