propylthiouracil

Generic: propylthiouracil

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

Drug Facts

Product Profile

Brand Name propylthiouracil
Generic Name propylthiouracil
Labeler chartwell rx, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

propylthiouracil 50 mg/1

Manufacturer
Chartwell RX, LLC

Identifiers & Regulatory

Product NDC 62135-606
Product ID 62135-606_0d6cc91d-1da2-25ae-e063-6394a90aa6a0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA080016
Listing Expiration 2026-12-31
Marketing Start 1982-01-01

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 62135606
Hyphenated Format 62135-606

Supplemental Identifiers

RxCUI
198175
UPC
0362135606909
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 ANDA080016 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 90 TABLET in 1 BOTTLE (62135-606-90)
source: ndc

Packages (1)

62135-606-90 90 TABLET in 1 BOTTLE (62135-606-90)

Ingredients (1)

propylthiouracil (50 mg/1)

Linked Drug Pages (1)

Propylthiouracil ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "0d6cc91d-1da2-25ae-e063-6394a90aa6a0", "openfda": {"nui": ["N0000175918", "N0000175917"], "upc": ["0362135606909"], "unii": ["721M9407IY"], "rxcui": ["198175"], "spl_set_id": ["53c5f586-3e72-479d-89ba-379683c8f6ba"], "pharm_class_epc": ["Thyroid Hormone Synthesis Inhibitor [EPC]"], "pharm_class_moa": ["Thyroid Hormone Synthesis Inhibitors [MoA]"], "manufacturer_name": ["Chartwell RX, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET in 1 BOTTLE (62135-606-90)", "package_ndc": "62135-606-90", "marketing_start_date": "20231219"}], "brand_name": "Propylthiouracil", "product_id": "62135-606_0d6cc91d-1da2-25ae-e063-6394a90aa6a0", "dosage_form": "TABLET", "pharm_class": ["Thyroid Hormone Synthesis Inhibitor [EPC]", "Thyroid Hormone Synthesis Inhibitors [MoA]"], "product_ndc": "62135-606", "generic_name": "Propylthiouracil", "labeler_name": "Chartwell RX, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Propylthiouracil", "active_ingredients": [{"name": "PROPYLTHIOURACIL", "strength": "50 mg/1"}], "application_number": "ANDA080016", "marketing_category": "ANDA", "marketing_start_date": "19820101", "listing_expiration_date": "20261231"}