Methimazole

Product NDC: 63629-9251
11-digit product format: 636299251
Labeler code: 63629
Product ID: 63629-9251_71cbfa1e-c9e0-4dc3-94fd-37f4b7b00e75
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: methimazole
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA040350
Marketing category: ANDA
Marketing start: 2022-02-28
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: 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 · 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…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
METHIMAZOLE	10 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
197941	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
d003a93d-da08-4993-bb72-700342ca6e65	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
63629-9251-1	Methimazole	100 in 1 BOTTLE	TABLET	100		103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63629-9251-1	EA - Each	63629-9251	87e42a2d-e023-4c44-ba93-6fdfe32130a9	1	2022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63629-9251	METHIMAZOLE TABLET [BRYANT RANCH PREPACK]	103	Current NDC, Legacy NDC, 1 package rows	20241226_d003a93d-da08-4993-bb72-700342ca6e65.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 ndc (product): 63629-9251
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	d003a93d-da08-4993-bb72-700342ca6e65	103
197941	methimazole 10 MG Oral Tablet	SCD	d003a93d-da08-4993-bb72-700342ca6e65	103
197941	thiamazole 10 MG Oral Tablet	SY	d003a93d-da08-4993-bb72-700342ca6e65	103

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-9251-1	63629925101	100 TABLET in 1 BOTTLE (63629-9251-1)	100 tablet	2022-03-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Methimazole Tablets, USP Rx only	Bryant Ranch Prepack	2024-12-24	HUMAN PRESCRIPTION DRUG LABEL	103