Propylthiouracil

Product NDC
42254-010
11-digit product format
422540010
Labeler code
42254
Product ID
42254-010_ff603c99-6620-4945-acdc-c9150b6f77d4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Propylthiouracil
Dosage form
TABLET
Route
ORAL
Labeler
Rebel Distributors Corp.
Application
ANDA080154
Marketing category
ANDA
Marketing start
1971-07-23
Marketing end
0000-00-00
Substance
PROPYLTHIOURACIL
Active strength
50 mg/1
Pharmacologic classes
Thyroid Hormone Synthesis Inhibitor [EPC],Thyroid Hormone Synthesis Inhibitors [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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
42254-010-302019-09-24C16284748780-19350213a-3cce-c013-e053-90daa90a1393PROPYLTHIOURACIL TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42254-010-30Propylthiouracil30 in 1 BOTTLETABLET301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42254-010-30EA - Each42254-010e2610a56-c894-4970-bea9-e3b23771bcf312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PROPYLTHIOURACILACTIVE INGREDIENT721M9407IYPROPYLTHIOURACIL TABLET [REBEL DISTRIBUTORS CORP.]1
PROPYLTHIOURACILACTIVE MOIETY721M9407IYPROPYLTHIOURACIL TABLET [REBEL DISTRIBUTORS CORP.]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKPROPYLTHIOURACIL TABLET [REBEL DISTRIBUTORS CORP.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPROPYLTHIOURACIL TABLET [REBEL DISTRIBUTORS CORP.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PROPYLTHIOURACIL TABLET [REBEL DISTRIBUTORS CORP.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2PROPYLTHIOURACIL TABLET [REBEL DISTRIBUTORS CORP.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPROPYLTHIOURACIL TABLET [REBEL DISTRIBUTORS CORP.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42254-010PROPYLTHIOURACIL TABLET [REBEL DISTRIBUTORS CORP.]1Legacy NDC, 1 package rows20111118_ff603c99-6620-4945-acdc-c9150b6f77d4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198175propylthiouracil 50 MG Oral TabletPSNff603c99-6620-4945-acdc-c9150b6f77d41
198175propylthiouracil 50 MG Oral TabletSCDff603c99-6620-4945-acdc-c9150b6f77d41
198175PTU 50 MG Oral TabletSYff603c99-6620-4945-acdc-c9150b6f77d41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
42254-010-304225400103030 in 1 BOTTLEHistorical