FDA.reportPublic FDA data

PROPYLTHIOURACIL

Product NDC
70752-171
11-digit product format
707520171
Labeler code
70752
Product ID
70752-171_4a15d422-7a6a-4b92-a4cf-3632250c9580
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PROPYLTHIOURACIL
Dosage form
TABLET
Route
ORAL
Labeler
QUAGEN PHARMACEUTICALS LLC
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70752-171-102023-02-15C16284748780-1f386c64a-2530-0266-e053-dadaa90a7c1aPropylthiouracil Tablets, USP
70752-171-112023-02-15C16284748780-1f386c64a-2530-0266-e053-dadaa90a7c1aPropylthiouracil Tablets, USP
70752-171-102023-01-30C16284748780-1f386c64a-2530-0266-e053-dadaa90a7c1aPropylthiouracil Tablets, USP
70752-171-112023-01-30C16284748780-1f386c64a-2530-0266-e053-dadaa90a7c1aPropylthiouracil Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70752-171-10PROPYLTHIOURACIL100 in 1 BOTTLETABLET1002
70752-171-11PROPYLTHIOURACIL1000 in 1 BOTTLETABLET10002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70752-171-10EA - Each70752-171dad4112d-403c-499f-9ad1-cf837691d7bc12021-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70752-171PROPYLTHIOURACIL TABLET [QUAGEN PHARMACEUTICALS LLC]2Current NDC, Legacy NDC, 2 package rows20230217_84eae11a-b572-4570-b288-ac2cdd374186.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
198175propylthiouracil 50 MG Oral TabletPSNa032648a-a6e4-4356-a483-8eee03779030100
198175propylthiouracil 50 MG Oral TabletSCDa032648a-a6e4-4356-a483-8eee03779030100
198175PTU 50 MG Oral TabletSYa032648a-a6e4-4356-a483-8eee03779030100
198175propylthiouracil 50 MG Oral TabletPSN84eae11a-b572-4570-b288-ac2cdd3741862
198175propylthiouracil 50 MG Oral TabletSCD84eae11a-b572-4570-b288-ac2cdd3741862
198175PTU 50 MG Oral TabletSY84eae11a-b572-4570-b288-ac2cdd3741862

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70752-171-1070752017110100 TABLET in 1 BOTTLE (70752-171-10) 100 tablet2021-03-180000-00-00NoNoCurrent
70752-171-11707520171111000 TABLET in 1 BOTTLE (70752-171-11) 1000 tablet2021-03-180000-00-00NoNoCurrent