FDA.reportPublic FDA data

Methimazole

Product NDC
68788-8227
11-digit product format
687888227
Labeler code
68788
Product ID
68788-8227_19c1fbf3-81ac-4c90-b97c-e6bd07295622
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
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
68788-8227-1Methimazole100 in 1 BOTTLETABLET1004
68788-8227-3Methimazole30 in 1 BOTTLETABLET304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8227-1EA - Each68788-822767475df4-944a-4b0a-b3e8-4863588d1ae012022-09-12
68788-8227-3EA - Each68788-8227bd871e08-fc50-4ad4-84c0-b98982e3c73e12022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8227METHIMAZOLE TABLET [PREFERRED PHARMACEUTICALS INC.]3Current NDC, Legacy NDC, 2 package rows20240716_244d76f1-98e6-4305-8768-b104f6a4be07.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197941methIMAzole 10 MG Oral TabletPSN244d76f1-98e6-4305-8768-b104f6a4be074
197941methimazole 10 MG Oral TabletSCD244d76f1-98e6-4305-8768-b104f6a4be074
197941thiamazole 10 MG Oral TabletSY244d76f1-98e6-4305-8768-b104f6a4be074

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-8227-168788822701100 TABLET in 1 BOTTLE (68788-8227-1) 100 tablet2022-08-080000-00-00NoNoCurrent
68788-8227-36878882270330 TABLET in 1 BOTTLE (68788-8227-3) 30 tablet2022-08-080000-00-00NoNoCurrent