FDA Product

Methimazole

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Product Name

Methimazole

FDA Product Code

60687-669

Regulatory Information

NDC Product Code

60687-669

Application Number

ANDA040350

Marketing Category

C73584

Effective Date

February 7, 2023

Territorial Authority

USA

FDA Title

Methimazole Tablets, USP Rx only 8466901/0322F

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

3

Company Information

ManufacturerAmerican Health Packaging

DUNS Number

929561009

Active Ingredients

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

Quantity: 5 mg in 1 1

Code: 554Z48XN5E

Class Code: ACTIB

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

Active Moieties

METHIMAZOLE

Code: 554Z48XN5E

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