Methimazole

Product NDC: 42254-008
11-digit product format: 422540008
Labeler code: 42254
Product ID: 42254-008_74238d87-5f82-4a5e-a920-a9fc68115e91
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: methimazole
Dosage form: TABLET
Route: ORAL
Labeler: Rebel Distributors Corp.
Application: ANDA040350
Marketing category: ANDA
Marketing start: 2010-07-07
Marketing end: 0000-00-00
Substance: METHIMAZOLE
Active strength: 5 mg/1
Pharmacologic classes: Thyroid Hormone Synthesis Inhibitor [EPC],Thyroid Hormone Synthesis Inhibitors [MoA]
NDC exclude flag: E
Listing certified through: 2017-12-31
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	42254-008		I	Inactivated by FDA		2026-08-11
excluded package	package	42254-008	42254-008-30	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 · 44 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	42254-008-30	`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	42254-008-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	42254-008-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	42254-008-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	42254-008-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	42254-008-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	42254-008-30	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	42254-008-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	42254-008-30	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	42254-008-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	42254-008-30	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	42254-008-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	42254-008-30	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	42254-008-30	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	42254-008-30	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	42254-008-30	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	42254-008-30	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	42254-008-30	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	42254-008-30	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	42254-008-30	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	42254-008-30	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	42254-008-30	`110d247fa046…`	`a55b01930146…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A040350-001	METHIMAZOLE	METHIMAZOLE	5MG	TABLET / ORAL	AB		2000-03-29
A040350-002	METHIMAZOLE	METHIMAZOLE	10MG	TABLET / ORAL	AB	RS	2000-03-29
A040350-003	METHIMAZOLE	METHIMAZOLE	20MG	TABLET / ORAL			2001-06-07

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A040350-001	AB
A040350-002	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 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A040350-001	METHIMAZOLE	5MG	TABLET / ORAL	AB		2000-03-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040350-002	METHIMAZOLE	10MG	TABLET / ORAL	AB	RS	2000-03-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040350-003	METHIMAZOLE	20MG	TABLET / ORAL			2001-06-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040350-001	METHIMAZOLE	5MG	TABLET / ORAL	AB		2000-03-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040350-002	METHIMAZOLE	10MG	TABLET / ORAL	AB	RS	2000-03-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040350-003	METHIMAZOLE	20MG	TABLET / ORAL			2001-06-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040350-001	METHIMAZOLE	5MG	TABLET / ORAL	AB		2000-03-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040350-002	METHIMAZOLE	10MG	TABLET / ORAL	AB	RS	2000-03-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040350-003	METHIMAZOLE	20MG	TABLET / ORAL			2001-06-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040350-001	METHIMAZOLE	5MG	TABLET / ORAL	AB		2000-03-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040350-002	METHIMAZOLE	10MG	TABLET / ORAL	AB	RS	2000-03-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040350-003	METHIMAZOLE	20MG	TABLET / ORAL			2001-06-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040350-001	METHIMAZOLE	5MG	TABLET / ORAL	AB		2000-03-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040350-002	METHIMAZOLE	10MG	TABLET / ORAL	AB	RS	2000-03-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040350-003	METHIMAZOLE	20MG	TABLET / ORAL			2001-06-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040350-001	METHIMAZOLE	5MG	TABLET / ORAL	AB		2000-03-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040350-002	METHIMAZOLE	10MG	TABLET / ORAL	AB	RS	2000-03-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040350-003	METHIMAZOLE	20MG	TABLET / ORAL			2001-06-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040350-001	METHIMAZOLE	5MG	TABLET / ORAL	AB		2000-03-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040350-002	METHIMAZOLE	10MG	TABLET / ORAL	AB	RS	2000-03-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040350-003	METHIMAZOLE	20MG	TABLET / ORAL			2001-06-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040350-001	METHIMAZOLE	5MG	TABLET / ORAL	AB		2000-03-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040350-002	METHIMAZOLE	10MG	TABLET / ORAL	AB	RS	2000-03-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040350-003	METHIMAZOLE	20MG	TABLET / ORAL			2001-06-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040350-001	METHIMAZOLE	5MG	TABLET / ORAL	AB		2000-03-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040350-002	METHIMAZOLE	10MG	TABLET / ORAL	AB	RS	2000-03-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040350-003	METHIMAZOLE	20MG	TABLET / ORAL			2001-06-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040350-001	METHIMAZOLE	5MG	TABLET / ORAL	AB		2000-03-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040350-002	METHIMAZOLE	10MG	TABLET / ORAL	AB	RS	2000-03-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040350-003	METHIMAZOLE	20MG	TABLET / ORAL			2001-06-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040350-001	METHIMAZOLE	5MG	TABLET / ORAL	AB		2000-03-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040350-002	METHIMAZOLE	10MG	TABLET / ORAL	AB	RS	2000-03-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040350-003	METHIMAZOLE	20MG	TABLET / ORAL			2001-06-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040350-001	METHIMAZOLE	5MG	TABLET / ORAL	AB		2000-03-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040350-002	METHIMAZOLE	10MG	TABLET / ORAL	AB	RS	2000-03-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040350-003	METHIMAZOLE	20MG	TABLET / ORAL			2001-06-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040350-001	METHIMAZOLE	5MG	TABLET / ORAL	AB		2000-03-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040350-002	METHIMAZOLE	10MG	TABLET / ORAL	AB	RS	2000-03-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040350-003	METHIMAZOLE	20MG	TABLET / ORAL			2001-06-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040350-001	METHIMAZOLE	5MG	TABLET / ORAL	AB		2000-03-29	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A040350-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040350-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040350-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040350-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040350-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040350-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040350-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040350-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040350-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040350-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040350-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040350-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040350-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040350-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040350-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040350-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040350-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040350-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040350-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040350-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040350-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040350-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040350-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040350-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040350-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040350-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040350-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040350-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040350-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040350-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040350-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040350-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040350-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040350-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040350-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040350-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040350-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040350-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040350-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A040350-002	AB	1	`782e0a99824c…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
42f09d00-d445-e29e-bea8-dfb46b9366fc	Product name	4	20251118

