Methimazole

Product NDC
49884-640
Requested package NDC
49884-640-05
11-digit product format
498840640
Labeler code
49884
Product ID
49884-640_c6608bc7-3b0c-4760-a7a1-bcc5c200685d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
methimazole
Dosage form
TABLET
Route
ORAL
Labeler
Par Pharmaceutical, Inc.
Application
ANDA040350
Marketing category
ANDA
Marketing start
2000-03-29
Marketing end
2024-10-31
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
0000-00-00
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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage49884-64049884-640-05DDiscontinued by firm2026-08-11

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 · 10 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…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040350-001METHIMAZOLEMETHIMAZOLE5MGTABLET / ORALAB2000-03-29
A040350-002METHIMAZOLEMETHIMAZOLE10MGTABLET / ORALABRS2000-03-29
A040350-003METHIMAZOLEMETHIMAZOLE20MGTABLET / ORAL2001-06-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A040350-001AB
A040350-002AB

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 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A040350-001METHIMAZOLE5MGTABLET / ORALAB2000-03-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040350-002METHIMAZOLE10MGTABLET / ORALABRS2000-03-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040350-003METHIMAZOLE20MGTABLET / ORAL2001-06-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040350-001METHIMAZOLE5MGTABLET / ORALAB2000-03-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040350-002METHIMAZOLE10MGTABLET / ORALABRS2000-03-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040350-003METHIMAZOLE20MGTABLET / ORAL2001-06-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A040350-001METHIMAZOLE5MGTABLET / ORALAB2000-03-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040350-002METHIMAZOLE10MGTABLET / ORALABRS2000-03-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040350-003METHIMAZOLE20MGTABLET / ORAL2001-06-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040350-001METHIMAZOLE5MGTABLET / ORALAB2000-03-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040350-002METHIMAZOLE10MGTABLET / ORALABRS2000-03-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040350-003METHIMAZOLE20MGTABLET / ORAL2001-06-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040350-001METHIMAZOLE5MGTABLET / ORALAB2000-03-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040350-002METHIMAZOLE10MGTABLET / ORALABRS2000-03-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040350-003METHIMAZOLE20MGTABLET / ORAL2001-06-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040350-001METHIMAZOLE5MGTABLET / ORALAB2000-03-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040350-002METHIMAZOLE10MGTABLET / ORALABRS2000-03-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040350-003METHIMAZOLE20MGTABLET / ORAL2001-06-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040350-001METHIMAZOLE5MGTABLET / ORALAB2000-03-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040350-002METHIMAZOLE10MGTABLET / ORALABRS2000-03-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040350-003METHIMAZOLE20MGTABLET / ORAL2001-06-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040350-001METHIMAZOLE5MGTABLET / ORALAB2000-03-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040350-002METHIMAZOLE10MGTABLET / ORALABRS2000-03-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040350-003METHIMAZOLE20MGTABLET / ORAL2001-06-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040350-001METHIMAZOLE5MGTABLET / ORALAB2000-03-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040350-002METHIMAZOLE10MGTABLET / ORALABRS2000-03-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040350-003METHIMAZOLE20MGTABLET / ORAL2001-06-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040350-001METHIMAZOLE5MGTABLET / ORALAB2000-03-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A040350-002METHIMAZOLE10MGTABLET / ORALABRS2000-03-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A040350-003METHIMAZOLE20MGTABLET / ORAL2001-06-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040350-001METHIMAZOLE5MGTABLET / ORALAB2000-03-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040350-002METHIMAZOLE10MGTABLET / ORALABRS2000-03-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040350-003METHIMAZOLE20MGTABLET / ORAL2001-06-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040350-001METHIMAZOLE5MGTABLET / ORALAB2000-03-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040350-002METHIMAZOLE10MGTABLET / ORALABRS2000-03-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040350-003METHIMAZOLE20MGTABLET / ORAL2001-06-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040350-001METHIMAZOLE5MGTABLET / ORALAB2000-03-291e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040350-002METHIMAZOLE10MGTABLET / ORALABRS2000-03-291e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040350-003METHIMAZOLE20MGTABLET / ORAL2001-06-071e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040350-001METHIMAZOLE5MGTABLET / ORALAB2000-03-298072bd15b7f6…

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 UTC2026-02A040350-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040350-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040350-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040350-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040350-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040350-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040350-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040350-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040350-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040350-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040350-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040350-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040350-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040350-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040350-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040350-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040350-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040350-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040350-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A040350-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040350-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040350-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040350-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040350-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040350-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040350-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040350-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A040350-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040350-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040350-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040350-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A040350-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040350-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A040350-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040350-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A040350-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040350-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A040350-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040350-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A040350-002AB1782e0a99824c…

