Home NDC 13668-691 TIOPRONIN
Product NDC 13668-691
11-digit product format 136680691
Labeler code 13668
Product ID 13668-691_b56545da-a8ae-437a-9757-44862a6d95f0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name tiopronin
Dosage form TABLET, DELAYED RELEASE
Route ORAL
Labeler Torrent Pharmaceuticals Limited
Application ANDA216990
Marketing category ANDA
Marketing start 2024-01-30
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 A216990-001 VENXXIVA TIOPRONIN 100MG TABLET, DELAYED RELEASE / ORAL AB 2024-01-30 A216990-002 VENXXIVA TIOPRONIN 300MG TABLET, DELAYED RELEASE / ORAL AB 2024-01-30
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 2024-11-08 22:44 UTC · 2 captures of this ZIP 2024-11 A216990-001 TIOPRONIN 100MG TABLET, DELAYED RELEASE / ORAL AB 2024-01-30 d8e5a09893c0…2024-11-08 22:44 UTC · 2 captures of this ZIP 2024-11 A216990-002 TIOPRONIN 300MG TABLET, DELAYED RELEASE / ORAL AB 2024-01-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216990-001 TIOPRONIN 100MG TABLET, DELAYED RELEASE / ORAL AB 2024-01-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A216990-002 TIOPRONIN 300MG TABLET, DELAYED RELEASE / ORAL AB 2024-01-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216990-001 TIOPRONIN 100MG TABLET, DELAYED RELEASE / ORAL AB 2024-01-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216990-002 TIOPRONIN 300MG TABLET, DELAYED RELEASE / ORAL AB 2024-01-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216990-001 TIOPRONIN 100MG TABLET, DELAYED RELEASE / ORAL AB 2024-01-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216990-002 TIOPRONIN 300MG TABLET, DELAYED RELEASE / ORAL AB 2024-01-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216990-001 TIOPRONIN 100MG TABLET, DELAYED RELEASE / ORAL AB 2024-01-30 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216990-002 TIOPRONIN 300MG TABLET, DELAYED RELEASE / ORAL AB 2024-01-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A216990-001 TIOPRONIN 100MG TABLET, DELAYED RELEASE / ORAL AB 2024-01-30 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A216990-002 TIOPRONIN 300MG TABLET, DELAYED RELEASE / ORAL AB 2024-01-30 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216990-001 TIOPRONIN 100MG TABLET, DELAYED RELEASE / ORAL AB 2024-01-30 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216990-002 TIOPRONIN 300MG TABLET, DELAYED RELEASE / ORAL AB 2024-01-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A216990-001 TIOPRONIN 100MG TABLET, DELAYED RELEASE / ORAL AB 2024-01-30 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A216990-002 TIOPRONIN 300MG TABLET, DELAYED RELEASE / ORAL AB 2024-01-30 1c564ffb4f44…2026-08-01 22:54:32 2026-06 A216990-001 VENXXIVA 100MG TABLET, DELAYED RELEASE / ORAL AB 2024-01-30 a50c72e98297…2026-08-01 22:54:32 2026-06 A216990-002 VENXXIVA 300MG TABLET, DELAYED RELEASE / ORAL AB 2024-01-30 a50c72e98297…
Observed Orange Book normalized TE history# 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 · 2 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 13668-691-03 TIOPRONIN 300 in 1 BOTTLE TABLET, DELAYED RELEASE 300 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 13668-691 TIOPRONIN TABLET, DELAYED RELEASE [TORRENT PHARMACEUTICALS LIMITED] 2 Current NDC, 1 package rows 20241103_ad750031-08ec-4d92-af2d-97a80c454e14.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 13668-691-03 13668069103 300 TABLET, DELAYED RELEASE in 1 BOTTLE (13668-691-03) 2024-01-30 No No Current