methimazole

Generic: methimazole

Labeler: macleods pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name methimazole
Generic Name methimazole
Labeler macleods pharmaceuticals limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

methimazole 5 mg/1

Manufacturer
Macleods Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 33342-335
Product ID 33342-335_ea518c56-49d7-4770-8ded-21e443e71c3c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209827
Listing Expiration 2026-12-31
Marketing Start 2023-05-24

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 33342335
Hyphenated Format 33342-335

Supplemental Identifiers

RxCUI
197941 197942
UPC
0333342335111 0333342335449 0333342336446 0333342336118
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 ANDA209827 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (33342-335-11)
  • 10 BLISTER PACK in 1 CARTON (33342-335-12) / 10 TABLET in 1 BLISTER PACK
  • 1000 TABLET in 1 BOTTLE (33342-335-44)
source: ndc

Packages (3)

33342-335-11 100 TABLET in 1 BOTTLE (33342-335-11) 33342-335-12 10 BLISTER PACK in 1 CARTON (33342-335-12) / 10 TABLET in 1 BLISTER PACK 33342-335-44 1000 TABLET in 1 BOTTLE (33342-335-44)

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": "ea518c56-49d7-4770-8ded-21e443e71c3c", "openfda": {"nui": ["N0000175918", "N0000175917"], "upc": ["0333342335111", "0333342335449", "0333342336446", "0333342336118"], "unii": ["554Z48XN5E"], "rxcui": ["197941", "197942"], "spl_set_id": ["6f08df05-cc29-45ef-8f6e-12272bfbb0d7"], "pharm_class_epc": ["Thyroid Hormone Synthesis Inhibitor [EPC]"], "pharm_class_moa": ["Thyroid Hormone Synthesis Inhibitors [MoA]"], "manufacturer_name": ["Macleods Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (33342-335-11)", "package_ndc": "33342-335-11", "marketing_start_date": "20230524"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (33342-335-12)  / 10 TABLET in 1 BLISTER PACK", "package_ndc": "33342-335-12", "marketing_start_date": "20230524"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (33342-335-44)", "package_ndc": "33342-335-44", "marketing_start_date": "20230524"}], "brand_name": "Methimazole", "product_id": "33342-335_ea518c56-49d7-4770-8ded-21e443e71c3c", "dosage_form": "TABLET", "pharm_class": ["Thyroid Hormone Synthesis Inhibitor [EPC]", "Thyroid Hormone Synthesis Inhibitors [MoA]"], "product_ndc": "33342-335", "generic_name": "Methimazole", "labeler_name": "Macleods Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Methimazole", "active_ingredients": [{"name": "METHIMAZOLE", "strength": "5 mg/1"}], "application_number": "ANDA209827", "marketing_category": "ANDA", "marketing_start_date": "20230524", "listing_expiration_date": "20261231"}