methimazole

Generic: methimazole

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

Drug Facts

Product Profile

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

methimazole 5 mg/1

Manufacturer
Bionpharma Inc.

Identifiers & Regulatory

Product NDC 69452-328
Product ID 69452-328_141a7912-5f63-fe50-e063-6294a90a99ce
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218149
Listing Expiration 2026-12-31
Marketing Start 2024-03-25

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 69452328
Hyphenated Format 69452-328

Supplemental Identifiers

RxCUI
197941 197942
UPC
0369452328200 0369452329207
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 ANDA218149 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (69452-328-20)
source: ndc

Packages (1)

69452-328-20 100 TABLET in 1 BOTTLE (69452-328-20)

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": "141a7912-5f63-fe50-e063-6294a90a99ce", "openfda": {"nui": ["N0000175918", "N0000175917"], "upc": ["0369452328200", "0369452329207"], "unii": ["554Z48XN5E"], "rxcui": ["197941", "197942"], "spl_set_id": ["141a91d5-b56e-06d6-e063-6394a90a11ba"], "pharm_class_epc": ["Thyroid Hormone Synthesis Inhibitor [EPC]"], "pharm_class_moa": ["Thyroid Hormone Synthesis Inhibitors [MoA]"], "manufacturer_name": ["Bionpharma Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (69452-328-20)", "package_ndc": "69452-328-20", "marketing_start_date": "20240325"}], "brand_name": "Methimazole", "product_id": "69452-328_141a7912-5f63-fe50-e063-6294a90a99ce", "dosage_form": "TABLET", "pharm_class": ["Thyroid Hormone Synthesis Inhibitor [EPC]", "Thyroid Hormone Synthesis Inhibitors [MoA]"], "product_ndc": "69452-328", "generic_name": "methimazole", "labeler_name": "Bionpharma Inc.", "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": "20240325", "listing_expiration_date": "20261231"}