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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct42254-010IInactivated by FDA2026-08-17
excluded packagepackage42254-01042254-010-30IInactivated by FDA2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 44 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage42254-010-30d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage42254-010-30f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage42254-010-302ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage42254-010-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage42254-010-30cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage42254-010-30cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage42254-010-30302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage42254-010-30ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage42254-010-300efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage42254-010-30ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage42254-010-30367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage42254-010-30557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage42254-010-308af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage42254-010-30834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage42254-010-301332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage42254-010-30fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage42254-010-3086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage42254-010-30bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage42254-010-308dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage42254-010-30e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage42254-010-309bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage42254-010-30110d247fa046…a55b01930146…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A080154-001PROPYLTHIOURACILPROPYLTHIOURACIL50MGTABLET / ORALBDApproved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A080154-001BD

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A080154-001PROPYLTHIOURACIL50MGTABLET / ORALBDApproved before 1982caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A080154-001PROPYLTHIOURACIL50MGTABLET / ORALBDApproved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A080154-001PROPYLTHIOURACIL50MGTABLET / ORALBDApproved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08A080154-001PROPYLTHIOURACIL50MGTABLET / ORALBDApproved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A080154-001PROPYLTHIOURACIL50MGTABLET / ORALBDApproved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A080154-001PROPYLTHIOURACIL50MGTABLET / ORALBDApproved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A080154-001PROPYLTHIOURACIL50MGTABLET / ORALBDApproved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A080154-001PROPYLTHIOURACIL50MGTABLET / ORALBDApproved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A080154-001PROPYLTHIOURACIL50MGTABLET / ORALBDApproved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A080154-001PROPYLTHIOURACIL50MGTABLET / ORALBDApproved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A080154-001PROPYLTHIOURACIL50MGTABLET / ORALBDApproved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A080154-001PROPYLTHIOURACIL50MGTABLET / ORALBDApproved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A080154-001PROPYLTHIOURACIL50MGTABLET / ORALBDApproved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A080154-001PROPYLTHIOURACIL50MGTABLET / ORALBDApproved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05A080154-001PROPYLTHIOURACIL50MGTABLET / ORALBDApproved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A080154-001PROPYLTHIOURACIL50MGTABLET / ORALBDApproved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A080154-001PROPYLTHIOURACIL50MGTABLET / ORALBDApproved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A080154-001PROPYLTHIOURACIL50MGTABLET / ORALBDApproved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A080154-001PROPYLTHIOURACIL50MGTABLET / ORALApproved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A080154-001PROPYLTHIOURACIL50MGTABLET / ORALBDApproved before 1982bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A080154-001PROPYLTHIOURACIL50MGTABLET / ORALBDApproved before 1982782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A080154-001PROPYLTHIOURACIL50MGTABLET / ORALBDApproved before 198287673890dc5c…
2021-03-12 10:30 UTC2021-03A080154-001PROPYLTHIOURACIL50MGTABLET / ORALApproved before 19825aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A080154-001PROPYLTHIOURACIL50MGTABLET / ORALApproved before 19828869cabd3fbd…
2020-11-12 02:37 UTC2020-11A080154-001PROPYLTHIOURACIL50MGTABLET / ORALApproved before 1982c0c555d07b60…
2019-12-14 00:12 UTC2019-12A080154-001PROPYLTHIOURACIL50MGTABLET / ORALApproved before 19823f01610625f2…
2019-09-15 20:21 UTC2019-09A080154-001PROPYLTHIOURACIL50MGTABLET / ORALApproved before 1982b00525d2431f…
2019-07-19 19:46 UTC2019-07A080154-001PROPYLTHIOURACIL50MGTABLET / ORALApproved before 1982ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A080154-001PROPYLTHIOURACIL50MGTABLET / ORALBDApproved before 19826a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A080154-001PROPYLTHIOURACIL50MGTABLET / ORALBDApproved before 19821c564ffb4f44…
2023-12-20 04:57 UTC2023-12A080154-001PROPYLTHIOURACIL50MGTABLET / ORALBDApproved before 1982ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A080154-001PROPYLTHIOURACIL50MGTABLET / ORALBDApproved before 1982a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A080154-001PROPYLTHIOURACIL50MGTABLET / ORALBDApproved before 19829b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A080154-001PROPYLTHIOURACIL50MGTABLET / ORALBDApproved before 1982a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A080154-001PROPYLTHIOURACIL50MGTABLET / ORALBDApproved before 19823f0d92c62455…
2023-05-13 08:27 UTC2023-05A080154-001PROPYLTHIOURACIL50MGTABLET / ORALBDApproved before 1982053a50430f4f…
2023-01-26 05:58 UTC2023-01A080154-001PROPYLTHIOURACIL50MGTABLET / ORALBDApproved before 19823bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A080154-001PROPYLTHIOURACIL50MGTABLET / ORALBDApproved before 19823a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A080154-001PROPYLTHIOURACIL50MGTABLET / ORALBDApproved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A080154-001PROPYLTHIOURACIL50MGTABLET / ORALBDApproved before 1982e64feba35796…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A080154-001BD1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A080154-001BD1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A080154-001BD131067a03dcf5…
2025-08-23 18:47 UTC2025-08A080154-001BD16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A080154-001BD1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A080154-001BD1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A080154-001BD103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A080154-001BD12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A080154-001BD15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A080154-001BD1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A080154-001BD1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A080154-001BD179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A080154-001BD1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A080154-001BD11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A080154-001BD18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A080154-001BD15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A080154-001BD15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A080154-001BD14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A080154-001BD1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A080154-001BD1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A080154-001BD187673890dc5c…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A080154-001BD16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A080154-001BD11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A080154-001BD1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A080154-001BD1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A080154-001BD19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A080154-001BD1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A080154-001BD13f0d92c62455…
2023-05-13 08:27 UTC2023-05A080154-001BD1053a50430f4f…
2023-01-26 05:58 UTC2023-01A080154-001BD13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A080154-001BD13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A080154-001BD1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A080154-001BD1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A080154-001BD1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A080154-001BD1a50c72e98297…

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PROPYLTHIOURACILPROPYLTHIOURACILBryant Ranch Prepacka032648a-a6e4-4356-a483-8eee037790302025-11-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 080154
application number: ANDA080154
PROPYLTHIOURACILPROPYLTHIOURACILBryant Ranch Prepackae65e8b0-91b2-4a3f-8e1a-279e47eee9512024-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 080154
application number: ANDA080154
PROPYLTHIOURACILPROPYLTHIOURACILQUAGEN PHARMACEUTICALS LLC84eae11a-b572-4570-b288-ac2cdd3741862023-02-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 080154
application number: ANDA080154

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