Methimazole

Product NDC: 51293-820
Requested package NDC: 51293-820-01
11-digit product format: 512930820
Labeler code: 51293
Product ID: 51293-820_f141938a-ce0d-4e93-bb2c-53c2461e1d67
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Methimazole
Dosage form: TABLET
Route: ORAL
Labeler: ECI Pharmaceuticals, LLC
Application: ANDA040547
Marketing category: ANDA
Marketing start: 2016-07-01
Marketing end: 0000-00-00
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: 2021-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	51293-820	51293-820-01	D	Discontinued by firm		2026-08-11

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 · 18 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	`bd6a592717d7…`	`303034d00443…`

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	Approval date
A040547-001	METHIMAZOLE	METHIMAZOLE	5MG	TABLET / ORAL	AB	2005-02-18
A040547-002	METHIMAZOLE	METHIMAZOLE	10MG	TABLET / ORAL	AB	2005-02-18
A040547-004	METHIMAZOLE	METHIMAZOLE	20MG	TABLET / ORAL		2005-02-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040547-001	AB
A040547-002	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A040547-001	METHIMAZOLE	5MG	TABLET / ORAL	AB	2005-02-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040547-002	METHIMAZOLE	10MG	TABLET / ORAL	AB	2005-02-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040547-004	METHIMAZOLE	20MG	TABLET / ORAL		2005-02-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040547-001	METHIMAZOLE	5MG	TABLET / ORAL	AB	2005-02-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040547-002	METHIMAZOLE	10MG	TABLET / ORAL	AB	2005-02-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040547-004	METHIMAZOLE	20MG	TABLET / ORAL		2005-02-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040547-001	METHIMAZOLE	5MG	TABLET / ORAL	AB	2005-02-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040547-002	METHIMAZOLE	10MG	TABLET / ORAL	AB	2005-02-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040547-004	METHIMAZOLE	20MG	TABLET / ORAL		2005-02-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040547-001	METHIMAZOLE	5MG	TABLET / ORAL	AB	2005-02-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040547-002	METHIMAZOLE	10MG	TABLET / ORAL	AB	2005-02-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040547-004	METHIMAZOLE	20MG	TABLET / ORAL		2005-02-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040547-001	METHIMAZOLE	5MG	TABLET / ORAL	AB	2005-02-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040547-002	METHIMAZOLE	10MG	TABLET / ORAL	AB	2005-02-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040547-004	METHIMAZOLE	20MG	TABLET / ORAL		2005-02-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040547-001	METHIMAZOLE	5MG	TABLET / ORAL	AB	2005-02-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040547-002	METHIMAZOLE	10MG	TABLET / ORAL	AB	2005-02-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040547-004	METHIMAZOLE	20MG	TABLET / ORAL		2005-02-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040547-001	METHIMAZOLE	5MG	TABLET / ORAL	AB	2005-02-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040547-002	METHIMAZOLE	10MG	TABLET / ORAL	AB	2005-02-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040547-004	METHIMAZOLE	20MG	TABLET / ORAL		2005-02-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040547-001	METHIMAZOLE	5MG	TABLET / ORAL	AB	2005-02-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040547-002	METHIMAZOLE	10MG	TABLET / ORAL	AB	2005-02-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040547-004	METHIMAZOLE	20MG	TABLET / ORAL		2005-02-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040547-001	METHIMAZOLE	5MG	TABLET / ORAL	AB	2005-02-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040547-002	METHIMAZOLE	10MG	TABLET / ORAL	AB	2005-02-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040547-004	METHIMAZOLE	20MG	TABLET / ORAL		2005-02-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040547-001	METHIMAZOLE	5MG	TABLET / ORAL	AB	2005-02-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040547-002	METHIMAZOLE	10MG	TABLET / ORAL	AB	2005-02-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040547-004	METHIMAZOLE	20MG	TABLET / ORAL		2005-02-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040547-001	METHIMAZOLE	5MG	TABLET / ORAL	AB	2005-02-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040547-002	METHIMAZOLE	10MG	TABLET / ORAL	AB	2005-02-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040547-004	METHIMAZOLE	20MG	TABLET / ORAL		2005-02-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040547-001	METHIMAZOLE	5MG	TABLET / ORAL	AB	2005-02-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040547-002	METHIMAZOLE	10MG	TABLET / ORAL	AB	2005-02-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040547-004	METHIMAZOLE	20MG	TABLET / ORAL		2005-02-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040547-001	METHIMAZOLE	5MG	TABLET / ORAL	AB	2005-02-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040547-002	METHIMAZOLE	10MG	TABLET / ORAL	AB	2005-02-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040547-004	METHIMAZOLE	20MG	TABLET / ORAL		2005-02-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040547-001	METHIMAZOLE	5MG	TABLET / ORAL	AB	2005-02-18	`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	A040547-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040547-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040547-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040547-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040547-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040547-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040547-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040547-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040547-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040547-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040547-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040547-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040547-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040547-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040547-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040547-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040547-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040547-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040547-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040547-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040547-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040547-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040547-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040547-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040547-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040547-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040547-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040547-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040547-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040547-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040547-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040547-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040547-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040547-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040547-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040547-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040547-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040547-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040547-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A040547-002	AB	1	`782e0a99824c…`

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
51293-820-01	2026-01-22	C162847	48780-1	d6a99b39-9b36-a426-e053-dadaa90af4c2	METHIMAZOLE TABLETS, USP
51293-820-01	2022-01-28	C162847	48780-1	d6a99b39-9b36-a426-e053-dadaa90af4c2	METHIMAZOLE TABLETS, USP

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51293-820-01	EA - Each	51293-820	cd7d47d5-16a1-45d2-995c-5a03269539e0	1	2017-06-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51293-820	METHIMAZOLE TABLET [ECI PHARMACEUTICALS, LLC]	5	Legacy NDC	20201228_68942ec1-763a-4757-96ad-0e749aba348c.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Methimazole	METHIMAZOLE	AvKARE	545381b6-e9e9-de1e-e063-6294a90a9a97	2026-06-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040547 application number: ANDA040547
Methimazole	METHIMAZOLE	AiPing Pharmaceutical, Inc.	06bb4bcc-5e47-48b6-a76c-648f846704e8	2026-02-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040547 application number: ANDA040547
Methimazole	METHIMAZOLE	Upsher-Smith Laboratories, LLC	2185e6e0-7c21-4348-a7b4-d898f50a0184	2024-03-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040547 application number: ANDA040547

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	acae35a6-dea2-3fa9-e053-2a95a90a3a4d	1
197942	methimazole 5 MG Oral Tablet	SCD	acae35a6-dea2-3fa9-e053-2a95a90a3a4d	1
197942	thiamazole 5 MG Oral Tablet	SY	acae35a6-dea2-3fa9-e053-2a95a90a3a4d	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51293-820-01	51293082001	100 TABLET in 1 BOTTLE (51293-820-01)	100 tablet	2016-07-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
METHIMAZOLE TABLETS, USP	Bryant Ranch Prepack	2021-02-01	HUMAN PRESCRIPTION DRUG LABEL	100
METHIMAZOLE TABLETS, USP	ECI Pharmaceuticals, LLC	2020-12-27	HUMAN PRESCRIPTION DRUG LABEL	5
METHIMAZOLE TABLETS, USP	Denton Pharma, Inc. dba Northwind Pharmaceuticals	2020-03-19	HUMAN PRESCRIPTION DRUG LABEL	1