metyrosine

Product NDC: 60219-1621
Requested package NDC: 60219-1621-1
11-digit product format: 602191621
Labeler code: 60219
Product ID: 60219-1621_d533653d-aa45-4c53-8440-08b2178e64dc
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
Marketing end: 0000-00-00
Substance: METYROSINE
Active strength: 250 mg/1
Pharmacologic classes: Catecholamine Synthesis Inhibitor [EPC],Catecholamine Synthesis Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2021-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	60219-1621	60219-1621-1	I	Inactivated by FDA		2026-08-11

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 · 18 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	`bd6a592717d7…`	`303034d00443…`

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…`

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
60219-1621-1	2022-01-28	C162847	48780-1	d6a99b39-fe65-a426-e053-dadaa90af4c2	Metyrosine Capsules, USP (250 mg) Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
60219-1621-1	metyrosine	100 in 1 BOTTLE, PLASTIC	CAPSULE	100		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60219-1621-1	EA - Each	60219-1621	c5fd349c-daa7-427f-b907-40400044ee38	1	2020-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60219-1621	METYROSINE CAPSULE [AMNEAL PHARMACEUTICALS NY LLC]	4	Legacy NDC, 1 package rows	20201105_ab57037b-11ca-45c5-ac6e-deea64990375.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

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	ab57037b-11ca-45c5-ac6e-deea64990375	4
197980	metyrosine 250 MG Oral Capsule	SCD	ab57037b-11ca-45c5-ac6e-deea64990375	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
60219-1621-1	60219162101	100 CAPSULE in 1 BOTTLE, PLASTIC (60219-1621-1)	100 capsule	2020-07-24	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	2020-11-03	HUMAN PRESCRIPTION DRUG LABEL	4