FDA.reportPublic FDA data

Methimazole

Product NDC
72162-1802
11-digit product format
721621802
Labeler code
72162
Product ID
72162-1802_338daeea-483f-25a4-e063-6294a90a5c11
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
methimazole
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA040350
Marketing category
ANDA
Marketing start
2022-03-14
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
Rxcui197942

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
72162-1802-1Methimazole100 in 1 BOTTLETABLET100107
72162-1802-2Methimazole100 in 1 BOTTLETABLET100107
72162-1802-4Methimazole180 in 1 BOTTLETABLET180107
72162-1802-5Methimazole500 in 1 BOTTLETABLET500107
72162-1802-7Methimazole500 in 1 BOTTLETABLET500107
72162-1802-9Methimazole90 in 1 BOTTLETABLET90107

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-1802-1EA - Each72162-180234dba2ed-2140-4c9e-b457-cbe3b0a9310c12023-05-05
72162-1802-2EA - Each72162-1802d3a22180-a5f1-424e-b48e-933bd8a09e9b12025-05-14
72162-1802-4EA - Each72162-18028f8b93b5-0bbc-450f-a407-c018e23c6ba112025-05-14
72162-1802-5EA - Each72162-18021e99c14b-0324-40cb-8250-0bc26cf2909e12023-05-05
72162-1802-7EA - Each72162-18027d0e0662-5af3-49bd-96fc-4e651d4ada6712025-05-14
72162-1802-9EA - Each72162-1802636ed062-b5d0-48e4-bae4-8068b5c85a5612024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-1802METHIMAZOLE TABLET [BRYANT RANCH PREPACK]107Current NDC, 6 package rows20250426_94d2e57b-685f-4cfd-a5a5-129e869c794c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197942methIMAzole 5 MG Oral TabletPSN94d2e57b-685f-4cfd-a5a5-129e869c794c107
197942methimazole 5 MG Oral TabletSCD94d2e57b-685f-4cfd-a5a5-129e869c794c107
197942thiamazole 5 MG Oral TabletSY94d2e57b-685f-4cfd-a5a5-129e869c794c107

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-1802-172162180201100 TABLET in 1 BOTTLE (72162-1802-1) 100 tablet2023-03-30NoNoCurrent
72162-1802-272162180202100 TABLET in 1 BOTTLE (72162-1802-2) 100 tablet2024-06-18NoNoCurrent
72162-1802-472162180204180 TABLET in 1 BOTTLE (72162-1802-4) 180 tablet2022-04-15NoNoCurrent
72162-1802-572162180205500 TABLET in 1 BOTTLE (72162-1802-5) 500 tablet2023-03-30NoNoCurrent
72162-1802-772162180207500 TABLET in 1 BOTTLE (72162-1802-7) 500 tablet2025-04-15NoNoCurrent
72162-1802-97216218020990 TABLET in 1 BOTTLE (72162-1802-9) 90 tablet2024-07-16NoNoCurrent