methimazole

Generic: methimazole

Labeler: preferred pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name methimazole
Generic Name methimazole
Labeler preferred pharmaceuticals inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

methimazole 5 mg/1

Manufacturer
Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-8883
Product ID 68788-8883_c063f4c0-d5fe-4b28-b14d-78f73cd7f2c3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202068
Listing Expiration 2026-12-31
Marketing Start 2025-06-02

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 687888883
Hyphenated Format 68788-8883

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 ANDA202068 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (68788-8883-1)
  • 30 TABLET in 1 BOTTLE (68788-8883-3)
source: ndc

Packages (2)

68788-8883-1 100 TABLET in 1 BOTTLE (68788-8883-1) 68788-8883-3 30 TABLET in 1 BOTTLE (68788-8883-3)

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": "c063f4c0-d5fe-4b28-b14d-78f73cd7f2c3", "openfda": {"nui": ["N0000175918", "N0000175917"], "unii": ["554Z48XN5E"], "rxcui": ["197942"], "spl_set_id": ["c063f4c0-d5fe-4b28-b14d-78f73cd7f2c3"], "pharm_class_epc": ["Thyroid Hormone Synthesis Inhibitor [EPC]"], "pharm_class_moa": ["Thyroid Hormone Synthesis Inhibitors [MoA]"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (68788-8883-1)", "package_ndc": "68788-8883-1", "marketing_start_date": "20250602"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (68788-8883-3)", "package_ndc": "68788-8883-3", "marketing_start_date": "20250602"}], "brand_name": "Methimazole", "product_id": "68788-8883_c063f4c0-d5fe-4b28-b14d-78f73cd7f2c3", "dosage_form": "TABLET", "pharm_class": ["Thyroid Hormone Synthesis Inhibitor [EPC]", "Thyroid Hormone Synthesis Inhibitors [MoA]"], "product_ndc": "68788-8883", "generic_name": "methimazole", "labeler_name": "Preferred Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Methimazole", "active_ingredients": [{"name": "METHIMAZOLE", "strength": "5 mg/1"}], "application_number": "ANDA202068", "marketing_category": "ANDA", "marketing_start_date": "20250602", "listing_expiration_date": "20261231"}