Methimazole

Product NDC: 68788-8226
11-digit product format: 687888226
Labeler code: 68788
Product ID: 68788-8226_8151209d-8832-4a7b-8b4c-cc32c62ffeea
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Methimazole
Dosage form: TABLET
Route: ORAL
Labeler: Preferred Pharmaceuticals Inc.
Application: ANDA040734
Marketing category: ANDA
Marketing start: 2022-08-08
Substance: METHIMAZOLE
Active strength: 5 mg/1
Pharmacologic classes: Thyroid Hormone Synthesis Inhibitor [EPC], Thyroid Hormone 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 · 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…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
METHIMAZOLE	5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
554Z48XN5E	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197942	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
c1e6f1ee-238c-466e-b223-3c3f63dac9ed	Available on FDA.report

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68788-8226-3	Methimazole	30 in 1 BOTTLE	TABLET	30		4
68788-8226-6	Methimazole	60 in 1 BOTTLE	TABLET	60		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68788-8226-3	EA - Each	68788-8226	b45e2cd8-b233-4ff2-a40b-e402d8ca1151	1	2022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-8226	METHIMAZOLE TABLET [PREFERRED PHARMACEUTICALS INC.]	3	Current NDC, Legacy NDC, 2 package rows	20240712_c1e6f1ee-238c-466e-b223-3c3f63dac9ed.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 · 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 ndc (product): 68788-8226
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197942	methIMAzole 5 MG Oral Tablet	PSN	c1e6f1ee-238c-466e-b223-3c3f63dac9ed	4
197942	methimazole 5 MG Oral Tablet	SCD	c1e6f1ee-238c-466e-b223-3c3f63dac9ed	4
197942	thiamazole 5 MG Oral Tablet	SY	c1e6f1ee-238c-466e-b223-3c3f63dac9ed	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68788-8226-3	68788822603	30 TABLET in 1 BOTTLE (68788-8226-3)	30 tablet	2022-08-08	0000-00-00	No	No	Current
68788-8226-6	68788822606	60 TABLET in 1 BOTTLE (68788-8226-6)	60 tablet	2022-08-08	0000-00-00	No	No	Current