Methimazole

Product NDC
50268-496
11-digit product format
502680496
Labeler code
50268
Product ID
50268-496_41168239-a16a-40e0-e063-6294a90a5c58
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
methimazole
Dosage form
TABLET
Route
ORAL
Labeler
AvPAK
Application
ANDA218149
Marketing category
ANDA
Marketing start
2025-10-13
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
50268-496-11Methimazole1 in 1 BLISTER PACKTABLET11
50268-496-15Methimazole50 in 1 BOXTABLET501

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-496-11EA - Each50268-49613523b7a-c419-4c41-86ea-e5fb6d49fb9412025-12-16
50268-496-15EA - Each50268-49604ee262c-2d35-4b41-b7e8-02b3a9d28f6912025-12-16

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197941methIMAzole 10 MG Oral TabletPSN4116774b-6c2b-2c74-e063-6394a90a49551
197942methIMAzole 5 MG Oral TabletPSN4116774b-6c2b-2c74-e063-6394a90a49551
197941methimazole 10 MG Oral TabletSCD4116774b-6c2b-2c74-e063-6394a90a49551
197942methimazole 5 MG Oral TabletSCD4116774b-6c2b-2c74-e063-6394a90a49551
197941thiamazole 10 MG Oral TabletSY4116774b-6c2b-2c74-e063-6394a90a49551
197942thiamazole 5 MG Oral TabletSY4116774b-6c2b-2c74-e063-6394a90a49551

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50268-496-11502680496111 in 1 BLISTER PACKHistorical
50268-496-155026804961550 BLISTER PACK in 1 BOX (50268-496-15) / 1 TABLET in 1 BLISTER PACK (50268-496-11) 50 blister pack2025-10-13NoNoCurrent