Methimazole

Product NDC
63629-8347
11-digit product format
636298347
Labeler code
63629
Product ID
63629-8347_ab0124b1-3769-400f-8544-398aaa689615
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methimazole
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
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

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 Identifiers#

Field, Values table
FieldValues
Unii554Z48XN5E
Rxcui197942

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
63629-8347-1Methimazole30 in 1 BOTTLETABLET303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8347METHIMAZOLE TABLET [BRYANT RANCH PREPACK]3Current NDC, Legacy NDC, 1 package rows20231109_3ca961ca-cbf2-4a73-8c81-4205e01b2695.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-8347-16362983470130 TABLET in 1 BOTTLE (63629-8347-1) 30 tablet2020-09-010000-00-00NoNoCurrent