Home NDC 60219-2009 tiopronin
Product NDC 60219-2009
11-digit product format 602192009
Labeler code 60219
Product ID 60219-2009_98b9196d-4cc8-4ffe-8a45-8bced8f4284f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name tiopronin
Dosage form TABLET, DELAYED RELEASE
Route ORAL
Labeler Amneal Pharmaceuticals NY LLC
Application ANDA216278
Marketing category ANDA
Marketing start 2025-01-02
Substance TIOPRONIN
Active strength 300 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 A216278-001 TIOPRONIN TIOPRONIN 300MG TABLET, DELAYED RELEASE / ORAL 2023-08-15 A216278-002 TIOPRONIN TIOPRONIN 100MG TABLET, DELAYED RELEASE / ORAL 2025-08-29
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 A216278-001 TIOPRONIN 300MG TABLET, DELAYED RELEASE / ORAL 2023-08-15 a50c72e98297…2026-08-01 22:54:32 2026-06 A216278-002 TIOPRONIN 100MG TABLET, DELAYED RELEASE / ORAL 2025-08-29 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 300 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 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 60219-2009-9 tiopronin 90 in 1 BOTTLE TABLET, DELAYED RELEASE 90 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60219-2009 TIOPRONIN TABLET, DELAYED RELEASE [AMNEAL PHARMACEUTICALS NY LLC] 6 Current NDC, 1 package rows 20230819_ce5b1f97-5b3c-40b6-b1c4-1d36025be1b8.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 60219-2009-9 60219200909 90 TABLET, DELAYED RELEASE in 1 BOTTLE (60219-2009-9) 2025-01-02 No No Current