Methimazole

Product NDC: 68071-5197
11-digit product format: 680715197
Labeler code: 68071
Product ID: 68071-5197_d7732452-c96b-1a18-e053-2995a90a84a8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Methimazole
Dosage form: TABLET
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA040734
Marketing category: ANDA
Marketing start: 2012-01-15
Marketing end: 0000-00-00
Substance: METHIMAZOLE
Active strength: 10 mg/1
Pharmacologic classes: Thyroid Hormone Synthesis Inhibitor [EPC], Thyroid Hormone Synthesis Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2023-12-31
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	68071-5197		D	Discontinued by firm		2026-08-03
excluded package	package	68071-5197	68071-5197-1	D	Discontinued by firm		2026-08-03

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 · 24 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	68071-5197-1	`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	68071-5197-1	`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	68071-5197-1	`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	68071-5197-1	`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	68071-5197-1	`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	68071-5197-1	`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	68071-5197-1	`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	68071-5197-1	`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	68071-5197-1	`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	68071-5197-1	`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	68071-5197-1	`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	68071-5197-1	`557ba5c1ecfa…`	`9c80585c8c6e…`

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A040734-001	METHIMAZOLE	METHIMAZOLE	5MG	TABLET / ORAL	AB		2007-12-14
A040734-002	METHIMAZOLE	METHIMAZOLE	10MG	TABLET / ORAL	AB		2007-12-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040734-001	AB
A040734-002	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 3 · 82 observed 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	A040734-001	METHIMAZOLE	5MG	TABLET / ORAL	AB	2007-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040734-002	METHIMAZOLE	10MG	TABLET / ORAL	AB	2007-12-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040734-001	METHIMAZOLE	5MG	TABLET / ORAL	AB	2007-12-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040734-002	METHIMAZOLE	10MG	TABLET / ORAL	AB	2007-12-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040734-001	METHIMAZOLE	5MG	TABLET / ORAL	AB	2007-12-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040734-002	METHIMAZOLE	10MG	TABLET / ORAL	AB	2007-12-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040734-001	METHIMAZOLE	5MG	TABLET / ORAL	AB	2007-12-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040734-002	METHIMAZOLE	10MG	TABLET / ORAL	AB	2007-12-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040734-001	METHIMAZOLE	5MG	TABLET / ORAL	AB	2007-12-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040734-002	METHIMAZOLE	10MG	TABLET / ORAL	AB	2007-12-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040734-001	METHIMAZOLE	5MG	TABLET / ORAL	AB	2007-12-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040734-002	METHIMAZOLE	10MG	TABLET / ORAL	AB	2007-12-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040734-001	METHIMAZOLE	5MG	TABLET / ORAL	AB	2007-12-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040734-002	METHIMAZOLE	10MG	TABLET / ORAL	AB	2007-12-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040734-001	METHIMAZOLE	5MG	TABLET / ORAL	AB	2007-12-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040734-002	METHIMAZOLE	10MG	TABLET / ORAL	AB	2007-12-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040734-001	METHIMAZOLE	5MG	TABLET / ORAL	AB	2007-12-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040734-002	METHIMAZOLE	10MG	TABLET / ORAL	AB	2007-12-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040734-001	METHIMAZOLE	5MG	TABLET / ORAL	AB	2007-12-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040734-002	METHIMAZOLE	10MG	TABLET / ORAL	AB	2007-12-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040734-001	METHIMAZOLE	5MG	TABLET / ORAL	AB	2007-12-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040734-002	METHIMAZOLE	10MG	TABLET / ORAL	AB	2007-12-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040734-001	METHIMAZOLE	5MG	TABLET / ORAL	AB	2007-12-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040734-002	METHIMAZOLE	10MG	TABLET / ORAL	AB	2007-12-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040734-001	METHIMAZOLE	5MG	TABLET / ORAL	AB	2007-12-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040734-002	METHIMAZOLE	10MG	TABLET / ORAL	AB	2007-12-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040734-001	METHIMAZOLE	5MG	TABLET / ORAL	AB	2007-12-14	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040734-002	METHIMAZOLE	10MG	TABLET / ORAL	AB	2007-12-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040734-001	METHIMAZOLE	5MG	TABLET / ORAL	AB	2007-12-14	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040734-002	METHIMAZOLE	10MG	TABLET / ORAL	AB	2007-12-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040734-001	METHIMAZOLE	5MG	TABLET / ORAL	AB	2007-12-14	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040734-002	METHIMAZOLE	10MG	TABLET / ORAL	AB	2007-12-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040734-001	METHIMAZOLE	5MG	TABLET / ORAL	AB	2007-12-14	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040734-002	METHIMAZOLE	10MG	TABLET / ORAL	AB	2007-12-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040734-001	METHIMAZOLE	5MG	TABLET / ORAL	AB	2007-12-14	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040734-002	METHIMAZOLE	10MG	TABLET / ORAL	AB	2007-12-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040734-001	METHIMAZOLE	5MG	TABLET / ORAL	AB	2007-12-14	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040734-002	METHIMAZOLE	10MG	TABLET / ORAL	AB	2007-12-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040734-001	METHIMAZOLE	5MG	TABLET / ORAL	AB	2007-12-14	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A040734-002	METHIMAZOLE	10MG	TABLET / ORAL	AB	2007-12-14	`782e0a99824c…`

