Methimazole

Product NDC
64980-265
11-digit product format
649800265
Labeler code
64980
Product ID
64980-265_2ac7fbad-6a1b-4326-9339-b2b3139ce554
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
methimazole
Dosage form
TABLET
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA202068
Marketing category
ANDA
Marketing start
2021-04-22
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
64980-265-01Methimazole100 in 1 BOTTLETABLET1004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64980-265-01EA - Each64980-26519375084-6cbb-4d6c-9e64-c0258bfc9bdd12023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64980-265METHIMAZOLE TABLET [RISING PHARMA HOLDINGS, INC.]4Current NDC, 1 package rows20250326_289ec852-176e-41aa-9f9a-b1f9b4196771.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197941methIMAzole 10 MG Oral TabletPSNf74a8e69-79a1-4061-b42f-447e0780c04f101
197941methimazole 10 MG Oral TabletSCDf74a8e69-79a1-4061-b42f-447e0780c04f101
197941thiamazole 10 MG Oral TabletSYf74a8e69-79a1-4061-b42f-447e0780c04f101
197941methIMAzole 10 MG Oral TabletPSN289ec852-176e-41aa-9f9a-b1f9b41967714
197942methIMAzole 5 MG Oral TabletPSN289ec852-176e-41aa-9f9a-b1f9b41967714
197941methimazole 10 MG Oral TabletSCD289ec852-176e-41aa-9f9a-b1f9b41967714
197942methimazole 5 MG Oral TabletSCD289ec852-176e-41aa-9f9a-b1f9b41967714
197941thiamazole 10 MG Oral TabletSY289ec852-176e-41aa-9f9a-b1f9b41967714
197942thiamazole 5 MG Oral TabletSY289ec852-176e-41aa-9f9a-b1f9b41967714
197941methIMAzole 10 MG Oral TabletPSN253088bf-00f2-489b-984a-682ef9d89e901
197941methimazole 10 MG Oral TabletSCD253088bf-00f2-489b-984a-682ef9d89e901
197941thiamazole 10 MG Oral TabletSY253088bf-00f2-489b-984a-682ef9d89e901

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
64980-265-0164980026501100 TABLET in 1 BOTTLE (64980-265-01) 100 tablet2021-04-22NoNoCurrent