Methimazole

Product NDC: 68788-8883
Requested package NDC: 68788-8883-3
11-digit product format: 687888883
Labeler code: 68788
Product ID: 68788-8883_c063f4c0-d5fe-4b28-b14d-78f73cd7f2c3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: methimazole
Dosage form: TABLET
Route: ORAL
Labeler: Preferred Pharmaceuticals Inc.
Application: ANDA202068
Marketing category: ANDA
Marketing start: 2025-06-02
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 43.

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
A202068-001	METHIMAZOLE	METHIMAZOLE	5MG	TABLET / ORAL	AB		2012-03-07
A202068-002	METHIMAZOLE	METHIMAZOLE	10MG	TABLET / ORAL	AB		2012-03-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202068-001	AB
A202068-002	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 · 86 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
2026-09-14 22:38:34	2026-08	A202068-001	METHIMAZOLE	5MG	TABLET / ORAL	AB	2012-03-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202068-002	METHIMAZOLE	10MG	TABLET / ORAL	AB	2012-03-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202068-001	METHIMAZOLE	5MG	TABLET / ORAL	AB	2012-03-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202068-002	METHIMAZOLE	10MG	TABLET / ORAL	AB	2012-03-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202068-001	METHIMAZOLE	5MG	TABLET / ORAL	AB	2012-03-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202068-002	METHIMAZOLE	10MG	TABLET / ORAL	AB	2012-03-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202068-001	METHIMAZOLE	5MG	TABLET / ORAL	AB	2012-03-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202068-002	METHIMAZOLE	10MG	TABLET / ORAL	AB	2012-03-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202068-001	METHIMAZOLE	5MG	TABLET / ORAL	AB	2012-03-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202068-002	METHIMAZOLE	10MG	TABLET / ORAL	AB	2012-03-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202068-001	METHIMAZOLE	5MG	TABLET / ORAL	AB	2012-03-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202068-002	METHIMAZOLE	10MG	TABLET / ORAL	AB	2012-03-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202068-001	METHIMAZOLE	5MG	TABLET / ORAL	AB	2012-03-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202068-002	METHIMAZOLE	10MG	TABLET / ORAL	AB	2012-03-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202068-001	METHIMAZOLE	5MG	TABLET / ORAL	AB	2012-03-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202068-002	METHIMAZOLE	10MG	TABLET / ORAL	AB	2012-03-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202068-001	METHIMAZOLE	5MG	TABLET / ORAL	AB	2012-03-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202068-002	METHIMAZOLE	10MG	TABLET / ORAL	AB	2012-03-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202068-001	METHIMAZOLE	5MG	TABLET / ORAL	AB	2012-03-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202068-002	METHIMAZOLE	10MG	TABLET / ORAL	AB	2012-03-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202068-001	METHIMAZOLE	5MG	TABLET / ORAL	AB	2012-03-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202068-002	METHIMAZOLE	10MG	TABLET / ORAL	AB	2012-03-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202068-001	METHIMAZOLE	5MG	TABLET / ORAL	AB	2012-03-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202068-002	METHIMAZOLE	10MG	TABLET / ORAL	AB	2012-03-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202068-001	METHIMAZOLE	5MG	TABLET / ORAL	AB	2012-03-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202068-002	METHIMAZOLE	10MG	TABLET / ORAL	AB	2012-03-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202068-001	METHIMAZOLE	5MG	TABLET / ORAL	AB	2012-03-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202068-002	METHIMAZOLE	10MG	TABLET / ORAL	AB	2012-03-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202068-001	METHIMAZOLE	5MG	TABLET / ORAL	AB	2012-03-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202068-002	METHIMAZOLE	10MG	TABLET / ORAL	AB	2012-03-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202068-001	METHIMAZOLE	5MG	TABLET / ORAL	AB	2012-03-07	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202068-002	METHIMAZOLE	10MG	TABLET / ORAL	AB	2012-03-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202068-001	METHIMAZOLE	5MG	TABLET / ORAL	AB	2012-03-07	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202068-002	METHIMAZOLE	10MG	TABLET / ORAL	AB	2012-03-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202068-001	METHIMAZOLE	5MG	TABLET / ORAL	AB	2012-03-07	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202068-002	METHIMAZOLE	10MG	TABLET / ORAL	AB	2012-03-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202068-001	METHIMAZOLE	5MG	TABLET / ORAL	AB	2012-03-07	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202068-002	METHIMAZOLE	10MG	TABLET / ORAL	AB	2012-03-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202068-001	METHIMAZOLE	5MG	TABLET / ORAL	AB	2012-03-07	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202068-002	METHIMAZOLE	10MG	TABLET / ORAL	AB	2012-03-07	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A202068-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202068-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202068-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202068-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202068-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202068-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202068-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202068-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202068-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202068-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202068-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202068-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202068-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202068-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202068-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202068-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202068-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202068-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202068-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202068-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202068-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202068-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202068-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202068-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202068-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202068-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202068-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202068-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202068-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202068-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202068-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202068-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202068-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202068-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202068-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202068-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202068-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202068-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202068-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202068-002	AB	1	`74a2ff9319b5…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Methimazole
Listing expiration: 2026-12-31

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
c063f4c0-d5fe-4b28-b14d-78f73cd7f2c3	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
68788-8883-1	Methimazole	100 in 1 BOTTLE	TABLET	100		1
68788-8883-3	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
68788-8883-1	EA - Each	68788-8883	02db343f-f8f7-4c69-aea3-682452552179	1	2025-07-08
68788-8883-3	EA - Each	68788-8883	162d6187-2769-4588-a2f4-47063ce5ade4	1	2025-07-08

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Methimazole	METHIMAZOLE	Preferred Pharmaceuticals Inc.	253088bf-00f2-489b-984a-682ef9d89e90	2026-01-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202068 application number: ANDA202068
Methimazole	METHIMAZOLE	Preferred Pharmaceuticals Inc.	c063f4c0-d5fe-4b28-b14d-78f73cd7f2c3	2025-06-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202068 application number: ANDA202068 ndc (package): 68788-8883-3 ndc (product): 68788-8883 ndc11 (package): 68788888303
Methimazole	METHIMAZOLE	Bryant Ranch Prepack	f74a8e69-79a1-4061-b42f-447e0780c04f	2025-05-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202068 application number: ANDA202068
Methimazole	METHIMAZOLE	Rising Pharma Holdings, Inc.	289ec852-176e-41aa-9f9a-b1f9b4196771	2025-03-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202068 application number: ANDA202068

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	c063f4c0-d5fe-4b28-b14d-78f73cd7f2c3	1
197942	methimazole 5 MG Oral Tablet	SCD	c063f4c0-d5fe-4b28-b14d-78f73cd7f2c3	1
197942	thiamazole 5 MG Oral Tablet	SY	c063f4c0-d5fe-4b28-b14d-78f73cd7f2c3	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
68788-8883-3	68788888303	30 TABLET in 1 BOTTLE (68788-8883-3)	30 tablet	2025-06-02	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Methimazole Tablets, USP Rx only	Preferred Pharmaceuticals Inc.	2025-06-02	HUMAN PRESCRIPTION DRUG LABEL	1