Methimazole

Product NDC
71335-2881
11-digit product format
713352881
Labeler code
71335
Product ID
71335-2881_bed689c9-83b6-4803-87fd-2e8eb8dff61b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
methimazole
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA040350
Marketing category
ANDA
Marketing start
2022-03-14
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

openFDA Listing Details

Product ID
71335-2881_bed689c9-83b6-4803-87fd-2e8eb8dff61b
SPL ID
bed689c9-83b6-4803-87fd-2e8eb8dff61b
Product type
HUMAN PRESCRIPTION DRUG
Finished product
Yes
Brand name base
Methimazole
Generic name
methimazole
Dosage form
TABLET
Route
ORAL
Marketing start
2022-03-14
Marketing category
ANDA
Application number
ANDA040350
Pharmacologic classes
Thyroid Hormone Synthesis Inhibitor [EPC]; Thyroid Hormone Synthesis Inhibitors [MoA]
Listing expiration
2026-12-31

openFDA Active Ingredients

IngredientStrength
METHIMAZOLE5 mg/1

openFDA Harmonized Identifiers

FieldValues
Unii554Z48XN5E
Rxcui197942
Spl Set Idd05f7950-84cd-413f-9256-4c0977818d25
Manufacturer NameBryant Ranch Prepack

openFDA Package Details

Package NDCDescriptionMarketing startSample
71335-2881-1100 TABLET in 1 BOTTLE (71335-2881-1)2025-11-06No

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
554Z48XN5EMETHIMAZOLE60-56-0METHIMAZOLE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2881-171335288101100 TABLET in 1 BOTTLE (71335-2881-1) 100 tablet2025-11-06NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Methimazole Tablets, USP Rx onlyBryant Ranch Prepack2025-11-06HUMAN PRESCRIPTION DRUG LABEL100