Methimazole

Product NDC
72603-316
11-digit product format
726030316
Labeler code
72603
Product ID
72603-316_d87b19ed-f2f6-41de-a5c0-167bfd2b319f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methimazole
Dosage form
TABLET
Route
ORAL
Labeler
NORTHSTAR RX LLC
Application
ANDA040734
Marketing category
ANDA
Marketing start
2024-08-01
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
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
72603-316-01Methimazole100 in 1 BOTTLETABLET1001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72603-316-01EA - Each72603-316f367efd9-bc21-46a9-b557-e7235e77543612024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72603-316METHIMAZOLE TABLET [NORTHSTAR RX LLC]1Current NDC, 1 package rows20240802_923fec30-90fd-4bd5-beb3-f2ca4fc171ee.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197941methIMAzole 10 MG Oral TabletPSN923fec30-90fd-4bd5-beb3-f2ca4fc171ee1
197942methIMAzole 5 MG Oral TabletPSN923fec30-90fd-4bd5-beb3-f2ca4fc171ee1
197941methimazole 10 MG Oral TabletSCD923fec30-90fd-4bd5-beb3-f2ca4fc171ee1
197942methimazole 5 MG Oral TabletSCD923fec30-90fd-4bd5-beb3-f2ca4fc171ee1
197941thiamazole 10 MG Oral TabletSY923fec30-90fd-4bd5-beb3-f2ca4fc171ee1
197942thiamazole 5 MG Oral TabletSY923fec30-90fd-4bd5-beb3-f2ca4fc171ee1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72603-316-0172603031601100 TABLET in 1 BOTTLE (72603-316-01) 100 tablet2024-08-01NoNoHistorical