methimazole

Product NDC
72578-212
11-digit product format
725780212
Labeler code
72578
Product ID
72578-212_ce881707-0cf8-49b8-af99-367197e27bfa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
methimazole
Dosage form
TABLET
Route
ORAL
Labeler
Viona Pharmaceuticals Inc.
Application
ANDA218830
Marketing category
ANDA
Marketing start
2025-09-10
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
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
72578-212-01methimazole100 in 1 BOTTLETABLET1001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72578-212-01EA - Each72578-212b4461b63-7711-4aa7-9648-f73ccd74d31312025-11-13

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197941methIMAzole 10 MG Oral TabletPSN05a8fed7-f805-4c59-8840-630174b6d1301
197942methIMAzole 5 MG Oral TabletPSN05a8fed7-f805-4c59-8840-630174b6d1301
197942methIMAzole 5 MG Oral TabletPSN490f04db-cb51-bde7-e063-6394a90a55461
197941methimazole 10 MG Oral TabletSCD05a8fed7-f805-4c59-8840-630174b6d1301
197942methimazole 5 MG Oral TabletSCD05a8fed7-f805-4c59-8840-630174b6d1301
197942methimazole 5 MG Oral TabletSCD490f04db-cb51-bde7-e063-6394a90a55461
197941thiamazole 10 MG Oral TabletSY05a8fed7-f805-4c59-8840-630174b6d1301
197942thiamazole 5 MG Oral TabletSY05a8fed7-f805-4c59-8840-630174b6d1301
197942thiamazole 5 MG Oral TabletSY490f04db-cb51-bde7-e063-6394a90a55461

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72578-212-0172578021201100 TABLET in 1 BOTTLE (72578-212-01) 100 tablet2025-09-10NoNoHistorical