Methimazole

Product NDC
64380-212
11-digit product format
643800212
Labeler code
64380
Product ID
64380-212_e355c721-78d1-4a61-96db-77df6c5b41ed
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
methimazole
Dosage form
TABLET
Route
ORAL
Labeler
Strides Pharma Science Limited
Application
ANDA040350
Marketing category
ANDA
Marketing start
2022-03-14
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 · 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…

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
0f5fb0a4-feb9-4b86-9a93-b2c84cfc082fAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
42f09d00-d445-e29e-bea8-dfb46b9366fcProduct name420251118
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64380-212-01Methimazole100 in 1 BOTTLETABLET1004
64380-212-02Methimazole500 in 1 BOTTLETABLET5004
64380-212-03Methimazole1000 in 1 BOTTLETABLET10004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64380-212-01EA - Each64380-21288c5c594-4c62-45aa-8514-9d42e52685cd12022-04-06
64380-212-02EA - Each64380-212e0440139-f160-43fd-b301-23cde04c70b812022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64380-212METHIMAZOLE TABLET [STRIDES PHARMA SCIENCE LIMITED]4Current NDC, Legacy NDC, 3 package rows20220423_0f5fb0a4-feb9-4b86-9a93-b2c84cfc082f.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 · 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
ndc (product): 64380-212

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197942methIMAzole 5 MG Oral TabletPSN94d2e57b-685f-4cfd-a5a5-129e869c794c107
197942methimazole 5 MG Oral TabletSCD94d2e57b-685f-4cfd-a5a5-129e869c794c107
197942thiamazole 5 MG Oral TabletSY94d2e57b-685f-4cfd-a5a5-129e869c794c107
197942methIMAzole 5 MG Oral TabletPSN6bdf42f6-0ce6-4e05-8962-0019fc7c65a2104
197942methimazole 5 MG Oral TabletSCD6bdf42f6-0ce6-4e05-8962-0019fc7c65a2104
197942thiamazole 5 MG Oral TabletSY6bdf42f6-0ce6-4e05-8962-0019fc7c65a2104
197942methIMAzole 5 MG Oral TabletPSNc511344b-cc7f-499b-bb21-5b2312ff311e102
197942methimazole 5 MG Oral TabletSCDc511344b-cc7f-499b-bb21-5b2312ff311e102
197942thiamazole 5 MG Oral TabletSYc511344b-cc7f-499b-bb21-5b2312ff311e102
197942methIMAzole 5 MG Oral TabletPSNd05f7950-84cd-413f-9256-4c0977818d25100
197942methIMAzole 5 MG Oral TabletPSNafa2cecc-3fef-4372-8d1e-6bbb06d41b23100
197942methimazole 5 MG Oral TabletSCDd05f7950-84cd-413f-9256-4c0977818d25100
197942methimazole 5 MG Oral TabletSCDafa2cecc-3fef-4372-8d1e-6bbb06d41b23100
197942thiamazole 5 MG Oral TabletSYafa2cecc-3fef-4372-8d1e-6bbb06d41b23100
197942thiamazole 5 MG Oral TabletSYd05f7950-84cd-413f-9256-4c0977818d25100
197941methIMAzole 10 MG Oral TabletPSNca252851-32f2-4eb9-b9f5-82029f0e8c205
197942methIMAzole 5 MG Oral TabletPSNca252851-32f2-4eb9-b9f5-82029f0e8c205
197941methimazole 10 MG Oral TabletSCDca252851-32f2-4eb9-b9f5-82029f0e8c205
197942methimazole 5 MG Oral TabletSCDca252851-32f2-4eb9-b9f5-82029f0e8c205
197941thiamazole 10 MG Oral TabletSYca252851-32f2-4eb9-b9f5-82029f0e8c205
197942thiamazole 5 MG Oral TabletSYca252851-32f2-4eb9-b9f5-82029f0e8c205
197941methIMAzole 10 MG Oral TabletPSN0f5fb0a4-feb9-4b86-9a93-b2c84cfc082f4
197942methIMAzole 5 MG Oral TabletPSN0f5fb0a4-feb9-4b86-9a93-b2c84cfc082f4
197941methimazole 10 MG Oral TabletSCD0f5fb0a4-feb9-4b86-9a93-b2c84cfc082f4
197942methimazole 5 MG Oral TabletSCD0f5fb0a4-feb9-4b86-9a93-b2c84cfc082f4
197941thiamazole 10 MG Oral TabletSY0f5fb0a4-feb9-4b86-9a93-b2c84cfc082f4
197942thiamazole 5 MG Oral TabletSY0f5fb0a4-feb9-4b86-9a93-b2c84cfc082f4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64380-212-0164380021201100 TABLET in 1 BOTTLE (64380-212-01) 100 tablet2022-03-140000-00-00NoNoCurrent
64380-212-0264380021202500 TABLET in 1 BOTTLE (64380-212-02) 500 tablet2022-03-140000-00-00NoNoCurrent
64380-212-03643800212031000 TABLET in 1 BOTTLE (64380-212-03) 1000 tablet2024-02-28NoNoCurrent