Methimazole

Product NDC
71335-2349
11-digit product format
713352349
Labeler code
71335
Product ID
71335-2349_800b68d3-b7df-4232-9de2-a9631b85713d
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
10 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
METHIMAZOLE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii554Z48XN5E
Rxcui197941

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
71335-2349-1Methimazole30 in 1 BOTTLETABLET30100
71335-2349-2Methimazole15 in 1 BOTTLETABLET15100
71335-2349-3Methimazole90 in 1 BOTTLETABLET90100

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2349METHIMAZOLE TABLET [BRYANT RANCH PREPACK]100Current NDC, 3 package rows20240223_e03d32dd-878f-43ee-b8c2-3adad98bf66c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197941methIMAzole 10 MG Oral TabletPSNe03d32dd-878f-43ee-b8c2-3adad98bf66c100
197941methimazole 10 MG Oral TabletSCDe03d32dd-878f-43ee-b8c2-3adad98bf66c100
197941thiamazole 10 MG Oral TabletSYe03d32dd-878f-43ee-b8c2-3adad98bf66c100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2349-17133523490130 TABLET in 1 BOTTLE (71335-2349-1) 30 tablet2024-02-21NoNoCurrent
71335-2349-27133523490215 TABLET in 1 BOTTLE (71335-2349-2) 15 tablet2024-02-21NoNoCurrent
71335-2349-37133523490390 TABLET in 1 BOTTLE (71335-2349-3) 90 tablet2024-02-21NoNoCurrent