Demser

Product NDC: 25010-305
11-digit product format: 250100305
Labeler code: 25010
Product ID: 25010-305_7997d826-eb49-4688-9833-e668985c1e74
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: metyrosine
Dosage form: CAPSULE
Route: ORAL
Labeler: Bausch Health US, LLC
Application: NDA017871
Marketing category: NDA
Marketing start: 1979-10-03
Substance: METYROSINE
Active strength: 250 mg/1
Pharmacologic classes: Catecholamine Synthesis Inhibitor [EPC], Catecholamine Synthesis Inhibitors [MoA]
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N017871-001	DEMSER	METYROSINE	250MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N017871-001	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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N017871-001	DEMSER	250MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017871-001	DEMSER	250MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017871-001	DEMSER	250MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017871-001	DEMSER	250MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017871-001	DEMSER	250MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017871-001	DEMSER	250MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017871-001	DEMSER	250MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017871-001	DEMSER	250MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017871-001	DEMSER	250MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017871-001	DEMSER	250MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017871-001	DEMSER	250MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017871-001	DEMSER	250MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017871-001	DEMSER	250MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N017871-001	DEMSER	250MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017871-001	DEMSER	250MG	CAPSULE / ORAL		RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N017871-001	DEMSER	250MG	CAPSULE / ORAL		RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N017871-001	DEMSER	250MG	CAPSULE / ORAL		RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N017871-001	DEMSER	250MG	CAPSULE / ORAL		RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N017871-001	DEMSER	250MG	CAPSULE / ORAL		RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N017871-001	DEMSER	250MG	CAPSULE / ORAL		RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017871-001	DEMSER	250MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N017871-001	DEMSER	250MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N017871-001	DEMSER	250MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N017871-001	DEMSER	250MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N017871-001	DEMSER	250MG	CAPSULE / ORAL		RLD, RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N017871-001	DEMSER	250MG	CAPSULE / ORAL		RLD, RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N017871-001	DEMSER	250MG	CAPSULE / ORAL		RLD, RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N017871-001	DEMSER	250MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N017871-001	DEMSER	250MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N017871-001	DEMSER	250MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N017871-001	DEMSER	250MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N017871-001	DEMSER	250MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N017871-001	DEMSER	250MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N017871-001	DEMSER	250MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N017871-001	DEMSER	250MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N017871-001	DEMSER	250MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N017871-001	DEMSER	250MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N017871-001	DEMSER	250MG	CAPSULE / ORAL		RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N017871-001	DEMSER	250MG	CAPSULE / ORAL		RLD, RS, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N017871-001	DEMSER	250MG	CAPSULE / ORAL		RLD, RS, Approved before 1982	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N017871-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017871-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017871-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017871-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017871-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017871-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017871-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017871-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017871-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017871-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017871-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017871-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017871-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N017871-001	AB	1	`8072bd15b7f6…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017871-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N017871-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N017871-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N017871-001	AB	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N017871-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N017871-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N017871-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N017871-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N017871-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N017871-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N017871-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N017871-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N017871-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N017871-001	AB	1	`3a93d1ddd44b…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N017871-001	AB	1	`a50c72e98297…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
METYROSINE	250 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
DOQ0J0TPF7	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197980	Internal RxNorm lookup
201388	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
32fb2f2f-34b5-4cd5-9145-c3ab37c5ca92	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c854e70c-e05b-1969-e1ff-89d3d09d1b16	Product name	4	20260122

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
25010-305-15	Demser	100 in 1 BOTTLE	CAPSULE	100		10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
25010-305-15	EA - Each	25010-305	d521d874-0251-4f94-a8bc-da30465a369d	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
metyrosine	ACTIVE INGREDIENT	DOQ0J0TPF7	DEMSER (METYROSINE) CAPSULE [ATON PHARMA, INC.]	3
metyrosine	ACTIVE MOIETY	DOQ0J0TPF7	DEMSER (METYROSINE) CAPSULE [ATON PHARMA, INC.]	3
FD&C Blue No. 2	INACTIVE INGREDIENT	L06K8R7DQK	DEMSER (METYROSINE) CAPSULE [ATON PHARMA, INC.]	3
gelatin	INACTIVE INGREDIENT	2G86QN327L	DEMSER (METYROSINE) CAPSULE [ATON PHARMA, INC.]	3
hydroxypropyl cellulose	INACTIVE INGREDIENT	RFW2ET671P	DEMSER (METYROSINE) CAPSULE [ATON PHARMA, INC.]	3
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	DEMSER (METYROSINE) CAPSULE [ATON PHARMA, INC.]	3
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	DEMSER (METYROSINE) CAPSULE [ATON PHARMA, INC.]	3
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	DEMSER (METYROSINE) CAPSULE [ATON PHARMA, INC.]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
25010-305	DEMSER (METYROSINE) CAPSULE [BAUSCH HEALTH US, LLC]	10	Current NDC, Legacy NDC, 1 package rows	20210915_32fb2f2f-34b5-4cd5-9145-c3ab37c5ca92.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
Demser	METYROSINE	Bausch Health US, LLC	32fb2f2f-34b5-4cd5-9145-c3ab37c5ca92	2021-07-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 017871 application number: NDA017871 ndc (product): 25010-305
Metyrosine	METYROSINE	Oceanside Pharmaceuticals	46612725-bee0-4125-b8b5-9fed9c003ed4	2021-07-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 017871 application number: NDA017871

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
DOQ0J0TPF7	METYROSINE	672-87-7	METYROSINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
201388	Demser 250 MG Oral Capsule	PSN	32fb2f2f-34b5-4cd5-9145-c3ab37c5ca92	10
197980	metyroSINE 250 MG Oral Capsule	PSN	32fb2f2f-34b5-4cd5-9145-c3ab37c5ca92	10
201388	metyrosine 250 MG Oral Capsule [Demser]	SBD	32fb2f2f-34b5-4cd5-9145-c3ab37c5ca92	10
197980	metyrosine 250 MG Oral Capsule	SCD	32fb2f2f-34b5-4cd5-9145-c3ab37c5ca92	10
201388	Demser 250 MG Oral Capsule	SY	32fb2f2f-34b5-4cd5-9145-c3ab37c5ca92	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
25010-305-15	25010030515	100 CAPSULE in 1 BOTTLE (25010-305-15)	100 capsule	1979-10-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DEMSER ® (metyrosine) Capsules	Bausch Health US, LLC \| Bausch Health Companies Inc.	2021-07-01	HUMAN PRESCRIPTION DRUG LABEL	10