Methimazole

Product NDC
63629-9250
11-digit product format
636299250
Labeler code
63629
Product ID
63629-9250_ec8b9cdd-da45-4afe-bbc2-7d10cc8c3e50
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
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
63629-9250-1Methimazole500 in 1 BOTTLETABLET500104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-9250-1EA - Each63629-925049bdb321-8dc5-41b8-accf-2d7904f63f5412022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-9250METHIMAZOLE TABLET [BRYANT RANCH PREPACK]104Current NDC, Legacy NDC, 1 package rows20230219_6bdf42f6-0ce6-4e05-8962-0019fc7c65a2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-9250-163629925001500 TABLET in 1 BOTTLE (63629-9250-1) 500 tablet2022-03-280000-00-00NoNoCurrent