methimazole

Generic: methimazole

Labeler: square pharmaceuticals plc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name methimazole
Generic Name methimazole
Labeler square pharmaceuticals plc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

methimazole 5 mg/1

Manufacturer
SQUARE PHARMACEUTICALS PLC.

Identifiers & Regulatory

Product NDC 76483-082
Product ID 76483-082_3b305195-ceb2-495c-82c0-fa90bd5c1780
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218830
Listing Expiration 2026-12-31
Marketing Start 2024-12-31

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 76483082
Hyphenated Format 76483-082

Supplemental Identifiers

RxCUI
197941 197942
UPC
0376483083008 0376483082001
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 ANDA218830 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (76483-082-00)
source: ndc

Packages (1)

76483-082-00 100 TABLET in 1 BOTTLE (76483-082-00)

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": "3b305195-ceb2-495c-82c0-fa90bd5c1780", "openfda": {"nui": ["N0000175918", "N0000175917"], "upc": ["0376483083008", "0376483082001"], "unii": ["554Z48XN5E"], "rxcui": ["197941", "197942"], "spl_set_id": ["33e065a1-dd4e-43f9-a841-f96e633fc850"], "pharm_class_epc": ["Thyroid Hormone Synthesis Inhibitor [EPC]"], "pharm_class_moa": ["Thyroid Hormone Synthesis Inhibitors [MoA]"], "manufacturer_name": ["SQUARE PHARMACEUTICALS PLC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (76483-082-00)", "package_ndc": "76483-082-00", "marketing_start_date": "20241231"}], "brand_name": "methimazole", "product_id": "76483-082_3b305195-ceb2-495c-82c0-fa90bd5c1780", "dosage_form": "TABLET", "pharm_class": ["Thyroid Hormone Synthesis Inhibitor [EPC]", "Thyroid Hormone Synthesis Inhibitors [MoA]"], "product_ndc": "76483-082", "generic_name": "methimazole", "labeler_name": "SQUARE PHARMACEUTICALS PLC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "methimazole", "active_ingredients": [{"name": "METHIMAZOLE", "strength": "5 mg/1"}], "application_number": "ANDA218830", "marketing_category": "ANDA", "marketing_start_date": "20241231", "listing_expiration_date": "20261231"}