Methimazole

Product NDC
11788-012
11-digit product format
117880012
Labeler code
11788
Product ID
11788-012_6fdbe6c8-2389-42d3-982c-05174f494709
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methimazole
Dosage form
TABLET
Route
ORAL
Labeler
AiPing Pharmaceutical, Inc.
Application
ANDA040547
Marketing category
ANDA
Marketing start
2026-04-01
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Methimazole
Listing expiration
2027-12-31

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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11788-012-01Methimazole100 in 1 BOTTLETABLET1001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11788-012-01EA - Each11788-012801441ba-770f-4606-a457-fd1abcd9658912026-04-20

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197941methIMAzole 10 MG Oral TabletPSN06bb4bcc-5e47-48b6-a76c-648f846704e81
197942methIMAzole 5 MG Oral TabletPSN06bb4bcc-5e47-48b6-a76c-648f846704e81
197941methimazole 10 MG Oral TabletSCD06bb4bcc-5e47-48b6-a76c-648f846704e81
197942methimazole 5 MG Oral TabletSCD06bb4bcc-5e47-48b6-a76c-648f846704e81
197941thiamazole 10 MG Oral TabletSY06bb4bcc-5e47-48b6-a76c-648f846704e81
197942thiamazole 5 MG Oral TabletSY06bb4bcc-5e47-48b6-a76c-648f846704e81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
11788-012-0111788001201100 TABLET in 1 BOTTLE (11788-012-01) 100 tablet2026-04-01NoNoCurrent