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 10 mg/1

Manufacturer
AvPAK

Identifiers & Regulatory

Product NDC 50268-496
Product ID 50268-496_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 50268496
Hyphenated Format 50268-496

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
  • 10 mg/1
source: ndc
Packaging
  • 50 BLISTER PACK in 1 BOX (50268-496-15) / 1 TABLET in 1 BLISTER PACK (50268-496-11)
source: ndc

Packages (1)

50268-496-15 50 BLISTER PACK in 1 BOX (50268-496-15) / 1 TABLET in 1 BLISTER PACK (50268-496-11)

Ingredients (1)

methimazole (10 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 (50268-496-15)  / 1 TABLET in 1 BLISTER PACK (50268-496-11)", "package_ndc": "50268-496-15", "marketing_start_date": "20251013"}], "brand_name": "Methimazole", "product_id": "50268-496_41168239-a16a-40e0-e063-6294a90a5c58", "dosage_form": "TABLET", "pharm_class": ["Thyroid Hormone Synthesis Inhibitor [EPC]", "Thyroid Hormone Synthesis Inhibitors [MoA]"], "product_ndc": "50268-496", "generic_name": "methimazole", "labeler_name": "AvPAK", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Methimazole", "active_ingredients": [{"name": "METHIMAZOLE", "strength": "10 mg/1"}], "application_number": "ANDA218149", "marketing_category": "ANDA", "marketing_start_date": "20251013", "listing_expiration_date": "20261231"}