Methimazole

Product NDC
63629-9251
11-digit product format
636299251
Labeler code
63629
Product ID
63629-9251_71cbfa1e-c9e0-4dc3-94fd-37f4b7b00e75
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
methimazole
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA040350
Marketing category
ANDA
Marketing start
2022-02-28
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

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 Identifiers#

Field, Values table
FieldValues
Unii554Z48XN5E
Rxcui197941

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
63629-9251-1Methimazole100 in 1 BOTTLETABLET100103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-9251-1EA - Each63629-925187e42a2d-e023-4c44-ba93-6fdfe32130a912022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-9251METHIMAZOLE TABLET [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 1 package rows20241226_d003a93d-da08-4993-bb72-700342ca6e65.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197941methIMAzole 10 MG Oral TabletPSNd003a93d-da08-4993-bb72-700342ca6e65103
197941methimazole 10 MG Oral TabletSCDd003a93d-da08-4993-bb72-700342ca6e65103
197941thiamazole 10 MG Oral TabletSYd003a93d-da08-4993-bb72-700342ca6e65103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-9251-163629925101100 TABLET in 1 BOTTLE (63629-9251-1) 100 tablet2022-03-280000-00-00NoNoCurrent