Propylthiouracil

Product NDC
0480-9242
11-digit product format
004809242
Labeler code
0480
Product ID
0480-9242_0c10d860-d116-4178-9ea5-8c067f2c4c26
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Propylthiouracil
Dosage form
TABLET
Route
ORAL
Labeler
Teva Pharmaceuticals, Inc.
Application
ANDA080172
Marketing category
ANDA
Marketing start
2024-07-10
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
0480-9242-01Propylthiouracil100 in 1 BOTTLETABLET1004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0480-9242-01EA - Each0480-9242fbf20083-1cc2-4c26-a392-e40429c8170312024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0480-9242PROPYLTHIOURACIL TABLET [TEVA PHARMACEUTICALS, INC.]3Current NDC, 1 package rows20250309_804fa92a-a5ba-4be0-aa44-a40a2e89fde6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198175propylthiouracil 50 MG Oral TabletPSN804fa92a-a5ba-4be0-aa44-a40a2e89fde64
198175propylthiouracil 50 MG Oral TabletSCD804fa92a-a5ba-4be0-aa44-a40a2e89fde64
198175PTU 50 MG Oral TabletSY804fa92a-a5ba-4be0-aa44-a40a2e89fde64

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0480-9242-0100480924201100 TABLET in 1 BOTTLE (0480-9242-01) 100 tablet2024-07-10NoNoHistorical