Methimazole

Product NDC
60429-381
11-digit product format
604290381
Labeler code
60429
Product ID
60429-381_22e3d28a-6a11-3011-e063-6394a90a3434
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methimazole
Dosage form
TABLET
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA040734
Marketing category
ANDA
Marketing start
2007-12-14
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

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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage60429-38160429-381-10DDiscontinued by firm2026-08-03

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040734-001METHIMAZOLEMETHIMAZOLE5MGTABLET / ORALAB2007-12-14
A040734-002METHIMAZOLEMETHIMAZOLE10MGTABLET / ORALAB2007-12-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A040734-001AB
A040734-002AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A040734-001METHIMAZOLE5MGTABLET / ORALAB2007-12-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040734-002METHIMAZOLE10MGTABLET / ORALAB2007-12-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040734-001METHIMAZOLE5MGTABLET / ORALAB2007-12-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040734-002METHIMAZOLE10MGTABLET / ORALAB2007-12-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08A040734-001METHIMAZOLE5MGTABLET / ORALAB2007-12-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040734-002METHIMAZOLE10MGTABLET / ORALAB2007-12-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040734-001METHIMAZOLE5MGTABLET / ORALAB2007-12-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040734-002METHIMAZOLE10MGTABLET / ORALAB2007-12-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040734-001METHIMAZOLE5MGTABLET / ORALAB2007-12-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040734-002METHIMAZOLE10MGTABLET / ORALAB2007-12-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040734-001METHIMAZOLE5MGTABLET / ORALAB2007-12-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040734-002METHIMAZOLE10MGTABLET / ORALAB2007-12-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040734-001METHIMAZOLE5MGTABLET / ORALAB2007-12-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040734-002METHIMAZOLE10MGTABLET / ORALAB2007-12-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040734-001METHIMAZOLE5MGTABLET / ORALAB2007-12-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040734-002METHIMAZOLE10MGTABLET / ORALAB2007-12-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040734-001METHIMAZOLE5MGTABLET / ORALAB2007-12-14d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040734-002METHIMAZOLE10MGTABLET / ORALAB2007-12-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040734-001METHIMAZOLE5MGTABLET / ORALAB2007-12-14d06236e962d9…
2024-10-29 15:01 UTC2024-10A040734-002METHIMAZOLE10MGTABLET / ORALAB2007-12-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040734-001METHIMAZOLE5MGTABLET / ORALAB2007-12-1479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040734-002METHIMAZOLE10MGTABLET / ORALAB2007-12-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040734-001METHIMAZOLE5MGTABLET / ORALAB2007-12-14301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040734-002METHIMAZOLE10MGTABLET / ORALAB2007-12-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040734-001METHIMAZOLE5MGTABLET / ORALAB2007-12-141e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040734-002METHIMAZOLE10MGTABLET / ORALAB2007-12-141e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040734-001METHIMAZOLE5MGTABLET / ORALAB2007-12-148072bd15b7f6…
2024-05-31 18:47 UTC2024-05A040734-002METHIMAZOLE10MGTABLET / ORALAB2007-12-148072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040734-001METHIMAZOLE5MGTABLET / ORALAB2007-12-145c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040734-002METHIMAZOLE10MGTABLET / ORALAB2007-12-145c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040734-001METHIMAZOLE5MGTABLET / ORALAB2007-12-145d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A040734-002METHIMAZOLE10MGTABLET / ORALAB2007-12-145d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040734-001METHIMAZOLE5MGTABLET / ORALAB2007-12-144b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A040734-002METHIMAZOLE10MGTABLET / ORALAB2007-12-144b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040734-001METHIMAZOLE5MGTABLET / ORALAB2007-12-1474a2ff9319b5…
2019-12-13 00:20 UTC2019-12A040734-002METHIMAZOLE10MGTABLET / ORALAB2007-12-1474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040734-001METHIMAZOLE5MGTABLET / ORALAB2007-12-14bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A040734-002METHIMAZOLE10MGTABLET / ORALAB2007-12-14bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040734-001METHIMAZOLE5MGTABLET / ORALAB2007-12-14782e0a99824c…
2021-12-28 21:50 UTC2021-12A040734-002METHIMAZOLE10MGTABLET / ORALAB2007-12-14782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A040734-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040734-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040734-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040734-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040734-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040734-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040734-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040734-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040734-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040734-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040734-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040734-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040734-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040734-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040734-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040734-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040734-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040734-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040734-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A040734-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040734-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040734-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040734-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040734-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040734-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040734-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040734-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A040734-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040734-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040734-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040734-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A040734-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040734-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A040734-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040734-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A040734-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040734-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A040734-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040734-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A040734-002AB1782e0a99824c…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHIMAZOLE10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
554Z48XN5EInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197941Internal RxNorm lookup
197942Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4eff3321-2fce-4bab-94af-7b16e333beedAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
42f09d00-d445-e29e-bea8-dfb46b9366fcProduct name420251118