DailyMed Product Concepts#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49884-640-01EA - Each49884-6403bb2216a-4042-40cf-85a2-4283a278820a12012-07-24
49884-640-05EA - Each49884-640277bd27c-62eb-405e-9b8b-e6974a6de8f512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METHIMAZOLEACTIVE INGREDIENT554Z48XN5EMETHIMAZOLE TABLET [PHYSICIANS TOTAL CARE, INC.]4
METHIMAZOLEACTIVE MOIETY554Z48XN5EMETHIMAZOLE TABLET [PHYSICIANS TOTAL CARE, INC.]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMETHIMAZOLE TABLET [PHYSICIANS TOTAL CARE, INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METHIMAZOLE TABLET [PHYSICIANS TOTAL CARE, INC.]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMETHIMAZOLE TABLET [PHYSICIANS TOTAL CARE, INC.]4
TALCINACTIVE INGREDIENT7SEV7J4R1UMETHIMAZOLE TABLET [PHYSICIANS TOTAL CARE, INC.]4
METHIMAZOLEACTIVE INGREDIENT554Z48XN5EMETHIMAZOLE TABLET [PAR PHARMACEUTICAL INC]3
METHIMAZOLEACTIVE MOIETY554Z48XN5EMETHIMAZOLE TABLET [PAR PHARMACEUTICAL INC]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMETHIMAZOLE TABLET [PAR PHARMACEUTICAL INC]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METHIMAZOLE TABLET [PAR PHARMACEUTICAL INC]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMETHIMAZOLE TABLET [PAR PHARMACEUTICAL INC]3
TALCINACTIVE INGREDIENT7SEV7J4R1UMETHIMAZOLE TABLET [PAR PHARMACEUTICAL INC]3
METHIMAZOLEACTIVE INGREDIENT554Z48XN5EMETHIMAZOLE TABLET [REBEL DISTRIBUTORS CORP.]1
METHIMAZOLEACTIVE MOIETY554Z48XN5EMETHIMAZOLE TABLET [REBEL DISTRIBUTORS CORP.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMETHIMAZOLE TABLET [REBEL DISTRIBUTORS CORP.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METHIMAZOLE TABLET [REBEL DISTRIBUTORS CORP.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMETHIMAZOLE TABLET [REBEL DISTRIBUTORS CORP.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UMETHIMAZOLE TABLET [REBEL DISTRIBUTORS CORP.]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 · 12 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MethimazoleMETHIMAZOLEBryant Ranch Prepackafa2cecc-3fef-4372-8d1e-6bbb06d41b232025-12-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040350
application number: ANDA040350
MethimazoleMETHIMAZOLEBryant Ranch Prepack3f65518b-33da-48d8-9af2-2a750400b4012025-12-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040350
application number: ANDA040350
MethimazoleMETHIMAZOLEBryant Ranch Prepackd05f7950-84cd-413f-9256-4c0977818d252025-11-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040350
application number: ANDA040350
MethimazoleMETHIMAZOLEBryant Ranch Prepack1f6970fb-a549-47b0-b812-48109521d7132025-11-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040350
application number: ANDA040350
MethimazoleMETHIMAZOLEBryant Ranch Prepack94d2e57b-685f-4cfd-a5a5-129e869c794c2025-04-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040350
application number: ANDA040350
MethimazoleMETHIMAZOLEBryant Ranch Prepacka86f51a6-1ab8-48c2-a4fc-2439e9986d452025-04-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040350
application number: ANDA040350
MethimazoleMETHIMAZOLEAmerican Health Packagingca252851-32f2-4eb9-b9f5-82029f0e8c202024-12-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040350
application number: ANDA040350
MethimazoleMETHIMAZOLEBryant Ranch Prepackd003a93d-da08-4993-bb72-700342ca6e652024-12-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040350
application number: ANDA040350
MethimazoleMETHIMAZOLEBryant Ranch Prepacke03d32dd-878f-43ee-b8c2-3adad98bf66c2024-02-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040350
application number: ANDA040350
MethimazoleMETHIMAZOLEBryant Ranch Prepackc511344b-cc7f-499b-bb21-5b2312ff311e2023-02-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040350
application number: ANDA040350
MethimazoleMETHIMAZOLEBryant Ranch Prepack6bdf42f6-0ce6-4e05-8962-0019fc7c65a22023-02-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040350
application number: ANDA040350
MethimazoleMETHIMAZOLEStrides Pharma Science Limited0f5fb0a4-feb9-4b86-9a93-b2c84cfc082f2022-04-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040350
application number: ANDA040350

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197942methIMAzole 5 MG Oral TabletPSN54e30401-7ad3-464b-9aa5-8e4a6527893b7
197942methimazole 5 MG Oral TabletSCD54e30401-7ad3-464b-9aa5-8e4a6527893b7
197942thiamazole 5 MG Oral TabletSY54e30401-7ad3-464b-9aa5-8e4a6527893b7
197941methIMAzole 10 MG Oral TabletPSN4d42cebc-5d3e-4b88-883f-5875b83a55154
197942methIMAzole 5 MG Oral TabletPSN4d42cebc-5d3e-4b88-883f-5875b83a55154
197941methimazole 10 MG Oral TabletSCD4d42cebc-5d3e-4b88-883f-5875b83a55154
197942methimazole 5 MG Oral TabletSCD4d42cebc-5d3e-4b88-883f-5875b83a55154
197941thiamazole 10 MG Oral TabletSY4d42cebc-5d3e-4b88-883f-5875b83a55154
197942thiamazole 5 MG Oral TabletSY4d42cebc-5d3e-4b88-883f-5875b83a55154
197941methIMAzole 10 MG Oral TabletPSN74238d87-5f82-4a5e-a920-a9fc68115e911
197942methIMAzole 5 MG Oral TabletPSN74238d87-5f82-4a5e-a920-a9fc68115e911
197941methimazole 10 MG Oral TabletSCD74238d87-5f82-4a5e-a920-a9fc68115e911
197942methimazole 5 MG Oral TabletSCD74238d87-5f82-4a5e-a920-a9fc68115e911
197941thiamazole 10 MG Oral TabletSY74238d87-5f82-4a5e-a920-a9fc68115e911
197942thiamazole 5 MG Oral TabletSY74238d87-5f82-4a5e-a920-a9fc68115e911

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49884-640-0549884064005500 TABLET in 1 BOTTLE (49884-640-05) 500 tablet2000-04-132024-10-31NoNoCurrent