methimazole

Product NDC: 67046-1652
Requested package NDC: 67046-1652-3
11-digit product format: 670461652
Labeler code: 67046
Product ID: 67046-1652_490f163b-b151-d74b-e063-6394a90ad438
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: methimazole
Dosage form: TABLET
Route: ORAL
Labeler: Coupler LLC
Application: ANDA218830
Marketing category: ANDA
Marketing start: 2026-01-23
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: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A218830-001	METHIMAZOLE	METHIMAZOLE	5MG	TABLET / ORAL	AB		2025-02-05
A218830-002	METHIMAZOLE	METHIMAZOLE	10MG	TABLET / ORAL	AB		2025-02-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A218830-001	AB
A218830-002	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A218830-001	METHIMAZOLE	5MG	TABLET / ORAL	AB	2025-02-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218830-002	METHIMAZOLE	10MG	TABLET / ORAL	AB	2025-02-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A218830-001	METHIMAZOLE	5MG	TABLET / ORAL	AB	2025-02-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218830-002	METHIMAZOLE	10MG	TABLET / ORAL	AB	2025-02-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218830-001	METHIMAZOLE	5MG	TABLET / ORAL	AB	2025-02-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218830-002	METHIMAZOLE	10MG	TABLET / ORAL	AB	2025-02-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A218830-001	METHIMAZOLE	5MG	TABLET / ORAL		2025-02-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218830-002	METHIMAZOLE	10MG	TABLET / ORAL		2025-02-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218830-001	METHIMAZOLE	5MG	TABLET / ORAL	AB	2025-02-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218830-002	METHIMAZOLE	10MG	TABLET / ORAL	AB	2025-02-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218830-001	METHIMAZOLE	5MG	TABLET / ORAL	AB	2025-02-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218830-002	METHIMAZOLE	10MG	TABLET / ORAL	AB	2025-02-05	`b8a1b40f171c…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218830-001	METHIMAZOLE	5MG	TABLET / ORAL	AB	2025-02-05	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218830-002	METHIMAZOLE	10MG	TABLET / ORAL	AB	2025-02-05	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A218830-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218830-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A218830-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218830-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218830-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218830-002	AB	1	`31067a03dcf5…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218830-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218830-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218830-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218830-002	AB	1	`b8a1b40f171c…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218830-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218830-002	AB	1	`a50c72e98297…`

Additional Listing Data#

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

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
490f168f-c703-5497-e063-6294a90ade87	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
67046-1652-3	methimazole	30 in 1 BLISTER PACK	TABLET	30		1

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	Coupler LLC	490f04db-cb51-bde7-e063-6394a90a5546	2026-01-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218830 application number: ANDA218830
methimazole	METHIMAZOLE	Coupler LLC	490f168f-c703-5497-e063-6294a90ade87	2026-01-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218830 application number: ANDA218830 ndc (package): 67046-1652-3 ndc (product): 67046-1652 ndc11 (package): 67046165203
methimazole	METHIMAZOLE	Viona Pharmaceuticals Inc.	05a8fed7-f805-4c59-8840-630174b6d130	2025-09-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218830 application number: ANDA218830
methimazole	METHIMAZOLE	SQUARE PHARMACEUTICALS PLC.	33e065a1-dd4e-43f9-a841-f96e633fc850	2024-02-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218830 application number: ANDA218830

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	490f168f-c703-5497-e063-6294a90ade87	1
197941	methimazole 10 MG Oral Tablet	SCD	490f168f-c703-5497-e063-6294a90ade87	1
197941	thiamazole 10 MG Oral Tablet	SY	490f168f-c703-5497-e063-6294a90ade87	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
67046-1652-3	67046165203	30 TABLET in 1 BLISTER PACK (67046-1652-3)	30 tablet	2026-01-23	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Methimazole Tablets, USP Rx only	Coupler LLC \| SQUARE PHARMACEUTICALS PLC.	2026-01-23	HUMAN PRESCRIPTION DRUG LABEL	1