FDA.reportPublic FDA data

PROPYLTHIOURACIL

Product NDC
72162-2072
11-digit product format
721622072
Labeler code
72162
Product ID
72162-2072_a2a5cff0-be4e-4b04-ad87-7ce9b9f2b0fe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PROPYLTHIOURACIL
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA080154
Marketing category
ANDA
Marketing start
2021-03-18
Substance
PROPYLTHIOURACIL
Active strength
50 mg/1
Pharmacologic classes
Thyroid Hormone Synthesis Inhibitor [EPC], Thyroid Hormone Synthesis Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
PROPYLTHIOURACIL
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PROPYLTHIOURACIL50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii721M9407IY
Rxcui198175

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5199f153-e97c-2898-8204-85c73892d5a5Product name220240513

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72162-2072-1PROPYLTHIOURACIL100 in 1 BOTTLETABLET100102
72162-2072-2PROPYLTHIOURACIL180 in 1 BOTTLETABLET180102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2072-1EA - Each72162-207295e43fc5-6acd-484c-84cf-31a3b0c2119412023-09-05
72162-2072-2EA - Each72162-2072381f7b22-30f9-4ada-8ea5-3223e4bfb69312024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2072PROPYLTHIOURACIL TABLET [BRYANT RANCH PREPACK]102Current NDC, 2 package rows20240821_ae65e8b0-91b2-4a3f-8e1a-279e47eee951.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198175propylthiouracil 50 MG Oral TabletPSNae65e8b0-91b2-4a3f-8e1a-279e47eee951102
198175propylthiouracil 50 MG Oral TabletSCDae65e8b0-91b2-4a3f-8e1a-279e47eee951102
198175PTU 50 MG Oral TabletSYae65e8b0-91b2-4a3f-8e1a-279e47eee951102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-2072-172162207201100 TABLET in 1 BOTTLE (72162-2072-1) 100 tablet2023-08-15NoNoHistorical
72162-2072-272162207202180 TABLET in 1 BOTTLE (72162-2072-2) 180 tablet2023-08-15NoNoHistorical