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60429-381-01Methimazole100 in 1 BOTTLETABLET1009
60429-381-10Methimazole1000 in 1 BOTTLETABLET10009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60429-381-01EA - Each60429-38182e4a7e8-efba-410c-b75f-c047eb6617dd12013-07-02
60429-381-10EA - Each60429-38173ec1f8d-72c8-4354-b386-c35c7a23ce6812020-04-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METHIMAZOLEACTIVE INGREDIENT554Z48XN5EMETHIMAZOLE TABLET [GOLDEN STATE MEDICAL SUPPLY INC.]2
METHIMAZOLEACTIVE MOIETY554Z48XN5EMETHIMAZOLE TABLET [GOLDEN STATE MEDICAL SUPPLY INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMETHIMAZOLE TABLET [GOLDEN STATE MEDICAL SUPPLY INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METHIMAZOLE TABLET [GOLDEN STATE MEDICAL SUPPLY INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMETHIMAZOLE TABLET [GOLDEN STATE MEDICAL SUPPLY INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1UMETHIMAZOLE TABLET [GOLDEN STATE MEDICAL SUPPLY INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60429-381METHIMAZOLE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]9Current NDC, Legacy NDC, 2 package rows20240926_4eff3321-2fce-4bab-94af-7b16e333beed.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MethimazoleMETHIMAZOLEREMEDYREPACK INC.b53f84ac-4263-478c-883d-aca7ab44fef52026-07-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040734
application number: ANDA040734
MethimazoleMETHIMAZOLEREMEDYREPACK INC.2c6a9c70-4ed6-4f05-bc3d-e8e7aca57c2b2026-07-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040734
application number: ANDA040734
MethimazoleMETHIMAZOLEPreferred Pharmaceuticals Inc.c1e6f1ee-238c-466e-b223-3c3f63dac9ed2026-06-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040734
application number: ANDA040734
MethimazoleMETHIMAZOLEPreferred Pharmaceuticals Inc.244d76f1-98e6-4305-8768-b104f6a4be072026-06-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040734
application number: ANDA040734
MethimazoleMETHIMAZOLEProficient Rx LPe921f23b-a9bf-4313-9cfa-f0b29c06f72a2025-07-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040734
application number: ANDA040734
MethimazoleMETHIMAZOLEGolden State Medical Supply, Inc.4eff3321-2fce-4bab-94af-7b16e333beed2024-09-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040734
application number: ANDA040734
ndc (product): 60429-381
MethimazoleMETHIMAZOLENORTHSTAR RX LLC923fec30-90fd-4bd5-beb3-f2ca4fc171ee2024-06-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040734
application number: ANDA040734
MethimazoleMETHIMAZOLEBryant Ranch Prepack381052c4-891c-4ae4-b63e-65229126cbca2023-11-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040734
application number: ANDA040734
MethimazoleMETHIMAZOLEBryant Ranch Prepack3ca961ca-cbf2-4a73-8c81-4205e01b26952023-11-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040734
application number: ANDA040734
MethimazoleMETHIMAZOLEA-S Medication Solutions87eb663e-5dd3-4a7a-8b28-7e19c5ad11732023-06-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040734
application number: ANDA040734
MethimazoleMETHIMAZOLEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.8c3a9aaa-cdde-404b-9af6-5a88ef649aac2022-03-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040734
application number: ANDA040734

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197941methIMAzole 10 MG Oral TabletPSN4eff3321-2fce-4bab-94af-7b16e333beed9
197942methIMAzole 5 MG Oral TabletPSN4eff3321-2fce-4bab-94af-7b16e333beed9
197941methimazole 10 MG Oral TabletSCD4eff3321-2fce-4bab-94af-7b16e333beed9
197942methimazole 5 MG Oral TabletSCD4eff3321-2fce-4bab-94af-7b16e333beed9
197941thiamazole 10 MG Oral TabletSY4eff3321-2fce-4bab-94af-7b16e333beed9
197942thiamazole 5 MG Oral TabletSY4eff3321-2fce-4bab-94af-7b16e333beed9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60429-381-0160429038101100 TABLET in 1 BOTTLE (60429-381-01) 100 tablet2013-05-310000-00-00NoNoCurrent
60429-381-10604290381101000 in 1 BOTTLEHistorical