Home NDC 0228-2348 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 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A080172-001 PROPYLTHIOURACIL PROPYLTHIOURACIL 50MG TABLET / ORAL BD Approved before 1982
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A080172-001 BD
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A080172-001 PROPYLTHIOURACIL 50MG TABLET / ORAL BD Approved before 1982 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A080172-001 PROPYLTHIOURACIL 50MG TABLET / ORAL BD Approved before 1982 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A080172-001 PROPYLTHIOURACIL 50MG TABLET / ORAL BD Approved before 1982 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A080172-001 PROPYLTHIOURACIL 50MG TABLET / ORAL BD Approved before 1982 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A080172-001 PROPYLTHIOURACIL 50MG TABLET / ORAL BD Approved before 1982 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A080172-001 PROPYLTHIOURACIL 50MG TABLET / ORAL BD Approved before 1982 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A080172-001 PROPYLTHIOURACIL 50MG TABLET / ORAL BD Approved before 1982 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A080172-001 PROPYLTHIOURACIL 50MG TABLET / ORAL BD Approved before 1982 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A080172-001 PROPYLTHIOURACIL 50MG TABLET / ORAL BD Approved before 1982 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A080172-001 PROPYLTHIOURACIL 50MG TABLET / ORAL BD Approved before 1982 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A080172-001 PROPYLTHIOURACIL 50MG TABLET / ORAL BD Approved before 1982 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A080172-001 PROPYLTHIOURACIL 50MG TABLET / ORAL BD Approved before 1982 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A080172-001 PROPYLTHIOURACIL 50MG TABLET / ORAL BD Approved before 1982 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A080172-001 PROPYLTHIOURACIL 50MG TABLET / ORAL BD Approved before 1982 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A080172-001 PROPYLTHIOURACIL 50MG TABLET / ORAL BD Approved before 1982 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A080172-001 PROPYLTHIOURACIL 50MG TABLET / ORAL BD Approved before 1982 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A080172-001 PROPYLTHIOURACIL 50MG TABLET / ORAL BD Approved before 1982 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A080172-001 PROPYLTHIOURACIL 50MG TABLET / ORAL BD Approved before 1982 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A080172-001 PROPYLTHIOURACIL 50MG TABLET / ORAL BD Approved before 1982 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A080172-001 PROPYLTHIOURACIL 50MG TABLET / ORAL BD Approved before 1982 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A080172-001 PROPYLTHIOURACIL 50MG TABLET / ORAL BD Approved before 1982 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A080172-001 PROPYLTHIOURACIL 50MG TABLET / ORAL BD Approved before 1982 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A080172-001 PROPYLTHIOURACIL 50MG TABLET / ORAL BD Approved before 1982 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A080172-001 PROPYLTHIOURACIL 50MG TABLET / ORAL BD Approved before 1982 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A080172-001 PROPYLTHIOURACIL 50MG TABLET / ORAL BD Approved before 1982 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A080172-001 PROPYLTHIOURACIL 50MG TABLET / ORAL BD Approved before 1982 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A080172-001 PROPYLTHIOURACIL 50MG TABLET / ORAL BD Approved before 1982 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A080172-001 PROPYLTHIOURACIL 50MG TABLET / ORAL BD Approved before 1982 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A080172-001 PROPYLTHIOURACIL 50MG TABLET / ORAL BD Approved before 1982 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A080172-001 PROPYLTHIOURACIL 50MG TABLET / ORAL BD Approved before 1982 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A080172-001 PROPYLTHIOURACIL 50MG TABLET / ORAL BD Approved before 1982 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A080172-001 PROPYLTHIOURACIL 50MG TABLET / ORAL BD Approved before 1982 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A080172-001 PROPYLTHIOURACIL 50MG TABLET / ORAL BD Approved before 1982 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A080172-001 PROPYLTHIOURACIL 50MG TABLET / ORAL BD Approved before 1982 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A080172-001 PROPYLTHIOURACIL 50MG TABLET / ORAL BD Approved before 1982 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A080172-001 PROPYLTHIOURACIL 50MG TABLET / ORAL BD Approved before 1982 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A080172-001 PROPYLTHIOURACIL 50MG TABLET / ORAL BD Approved before 1982 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A080172-001 PROPYLTHIOURACIL 50MG TABLET / ORAL BD Approved before 1982 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A080172-001 PROPYLTHIOURACIL 50MG TABLET / ORAL BD Approved before 1982 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A080172-001 PROPYLTHIOURACIL 50MG TABLET / ORAL BD Approved before 1982 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded PROPYLTHIOURACIL ACTIVE INGREDIENT 721M9407IY PROPYLTHIOURACIL TABLET [ACTAVIS ELIZABETH LLC] 6 PROPYLTHIOURACIL ACTIVE MOIETY 721M9407IY PROPYLTHIOURACIL TABLET [ACTAVIS ELIZABETH LLC] 6 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X PROPYLTHIOURACIL TABLET [ACTAVIS ELIZABETH LLC] 6 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 PROPYLTHIOURACIL TABLET [ACTAVIS ELIZABETH LLC] 6 POVIDONE INACTIVE INGREDIENT FZ989GH94E PROPYLTHIOURACIL TABLET [ACTAVIS ELIZABETH LLC] 6 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 PROPYLTHIOURACIL TABLET [ACTAVIS ELIZABETH LLC] 6 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ PROPYLTHIOURACIL TABLET [ACTAVIS ELIZABETH LLC] 6 PROPYLTHIOURACIL ACTIVE INGREDIENT 721M9407IY PROPYLTHIOURACIL TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 1 PROPYLTHIOURACIL ACTIVE MOIETY 721M9407IY PROPYLTHIOURACIL TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 1 COLLOIDAL SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 PROPYLTHIOURACIL TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X PROPYLTHIOURACIL TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 PROPYLTHIOURACIL TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 1 POVIDONE INACTIVE INGREDIENT FZ989GH94E PROPYLTHIOURACIL TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ PROPYLTHIOURACIL TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0228-2348 PROPYLTHIOURACIL TABLET [ACTAVIS PHARMA, INC.] 22 Legacy NDC 20240721_a57c49ae-d659-49fa-84e3-cf6d1f9e6f97.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 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0228-2348-10 00228234810 100 TABLET in 1 BOTTLE (0228-2348-10) 100 tablet 2006-01-15 0000-00-00 No No Current