FDA.reportPublic FDA data

Propylthiouracil

Product NDC
67253-651
11-digit product format
672530651
Labeler code
67253
Product ID
67253-651_99a1da9d-39dd-4fc1-8470-c486e5c8b850
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Propylthiouracil
Dosage form
TABLET
Route
ORAL
Labeler
Endo USA, Inc.
Application
NDA006188
Marketing category
NDA
Marketing start
1947-07-28
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67253-651-102023-10-20C16284748780-10191ceaa-7123-198a-e063-dbdaa90aec3ePROPYLTHIOURACIL TABLETS, USP
67253-651-112023-10-20C16284748780-10191ceaa-7123-198a-e063-dbdaa90aec3ePROPYLTHIOURACIL TABLETS, USP
67253-651-102023-07-28C16284748780-10191ceaa-7123-198a-e063-dbdaa90aec3ePROPYLTHIOURACIL TABLETS, USP
67253-651-112023-07-28C16284748780-10191ceaa-7123-198a-e063-dbdaa90aec3ePROPYLTHIOURACIL TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67253-651-10Propylthiouracil100 in 1 BOTTLETABLET10017
67253-651-11Propylthiouracil1000 in 1 BOTTLETABLET100017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67253-651-10EA - Each67253-6516d895d06-09a1-46ca-af5f-f5f7f9475bde12014-05-02
67253-651-11EA - Each67253-651be06e68e-2120-4a94-b48c-fe3f41c8faec12014-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PROPYLTHIOURACILACTIVE INGREDIENT721M9407IYPROPYLTHIOURACIL TABLET [DAVA PHARMACEUTICALS, INC.]7
PROPYLTHIOURACILACTIVE MOIETY721M9407IYPROPYLTHIOURACIL TABLET [DAVA PHARMACEUTICALS, INC.]7
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPROPYLTHIOURACIL TABLET [DAVA PHARMACEUTICALS, INC.]7
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0PROPYLTHIOURACIL TABLET [DAVA PHARMACEUTICALS, INC.]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PROPYLTHIOURACIL TABLET [DAVA PHARMACEUTICALS, INC.]7
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUPROPYLTHIOURACIL TABLET [DAVA PHARMACEUTICALS, INC.]7
SODIUM GLYCOLATEINACTIVE INGREDIENTB75E535IMIPROPYLTHIOURACIL TABLET [DAVA PHARMACEUTICALS, INC.]7
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPROPYLTHIOURACIL TABLET [DAVA PHARMACEUTICALS, INC.]7
PROPYLTHIOURACILACTIVE INGREDIENT721M9407IYPROPYLTHIOURACIL TABLET [AMERICAN HEALTH PACKAGING]1
PROPYLTHIOURACILACTIVE MOIETY721M9407IYPROPYLTHIOURACIL TABLET [AMERICAN HEALTH PACKAGING]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPROPYLTHIOURACIL TABLET [AMERICAN HEALTH PACKAGING]1
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0PROPYLTHIOURACIL TABLET [AMERICAN HEALTH PACKAGING]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PROPYLTHIOURACIL TABLET [AMERICAN HEALTH PACKAGING]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUPROPYLTHIOURACIL TABLET [AMERICAN HEALTH PACKAGING]1
SODIUM GLYCOLATEINACTIVE INGREDIENTB75E535IMIPROPYLTHIOURACIL TABLET [AMERICAN HEALTH PACKAGING]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPROPYLTHIOURACIL TABLET [AMERICAN HEALTH PACKAGING]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67253-651PROPYLTHIOURACIL TABLET [ENDO USA, INC.]17Current NDC, Legacy NDC, 2 package rows20250109_b0c23a2c-b250-4c0d-9b2a-c1483faa2ca0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198175propylthiouracil 50 MG Oral TabletPSNb0c23a2c-b250-4c0d-9b2a-c1483faa2ca017
198175propylthiouracil 50 MG Oral TabletSCDb0c23a2c-b250-4c0d-9b2a-c1483faa2ca017
198175PTU 50 MG Oral TabletSYb0c23a2c-b250-4c0d-9b2a-c1483faa2ca017
198175propylthiouracil 50 MG Oral TabletPSNd819e532-09ac-434a-84a6-636c4204c7aa6
198175propylthiouracil 50 MG Oral TabletSCDd819e532-09ac-434a-84a6-636c4204c7aa6
198175PTU 50 MG Oral TabletSYd819e532-09ac-434a-84a6-636c4204c7aa6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67253-651-1067253065110100 TABLET in 1 BOTTLE (67253-651-10) 100 tablet1947-07-280000-00-00NoNoCurrent
67253-651-11672530651111000 TABLET in 1 BOTTLE (67253-651-11) 1000 tablet1947-07-282028-07-31NoNoCurrent