Home NDC 44523-053 Tiopronin
Product NDC 44523-053
11-digit product format 445230053
Labeler code 44523
Product ID 44523-053_59e06801-0ef4-29f2-e063-6294a90a4368
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tiopronin
Dosage form TABLET, SUGAR COATED
Route ORAL
Labeler BioComp Pharma, Inc.
Application NDA019569
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2026-09-01
Substance TIOPRONIN
Active strength 100 mg/1
Pharmacologic classes Cystine Disulfide Reduction [MoA], N-substituted Glycines [CS], Reducing and Complexing Thiol [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 N019569-001 THIOLA TIOPRONIN 100MG TABLET / ORAL AB RLD, RS 1988-08-11
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N019569-001 AB
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N019569-001 ODE-267 2026-06-28
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 · 43 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 2026-09-14 22:38:34 2026-08 N019569-001 THIOLA 100MG TABLET / ORAL AB RLD, RS 1988-08-11 84e616aacf4f…2026-08-18 06:07:40 2026-07 N019569-001 THIOLA 100MG TABLET / ORAL AB RLD, RS 1988-08-11 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N019569-001 THIOLA 100MG TABLET / ORAL AB RLD, RS 1988-08-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019569-001 THIOLA 100MG TABLET / ORAL AB RLD, RS 1988-08-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N019569-001 THIOLA 100MG TABLET / ORAL AB RLD, RS 1988-08-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019569-001 THIOLA 100MG TABLET / ORAL AB RLD, RS 1988-08-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019569-001 THIOLA 100MG TABLET / ORAL AB RLD, RS 1988-08-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019569-001 THIOLA 100MG TABLET / ORAL AB RLD, RS 1988-08-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019569-001 THIOLA 100MG TABLET / ORAL AB RLD, RS 1988-08-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019569-001 THIOLA 100MG TABLET / ORAL AB RLD, RS 1988-08-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019569-001 THIOLA 100MG TABLET / ORAL AB RLD, RS 1988-08-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N019569-001 THIOLA 100MG TABLET / ORAL AB RLD, RS 1988-08-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019569-001 THIOLA 100MG TABLET / ORAL AB RLD, RS 1988-08-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019569-001 THIOLA 100MG TABLET / ORAL AB RLD, RS 1988-08-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N019569-001 THIOLA 100MG TABLET / ORAL AB RLD, RS 1988-08-11 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N019569-001 THIOLA 100MG TABLET / ORAL AB RLD, RS 1988-08-11 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N019569-001 THIOLA 100MG TABLET / ORAL AB RLD, RS 1988-08-11 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N019569-001 THIOLA 100MG TABLET / ORAL AB RLD, RS 1988-08-11 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N019569-001 THIOLA 100MG TABLET / ORAL AB RLD, RS 1988-08-11 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N019569-001 THIOLA 100MG TABLET / ORAL RLD, RS 1988-08-11 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N019569-001 THIOLA 100MG TABLET / ORAL AB RLD, RS 1988-08-11 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N019569-001 THIOLA 100MG TABLET / ORAL AB RLD, RS 1988-08-11 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N019569-001 THIOLA 100MG TABLET / ORAL RLD, RS 1988-08-11 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N019569-001 THIOLA 100MG TABLET / ORAL RLD, RS 1988-08-11 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N019569-001 THIOLA 100MG TABLET / ORAL RLD, RS 1988-08-11 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N019569-001 THIOLA 100MG TABLET / ORAL RLD, RS 1988-08-11 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N019569-001 THIOLA 100MG TABLET / ORAL RLD, RS 1988-08-11 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N019569-001 THIOLA 100MG TABLET / ORAL RLD, RS 1988-08-11 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N019569-001 THIOLA 100MG TABLET / ORAL RLD, RS 1988-08-11 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N019569-001 THIOLA 100MG TABLET / ORAL AB RLD, RS 1988-08-11 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N019569-001 THIOLA 100MG TABLET / ORAL AB RLD, RS 1988-08-11 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N019569-001 THIOLA 100MG TABLET / ORAL AB RLD, RS 1988-08-11 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N019569-001 THIOLA 100MG TABLET / ORAL AB RLD, RS 1988-08-11 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N019569-001 THIOLA 100MG TABLET / ORAL AB RLD, RS 1988-08-11 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N019569-001 THIOLA 100MG TABLET / ORAL AB RLD, RS 1988-08-11 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N019569-001 THIOLA 100MG TABLET / ORAL AB RLD, RS 1988-08-11 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N019569-001 THIOLA 100MG TABLET / ORAL AB RLD, RS 1988-08-11 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N019569-001 THIOLA 100MG TABLET / ORAL AB RLD, RS 1988-08-11 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N019569-001 THIOLA 100MG TABLET / ORAL AB RLD, RS 1988-08-11 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N019569-001 THIOLA 100MG TABLET / ORAL AB RLD, RS 1988-08-11 f41ea6bd6efb…
Observed Orange Book normalized TE history# Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 41 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Tiopronin
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TIOPRONIN 100 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination C5W04GO61S Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198287 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 · 2 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 44523-053-01 44523005301 100 TABLET, SUGAR COATED in 1 BOTTLE (44523-053-01) 2026-09-01 No No Current