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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
554Z48XN5EMETHIMAZOLE60-56-0METHIMAZOLE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
63629-9250-163629925001500 TABLET in 1 BOTTLE (63629-9250-1) 500 tablet2022-03-28NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Methimazole Tablets, USP Rx onlyBryant Ranch Prepack2023-02-17HUMAN PRESCRIPTION DRUG LABEL104