propylthiouracil

Generic: propylthiouracil

Labeler: actavis pharma, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name propylthiouracil
Generic Name propylthiouracil
Labeler actavis pharma, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

propylthiouracil 50 mg/1

Manufacturer
Actavis Pharma, Inc.

Identifiers & Regulatory

Product NDC 0228-2348
Product ID 0228-2348_6c5ff585-8874-4525-957c-87e70d822151
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA080172
Marketing Start 2006-01-15
Marketing End 2026-04-30

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 02282348
Hyphenated Format 0228-2348

Supplemental Identifiers

RxCUI
198175
UNII
721M9407IY
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 propylthiouracil (source: ndc)
Generic Name propylthiouracil (source: ndc)
Application Number ANDA080172 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (0228-2348-10)
source: ndc

Packages (1)

Ingredients (1)

propylthiouracil (50 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "6c5ff585-8874-4525-957c-87e70d822151", "openfda": {"nui": ["N0000175918", "N0000175917"], "unii": ["721M9407IY"], "rxcui": ["198175"], "spl_set_id": ["a57c49ae-d659-49fa-84e3-cf6d1f9e6f97"], "pharm_class_epc": ["Thyroid Hormone Synthesis Inhibitor [EPC]"], "pharm_class_moa": ["Thyroid Hormone Synthesis Inhibitors [MoA]"], "manufacturer_name": ["Actavis Pharma, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (0228-2348-10)", "package_ndc": "0228-2348-10", "marketing_end_date": "20260430", "marketing_start_date": "20060115"}], "brand_name": "Propylthiouracil", "product_id": "0228-2348_6c5ff585-8874-4525-957c-87e70d822151", "dosage_form": "TABLET", "pharm_class": ["Thyroid Hormone Synthesis Inhibitor [EPC]", "Thyroid Hormone Synthesis Inhibitors [MoA]"], "product_ndc": "0228-2348", "generic_name": "Propylthiouracil", "labeler_name": "Actavis Pharma, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Propylthiouracil", "active_ingredients": [{"name": "PROPYLTHIOURACIL", "strength": "50 mg/1"}], "application_number": "ANDA080172", "marketing_category": "ANDA", "marketing_end_date": "20260430", "marketing_start_date": "20060115"}