Home NDC 0254-3034 TIOPRONIN
Product NDC 0254-3034
11-digit product format 002543034
Labeler code 0254
Product ID 0254-3034_44d74b79-7146-42ef-ace2-fa64cffeb041
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name TIOPRONIN
Dosage form TABLET, DELAYED RELEASE
Route ORAL
Labeler Endo USA, Inc.
Application ANDA217219
Marketing category ANDA
Marketing start 2024-06-26
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 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A217219-001 TIOPRONIN TIOPRONIN 100MG TABLET, DELAYED RELEASE / ORAL AB 2023-02-24 A217219-002 TIOPRONIN TIOPRONIN 300MG TABLET, DELAYED RELEASE / ORAL AB 2023-02-24
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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.
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 2026-08-01 22:54:32 2026-06 A217219-001 TIOPRONIN 100MG TABLET, DELAYED RELEASE / ORAL AB 2023-02-24 a50c72e98297…2026-08-01 22:54:32 2026-06 A217219-002 TIOPRONIN 300MG TABLET, DELAYED RELEASE / ORAL AB 2023-02-24 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 A217219-001 AB 1 a50c72e98297…2026-08-01 22:54:32 2026-06 A217219-002 AB 1 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base TIOPRONIN
Listing expiration 2026-12-31 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2178075 Internal RxNorm lookup 2178079 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0254-3034-30 TIOPRONIN 300 in 1 BOTTLE TABLET, DELAYED RELEASE 300 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0254-3034 TIOPRONIN TABLET, DELAYED RELEASE [ENDO USA, INC.] 7 Current NDC, 1 package rows 20250109_5396b9fd-5385-44fd-a8ba-e56a46a33bc7.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 0254-3034-30 00254303430 300 TABLET, DELAYED RELEASE in 1 BOTTLE (0254-3034-30) 2024-06-26 No No Current