Methimazole

Product NDC
33342-336
11-digit product format
333420336
Labeler code
33342
Product ID
33342-336_ea518c56-49d7-4770-8ded-21e443e71c3c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methimazole
Dosage form
TABLET
Route
ORAL
Labeler
Macleods Pharmaceuticals Limited
Application
ANDA209827
Marketing category
ANDA
Marketing start
2023-05-24
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, 197942

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
33342-336-11Methimazole100 in 1 BOTTLETABLET1003
33342-336-12Methimazole10 in 1 CARTONTABLET103
33342-336-12Methimazole10 in 1 BLISTER PACKTABLET103
33342-336-44Methimazole1000 in 1 BOTTLETABLET10003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33342-336METHIMAZOLE TABLET [MACLEODS PHARMACEUTICALS LIMITED]2Current NDC, 4 package rows20230910_6f08df05-cc29-45ef-8f6e-12272bfbb0d7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197941methIMAzole 10 MG Oral TabletPSN6f08df05-cc29-45ef-8f6e-12272bfbb0d73
197942methIMAzole 5 MG Oral TabletPSN6f08df05-cc29-45ef-8f6e-12272bfbb0d73
197941methimazole 10 MG Oral TabletSCD6f08df05-cc29-45ef-8f6e-12272bfbb0d73
197942methimazole 5 MG Oral TabletSCD6f08df05-cc29-45ef-8f6e-12272bfbb0d73
197941thiamazole 10 MG Oral TabletSY6f08df05-cc29-45ef-8f6e-12272bfbb0d73
197942thiamazole 5 MG Oral TabletSY6f08df05-cc29-45ef-8f6e-12272bfbb0d73

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
33342-336-1133342033611100 TABLET in 1 BOTTLE (33342-336-11) 100 tablet2023-05-24NoNoCurrent
33342-336-123334203361210 BLISTER PACK in 1 CARTON (33342-336-12) / 10 TABLET in 1 BLISTER PACK10 blister pack2023-05-24NoNoCurrent
33342-336-44333420336441000 TABLET in 1 BOTTLE (33342-336-44) 1000 tablet2023-05-24NoNoCurrent