methimazole

Generic: methimazole

Labeler: northstar rx llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name methimazole
Generic Name methimazole
Labeler northstar rx llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

methimazole 5 mg/1

Manufacturer
NORTHSTAR RX LLC

Identifiers & Regulatory

Product NDC 72603-315
Product ID 72603-315_d87b19ed-f2f6-41de-a5c0-167bfd2b319f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040734
Listing Expiration 2026-12-31
Marketing Start 2024-08-01

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 72603315
Hyphenated Format 72603-315

Supplemental Identifiers

RxCUI
197941 197942
UPC
0372603315011 0372603316018
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 ANDA040734 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (72603-315-01)
source: ndc

Packages (1)

72603-315-01 100 TABLET in 1 BOTTLE (72603-315-01)

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": "d87b19ed-f2f6-41de-a5c0-167bfd2b319f", "openfda": {"nui": ["N0000175918", "N0000175917"], "upc": ["0372603315011", "0372603316018"], "unii": ["554Z48XN5E"], "rxcui": ["197941", "197942"], "spl_set_id": ["923fec30-90fd-4bd5-beb3-f2ca4fc171ee"], "pharm_class_epc": ["Thyroid Hormone Synthesis Inhibitor [EPC]"], "pharm_class_moa": ["Thyroid Hormone Synthesis Inhibitors [MoA]"], "manufacturer_name": ["NORTHSTAR RX LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (72603-315-01)", "package_ndc": "72603-315-01", "marketing_start_date": "20240801"}], "brand_name": "Methimazole", "product_id": "72603-315_d87b19ed-f2f6-41de-a5c0-167bfd2b319f", "dosage_form": "TABLET", "pharm_class": ["Thyroid Hormone Synthesis Inhibitor [EPC]", "Thyroid Hormone Synthesis Inhibitors [MoA]"], "product_ndc": "72603-315", "generic_name": "Methimazole", "labeler_name": "NORTHSTAR RX LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Methimazole", "active_ingredients": [{"name": "METHIMAZOLE", "strength": "5 mg/1"}], "application_number": "ANDA040734", "marketing_category": "ANDA", "marketing_start_date": "20240801", "listing_expiration_date": "20261231"}