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
42254-008-30	2019-09-24	C162847	48780-1	9350213a-3d3a-c013-e053-90daa90a1393	74238d87-5f82-4a5e-a920-a9fc68115e91

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
42254-008-30	Methimazole	30 in 1 BOTTLE	TABLET	30		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42254-008-30	EA - Each	42254-008	fd70e2be-0f6c-4246-acec-81bfacfc1ff9	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
METHIMAZOLE	ACTIVE INGREDIENT	554Z48XN5E	METHIMAZOLE TABLET [REBEL DISTRIBUTORS CORP.]	1
METHIMAZOLE	ACTIVE MOIETY	554Z48XN5E	METHIMAZOLE TABLET [REBEL DISTRIBUTORS CORP.]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	METHIMAZOLE TABLET [REBEL DISTRIBUTORS CORP.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	METHIMAZOLE TABLET [REBEL DISTRIBUTORS CORP.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	METHIMAZOLE TABLET [REBEL DISTRIBUTORS CORP.]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	METHIMAZOLE TABLET [REBEL DISTRIBUTORS CORP.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42254-008	METHIMAZOLE TABLET [REBEL DISTRIBUTORS CORP.]	1	Legacy NDC, 1 package rows	20111118_74238d87-5f82-4a5e-a920-a9fc68115e91.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 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Methimazole	METHIMAZOLE	Bryant Ranch Prepack	afa2cecc-3fef-4372-8d1e-6bbb06d41b23	2025-12-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040350 application number: ANDA040350
Methimazole	METHIMAZOLE	Bryant Ranch Prepack	3f65518b-33da-48d8-9af2-2a750400b401	2025-12-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040350 application number: ANDA040350
Methimazole	METHIMAZOLE	Bryant Ranch Prepack	d05f7950-84cd-413f-9256-4c0977818d25	2025-11-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040350 application number: ANDA040350
Methimazole	METHIMAZOLE	Bryant Ranch Prepack	1f6970fb-a549-47b0-b812-48109521d713	2025-11-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040350 application number: ANDA040350
Methimazole	METHIMAZOLE	Bryant Ranch Prepack	94d2e57b-685f-4cfd-a5a5-129e869c794c	2025-04-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040350 application number: ANDA040350
Methimazole	METHIMAZOLE	Bryant Ranch Prepack	a86f51a6-1ab8-48c2-a4fc-2439e9986d45	2025-04-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040350 application number: ANDA040350
Methimazole	METHIMAZOLE	American Health Packaging	ca252851-32f2-4eb9-b9f5-82029f0e8c20	2024-12-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040350 application number: ANDA040350
Methimazole	METHIMAZOLE	Bryant Ranch Prepack	d003a93d-da08-4993-bb72-700342ca6e65	2024-12-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040350 application number: ANDA040350
Methimazole	METHIMAZOLE	Bryant Ranch Prepack	e03d32dd-878f-43ee-b8c2-3adad98bf66c	2024-02-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040350 application number: ANDA040350
Methimazole	METHIMAZOLE	Bryant Ranch Prepack	c511344b-cc7f-499b-bb21-5b2312ff311e	2023-02-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040350 application number: ANDA040350
Methimazole	METHIMAZOLE	Bryant Ranch Prepack	6bdf42f6-0ce6-4e05-8962-0019fc7c65a2	2023-02-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040350 application number: ANDA040350
Methimazole	METHIMAZOLE	Strides Pharma Science Limited	0f5fb0a4-feb9-4b86-9a93-b2c84cfc082f	2022-04-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040350 application number: ANDA040350

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
554Z48XN5E	METHIMAZOLE	60-56-0	METHIMAZOLE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197941	methIMAzole 10 MG Oral Tablet	PSN	74238d87-5f82-4a5e-a920-a9fc68115e91	1
197942	methIMAzole 5 MG Oral Tablet	PSN	74238d87-5f82-4a5e-a920-a9fc68115e91	1
197941	methimazole 10 MG Oral Tablet	SCD	74238d87-5f82-4a5e-a920-a9fc68115e91	1
197942	methimazole 5 MG Oral Tablet	SCD	74238d87-5f82-4a5e-a920-a9fc68115e91	1
197941	thiamazole 10 MG Oral Tablet	SY	74238d87-5f82-4a5e-a920-a9fc68115e91	1
197942	thiamazole 5 MG Oral Tablet	SY	74238d87-5f82-4a5e-a920-a9fc68115e91	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
42254-008-30	42254000830	30 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Methimazole - Rebel Distributors Corp.	Rebel Distributors Corp.	2011-10-18	HUMAN PRESCRIPTION DRUG LABEL	1