Methimazole

Product NDC
23155-070
11-digit product format
231550070
Labeler code
23155
Product ID
23155-070_649d3946-dc8c-4319-814f-a991d417d380
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methimazole
Dosage form
TABLET
Route
ORAL
Labeler
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application
ANDA040734
Marketing category
ANDA
Marketing start
2012-01-15
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 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
METHIMAZOLE5 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
8c3a9aaa-cdde-404b-9af6-5a88ef649aacAvailable 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
23155-070-01Methimazole100 in 1 BOTTLETABLET10010
23155-070-10Methimazole1000 in 1 BOTTLETABLET100010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23155-070-01EA - Each23155-070c18201ef-be1e-4f69-b322-ccf8a5984d3212012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23155-070METHIMAZOLE TABLET [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]10Current NDC, Legacy NDC, 2 package rows20220402_8c3a9aaa-cdde-404b-9af6-5a88ef649aac.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
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
ndc (product): 23155-070

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197942methIMAzole 5 MG Oral TabletPSNb53f84ac-4263-478c-883d-aca7ab44fef515
197942methimazole 5 MG Oral TabletSCDb53f84ac-4263-478c-883d-aca7ab44fef515
197942thiamazole 5 MG Oral TabletSYb53f84ac-4263-478c-883d-aca7ab44fef515
197941methIMAzole 10 MG Oral TabletPSN8c3a9aaa-cdde-404b-9af6-5a88ef649aac10
197942methIMAzole 5 MG Oral TabletPSN8c3a9aaa-cdde-404b-9af6-5a88ef649aac10
197941methimazole 10 MG Oral TabletSCD8c3a9aaa-cdde-404b-9af6-5a88ef649aac10
197942methimazole 5 MG Oral TabletSCD8c3a9aaa-cdde-404b-9af6-5a88ef649aac10
197941thiamazole 10 MG Oral TabletSY8c3a9aaa-cdde-404b-9af6-5a88ef649aac10
197942thiamazole 5 MG Oral TabletSY8c3a9aaa-cdde-404b-9af6-5a88ef649aac10
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
197942methIMAzole 5 MG Oral TabletPSNc1e6f1ee-238c-466e-b223-3c3f63dac9ed4
197942methimazole 5 MG Oral TabletSCDc1e6f1ee-238c-466e-b223-3c3f63dac9ed4
197942thiamazole 5 MG Oral TabletSYc1e6f1ee-238c-466e-b223-3c3f63dac9ed4
197942methIMAzole 5 MG Oral TabletPSN3ca961ca-cbf2-4a73-8c81-4205e01b26953
197942methimazole 5 MG Oral TabletSCD3ca961ca-cbf2-4a73-8c81-4205e01b26953
197942thiamazole 5 MG Oral TabletSY3ca961ca-cbf2-4a73-8c81-4205e01b26953
197942methIMAzole 5 MG Oral TabletPSN87eb663e-5dd3-4a7a-8b28-7e19c5ad11731
197942methimazole 5 MG Oral TabletSCD87eb663e-5dd3-4a7a-8b28-7e19c5ad11731
197942thiamazole 5 MG Oral TabletSY87eb663e-5dd3-4a7a-8b28-7e19c5ad11731

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
23155-070-0123155007001100 TABLET in 1 BOTTLE (23155-070-01) 100 tablet2012-01-150000-00-00NoNoCurrent
23155-070-10231550070101000 TABLET in 1 BOTTLE (23155-070-10) 1000 tablet2012-01-150000-00-00NoNoCurrent