Propylthiouracil

Product NDC
0228-2348
11-digit product format
002282348
Labeler code
0228
Product ID
0228-2348_20e93a90-36d0-4007-86ec-2094411b381b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Propylthiouracil
Dosage form
TABLET
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
ANDA080172
Marketing category
ANDA
Marketing start
2006-01-15
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
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0228-2348-10EA - Each0228-2348c2f7046e-540e-4d78-b660-81a19eecc51112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PROPYLTHIOURACILACTIVE INGREDIENT721M9407IYPROPYLTHIOURACIL TABLET [ACTAVIS ELIZABETH LLC]6
PROPYLTHIOURACILACTIVE MOIETY721M9407IYPROPYLTHIOURACIL TABLET [ACTAVIS ELIZABETH LLC]6
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPROPYLTHIOURACIL TABLET [ACTAVIS ELIZABETH LLC]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PROPYLTHIOURACIL TABLET [ACTAVIS ELIZABETH LLC]6
POVIDONEINACTIVE INGREDIENTFZ989GH94EPROPYLTHIOURACIL TABLET [ACTAVIS ELIZABETH LLC]6
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PROPYLTHIOURACIL TABLET [ACTAVIS ELIZABETH LLC]6
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPROPYLTHIOURACIL TABLET [ACTAVIS ELIZABETH LLC]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0228-2348PROPYLTHIOURACIL TABLET [ACTAVIS PHARMA, INC.]22Legacy NDC20240721_a57c49ae-d659-49fa-84e3-cf6d1f9e6f97.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0228-2348-1000228234810100 TABLET in 1 BOTTLE (0228-2348-10) 100 tablet2006-01-150000-00-00NoNoCurrent