Methimazole

Product NDC
68788-8226
11-digit product format
687888226
Labeler code
68788
Product ID
68788-8226_8151209d-8832-4a7b-8b4c-cc32c62ffeea
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methimazole
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA040734
Marketing category
ANDA
Marketing start
2022-08-08
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

Additional Listing Data#

Finished product
Yes
Brand name base
Methimazole
Listing expiration
2026-12-31

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
68788-8226-3Methimazole30 in 1 BOTTLETABLET304
68788-8226-6Methimazole60 in 1 BOTTLETABLET604

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8226-3EA - Each68788-8226b45e2cd8-b233-4ff2-a40b-e402d8ca115112022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8226METHIMAZOLE TABLET [PREFERRED PHARMACEUTICALS INC.]3Current NDC, Legacy NDC, 2 package rows20240712_c1e6f1ee-238c-466e-b223-3c3f63dac9ed.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197942methIMAzole 5 MG Oral TabletPSNc1e6f1ee-238c-466e-b223-3c3f63dac9ed4
197942methimazole 5 MG Oral TabletSCDc1e6f1ee-238c-466e-b223-3c3f63dac9ed4
197942thiamazole 5 MG Oral TabletSYc1e6f1ee-238c-466e-b223-3c3f63dac9ed4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-8226-36878882260330 TABLET in 1 BOTTLE (68788-8226-3) 30 tablet2022-08-080000-00-00NoNoCurrent
68788-8226-66878882260660 TABLET in 1 BOTTLE (68788-8226-6) 60 tablet2022-08-080000-00-00NoNoCurrent