metyrosine

Product NDC: 69238-1621
11-digit product format: 692381621
Labeler code: 69238
Product ID: 69238-1621_30339825-d8d3-4000-ad4d-edbbd76c4e25
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: metyrosine
Dosage form: CAPSULE
Route: ORAL
Labeler: Amneal Pharmaceuticals NY LLC
Application: ANDA213734
Marketing category: ANDA
Marketing start: 2020-07-24
Substance: METYROSINE
Active strength: 250 mg/1
Pharmacologic classes: Catecholamine Synthesis Inhibitor [EPC], Catecholamine Synthesis Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2027-12-31
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
A213734-001	METYROSINE	METYROSINE	250MG	CAPSULE / ORAL	AB		2020-07-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213734-001	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A213734-001	METYROSINE	250MG	CAPSULE / ORAL	AB	2020-07-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213734-001	METYROSINE	250MG	CAPSULE / ORAL	AB	2020-07-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213734-001	METYROSINE	250MG	CAPSULE / ORAL	AB	2020-07-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213734-001	METYROSINE	250MG	CAPSULE / ORAL	AB	2020-07-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213734-001	METYROSINE	250MG	CAPSULE / ORAL	AB	2020-07-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213734-001	METYROSINE	250MG	CAPSULE / ORAL	AB	2020-07-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213734-001	METYROSINE	250MG	CAPSULE / ORAL	AB	2020-07-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213734-001	METYROSINE	250MG	CAPSULE / ORAL	AB	2020-07-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213734-001	METYROSINE	250MG	CAPSULE / ORAL	AB	2020-07-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213734-001	METYROSINE	250MG	CAPSULE / ORAL	AB	2020-07-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213734-001	METYROSINE	250MG	CAPSULE / ORAL	AB	2020-07-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213734-001	METYROSINE	250MG	CAPSULE / ORAL	AB	2020-07-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213734-001	METYROSINE	250MG	CAPSULE / ORAL	AB	2020-07-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213734-001	METYROSINE	250MG	CAPSULE / ORAL	AB	2020-07-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213734-001	METYROSINE	250MG	CAPSULE / ORAL	BX	2020-07-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213734-001	METYROSINE	250MG	CAPSULE / ORAL	BX	2020-07-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213734-001	METYROSINE	250MG	CAPSULE / ORAL	BX	2020-07-24	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213734-001	METYROSINE	250MG	CAPSULE / ORAL	BX	2020-07-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213734-001	METYROSINE	250MG	CAPSULE / ORAL	BX	2020-07-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213734-001	METYROSINE	250MG	CAPSULE / ORAL	AB	2020-07-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A213734-001	METYROSINE	250MG	CAPSULE / ORAL	AB	2020-07-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A213734-001	METYROSINE	250MG	CAPSULE / ORAL	AB	2020-07-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A213734-001	METYROSINE	250MG	CAPSULE / ORAL	AB	2020-07-24	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213734-001	METYROSINE	250MG	CAPSULE / ORAL	AB	2020-07-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213734-001	METYROSINE	250MG	CAPSULE / ORAL	AB	2020-07-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213734-001	METYROSINE	250MG	CAPSULE / ORAL	AB	2020-07-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213734-001	METYROSINE	250MG	CAPSULE / ORAL	AB	2020-07-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213734-001	METYROSINE	250MG	CAPSULE / ORAL	AB	2020-07-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213734-001	METYROSINE	250MG	CAPSULE / ORAL	AB	2020-07-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213734-001	METYROSINE	250MG	CAPSULE / ORAL	AB	2020-07-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213734-001	METYROSINE	250MG	CAPSULE / ORAL	AB	2020-07-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213734-001	METYROSINE	250MG	CAPSULE / ORAL	AB	2020-07-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213734-001	METYROSINE	250MG	CAPSULE / ORAL	AB	2020-07-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213734-001	METYROSINE	250MG	CAPSULE / ORAL	BX	2020-07-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213734-001	METYROSINE	250MG	CAPSULE / ORAL	BX	2020-07-24	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213734-001	METYROSINE	250MG	CAPSULE / ORAL	BX	2020-07-24	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213734-001	METYROSINE	250MG	CAPSULE / ORAL	AB	2020-07-24	`a50c72e98297…`

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	A213734-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213734-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213734-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213734-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213734-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213734-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213734-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213734-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213734-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213734-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213734-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213734-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213734-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213734-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213734-001	BX	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213734-001	BX	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213734-001	BX	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213734-001	BX	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213734-001	BX	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213734-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A213734-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A213734-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A213734-001	AB	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213734-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213734-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213734-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213734-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213734-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213734-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213734-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213734-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213734-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213734-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213734-001	BX	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213734-001	BX	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213734-001	BX	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213734-001	AB	1	`a50c72e98297…`

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	A213734-001	CGT	2021-01-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213734-001	CGT	2021-01-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A213734-001	CGT	2021-01-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A213734-001	CGT	2021-01-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A213734-001	CGT	2021-01-20	`c0c555d07b60…`

Additional Listing Data#

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

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197980	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
027f02b1-be49-4822-91a5-6cd66b56c0e1	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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727
7792dadb-52b6-46b6-8fdf-80b1171065b5	Product name	1	20180810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69238-1621-1	metyrosine	100 in 1 BOTTLE, PLASTIC	CAPSULE	100		7
69238-1621-3	metyrosine	30 in 1 BOTTLE, PLASTIC	CAPSULE	30		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69238-1621-3	EA - Each	69238-1621	d94d9cb1-1929-493d-afd1-b7a61a93211d	1	2021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69238-1621	METYROSINE CAPSULE [AMNEAL PHARMACEUTICALS NY LLC]	6	Current NDC, Legacy NDC, 2 package rows	20230112_027f02b1-be49-4822-91a5-6cd66b56c0e1.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
metyrosine	METYROSINE	Amneal Pharmaceuticals NY LLC	027f02b1-be49-4822-91a5-6cd66b56c0e1	2026-04-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213734 application number: ANDA213734 ndc (product): 69238-1621

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
197980	metyroSINE 250 MG Oral Capsule	PSN	027f02b1-be49-4822-91a5-6cd66b56c0e1	7
197980	metyrosine 250 MG Oral Capsule	SCD	027f02b1-be49-4822-91a5-6cd66b56c0e1	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69238-1621-1	69238162101	100 CAPSULE in 1 BOTTLE, PLASTIC (69238-1621-1)	100 capsule	2020-07-24	0000-00-00	No	No	Current
69238-1621-3	69238162103	30 CAPSULE in 1 BOTTLE, PLASTIC (69238-1621-3)	30 capsule	2020-12-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Metyrosine Capsules, USP (250 mg) Rx Only	Amneal Pharmaceuticals NY LLC	2026-04-14	HUMAN PRESCRIPTION DRUG LABEL	7