methimazole

Generic: methimazole

Labeler: upsher-smith laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name methimazole
Generic Name methimazole
Labeler upsher-smith laboratories, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

methimazole 5 mg/1

Manufacturer
Upsher-Smith Laboratories, LLC

Identifiers & Regulatory

Product NDC 0832-6072
Product ID 0832-6072_91b230bf-7e20-42fa-ba9c-6b986ce85ed2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040547
Listing Expiration 2026-12-31
Marketing Start 2016-07-01

Pharmacologic Class

Established (EPC)
thyroid hormone synthesis inhibitor [epc]
Mechanism of Action
thyroid hormone synthesis inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 08326072
Hyphenated Format 0832-6072

Supplemental Identifiers

RxCUI
197941 197942
UNII
554Z48XN5E
NUI
N0000175918 N0000175917

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name methimazole (source: ndc)
Generic Name methimazole (source: ndc)
Application Number ANDA040547 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (0832-6072-11)
source: ndc

Packages (1)

0832-6072-11 100 TABLET in 1 BOTTLE (0832-6072-11)

Ingredients (1)

methimazole (5 mg/1)

Linked Drug Pages (1)

Methimazole ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "91b230bf-7e20-42fa-ba9c-6b986ce85ed2", "openfda": {"nui": ["N0000175918", "N0000175917"], "unii": ["554Z48XN5E"], "rxcui": ["197941", "197942"], "spl_set_id": ["2185e6e0-7c21-4348-a7b4-d898f50a0184"], "pharm_class_epc": ["Thyroid Hormone Synthesis Inhibitor [EPC]"], "pharm_class_moa": ["Thyroid Hormone Synthesis Inhibitors [MoA]"], "manufacturer_name": ["Upsher-Smith Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (0832-6072-11)", "package_ndc": "0832-6072-11", "marketing_start_date": "20240322"}], "brand_name": "Methimazole", "product_id": "0832-6072_91b230bf-7e20-42fa-ba9c-6b986ce85ed2", "dosage_form": "TABLET", "pharm_class": ["Thyroid Hormone Synthesis Inhibitor [EPC]", "Thyroid Hormone Synthesis Inhibitors [MoA]"], "product_ndc": "0832-6072", "generic_name": "Methimazole", "labeler_name": "Upsher-Smith Laboratories, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Methimazole", "active_ingredients": [{"name": "METHIMAZOLE", "strength": "5 mg/1"}], "application_number": "ANDA040547", "marketing_category": "ANDA", "marketing_start_date": "20160701", "listing_expiration_date": "20261231"}