methimazole

Generic: methimazole

Labeler: avpak
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

methimazole 5 mg/1

Manufacturer
AvPAK

Identifiers & Regulatory

Product NDC 50268-495
Product ID 50268-495_41168239-a16a-40e0-e063-6294a90a5c58
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218149
Listing Expiration 2026-12-31
Marketing Start 2025-10-13

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 50268495
Hyphenated Format 50268-495

Supplemental Identifiers

RxCUI
197941 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 ANDA218149 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 50 BLISTER PACK in 1 BOX (50268-495-15) / 1 TABLET in 1 BLISTER PACK (50268-495-11)
source: ndc

Packages (1)

50268-495-15 50 BLISTER PACK in 1 BOX (50268-495-15) / 1 TABLET in 1 BLISTER PACK (50268-495-11)

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": "41168239-a16a-40e0-e063-6294a90a5c58", "openfda": {"nui": ["N0000175918", "N0000175917"], "unii": ["554Z48XN5E"], "rxcui": ["197941", "197942"], "spl_set_id": ["4116774b-6c2b-2c74-e063-6394a90a4955"], "pharm_class_epc": ["Thyroid Hormone Synthesis Inhibitor [EPC]"], "pharm_class_moa": ["Thyroid Hormone Synthesis Inhibitors [MoA]"], "manufacturer_name": ["AvPAK"]}, "finished": true, "packaging": [{"sample": false, "description": "50 BLISTER PACK in 1 BOX (50268-495-15)  / 1 TABLET in 1 BLISTER PACK (50268-495-11)", "package_ndc": "50268-495-15", "marketing_start_date": "20251013"}], "brand_name": "Methimazole", "product_id": "50268-495_41168239-a16a-40e0-e063-6294a90a5c58", "dosage_form": "TABLET", "pharm_class": ["Thyroid Hormone Synthesis Inhibitor [EPC]", "Thyroid Hormone Synthesis Inhibitors [MoA]"], "product_ndc": "50268-495", "generic_name": "methimazole", "labeler_name": "AvPAK", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Methimazole", "active_ingredients": [{"name": "METHIMAZOLE", "strength": "5 mg/1"}], "application_number": "ANDA218149", "marketing_category": "ANDA", "marketing_start_date": "20251013", "listing_expiration_date": "20261231"}