methimazole

Generic: methimazole

Labeler: coupler llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name methimazole
Generic Name methimazole
Labeler coupler llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

methimazole 5 mg/1

Manufacturer
Coupler LLC

Identifiers & Regulatory

Product NDC 67046-1651
Product ID 67046-1651_490f045d-bcd2-3eb2-e063-6294a90a6d59
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218830
Listing Expiration 2027-12-31
Marketing Start 2026-01-23

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 670461651
Hyphenated Format 67046-1651

Supplemental Identifiers

RxCUI
197942
UNII
554Z48XN5E
NUI
N0000175918 N0000175917

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
  • 30 TABLET in 1 BLISTER PACK (67046-1651-3)
source: ndc

Packages (1)

67046-1651-3 30 TABLET in 1 BLISTER PACK (67046-1651-3)

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": "490f045d-bcd2-3eb2-e063-6294a90a6d59", "openfda": {"nui": ["N0000175918", "N0000175917"], "unii": ["554Z48XN5E"], "rxcui": ["197942"], "spl_set_id": ["490f04db-cb51-bde7-e063-6394a90a5546"], "pharm_class_epc": ["Thyroid Hormone Synthesis Inhibitor [EPC]"], "pharm_class_moa": ["Thyroid Hormone Synthesis Inhibitors [MoA]"], "manufacturer_name": ["Coupler LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BLISTER PACK (67046-1651-3)", "package_ndc": "67046-1651-3", "marketing_start_date": "20260123"}], "brand_name": "methimazole", "product_id": "67046-1651_490f045d-bcd2-3eb2-e063-6294a90a6d59", "dosage_form": "TABLET", "pharm_class": ["Thyroid Hormone Synthesis Inhibitor [EPC]", "Thyroid Hormone Synthesis Inhibitors [MoA]"], "product_ndc": "67046-1651", "generic_name": "methimazole", "labeler_name": "Coupler LLC", "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": "20260123", "listing_expiration_date": "20271231"}