methimazole

Product NDC
67046-1651
11-digit product format
670461651
Labeler code
67046
Product ID
67046-1651_490f045d-bcd2-3eb2-e063-6294a90a6d59
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
methimazole
Dosage form
TABLET
Route
ORAL
Labeler
Coupler LLC
Application
ANDA218830
Marketing category
ANDA
Marketing start
2026-01-23
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
methimazole
Listing expiration
2027-12-31

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
67046-1651-3methimazole30 in 1 BLISTER PACKTABLET301

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197942methIMAzole 5 MG Oral TabletPSN490f04db-cb51-bde7-e063-6394a90a55461
197942methimazole 5 MG Oral TabletSCD490f04db-cb51-bde7-e063-6394a90a55461
197942thiamazole 5 MG Oral TabletSY490f04db-cb51-bde7-e063-6394a90a55461

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
67046-1651-36704616510330 TABLET in 1 BLISTER PACK (67046-1651-3) 30 tablet2026-01-23NoNoHistorical