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	A040734-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040734-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040734-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040734-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040734-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040734-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040734-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040734-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040734-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040734-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040734-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040734-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040734-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040734-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040734-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040734-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040734-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040734-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040734-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040734-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040734-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040734-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040734-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040734-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040734-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040734-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040734-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040734-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040734-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040734-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040734-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040734-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040734-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040734-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040734-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040734-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040734-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040734-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040734-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A040734-002	AB	1	`782e0a99824c…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68071-5197-1	2022-02-07	C162847	48780-1	d6a99b39-8760-a426-e053-dadaa90af4c2	Rx only
68071-5197-1	2022-01-28	C162847	48780-1	d6a99b39-8760-a426-e053-dadaa90af4c2	Rx only

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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Methimazole	METHIMAZOLE	REMEDYREPACK INC.	b53f84ac-4263-478c-883d-aca7ab44fef5	2026-07-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040734 application number: ANDA040734
Methimazole	METHIMAZOLE	REMEDYREPACK INC.	2c6a9c70-4ed6-4f05-bc3d-e8e7aca57c2b	2026-07-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040734 application number: ANDA040734
Methimazole	METHIMAZOLE	Preferred Pharmaceuticals Inc.	c1e6f1ee-238c-466e-b223-3c3f63dac9ed	2026-06-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040734 application number: ANDA040734
Methimazole	METHIMAZOLE	Preferred Pharmaceuticals Inc.	244d76f1-98e6-4305-8768-b104f6a4be07	2026-06-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040734 application number: ANDA040734
Methimazole	METHIMAZOLE	Proficient Rx LP	e921f23b-a9bf-4313-9cfa-f0b29c06f72a	2025-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040734 application number: ANDA040734
Methimazole	METHIMAZOLE	Golden State Medical Supply, Inc.	4eff3321-2fce-4bab-94af-7b16e333beed	2024-09-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040734 application number: ANDA040734
Methimazole	METHIMAZOLE	NORTHSTAR RX LLC	923fec30-90fd-4bd5-beb3-f2ca4fc171ee	2024-06-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040734 application number: ANDA040734
Methimazole	METHIMAZOLE	Bryant Ranch Prepack	381052c4-891c-4ae4-b63e-65229126cbca	2023-11-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040734 application number: ANDA040734
Methimazole	METHIMAZOLE	Bryant Ranch Prepack	3ca961ca-cbf2-4a73-8c81-4205e01b2695	2023-11-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040734 application number: ANDA040734
Methimazole	METHIMAZOLE	A-S Medication Solutions	87eb663e-5dd3-4a7a-8b28-7e19c5ad1173	2023-06-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040734 application number: ANDA040734
Methimazole	METHIMAZOLE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	8c3a9aaa-cdde-404b-9af6-5a88ef649aac	2022-03-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040734 application number: ANDA040734

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-5197-1	68071519701	100 TABLET in 1 BOTTLE (68071-5197-1)	100 tablet	2020-03-10	0000-00-00	No	No	Current