Home NDC 0480-9227 Tiopronin
Product NDC 0480-9227
11-digit product format 004809227
Labeler code 0480
Product ID 0480-9227_53891a64-8014-4b0b-9f13-cfc3d90166b2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tiopronin
Dosage form TABLET, DELAYED RELEASE
Route ORAL
Labeler Teva Pharmaceuticals, Inc.
Application ANDA216456
Marketing category ANDA
Marketing start 2024-10-08
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 42 .
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 A216456-001 TIOPRONIN TIOPRONIN 100MG TABLET, DELAYED RELEASE / ORAL AB 2024-07-22 A216456-002 TIOPRONIN TIOPRONIN 300MG TABLET, DELAYED RELEASE / ORAL AB 2024-07-22
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 2026-08-18 06:07:40 2026-07 A216456-001 TIOPRONIN 100MG TABLET, DELAYED RELEASE / ORAL AB 2024-07-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A216456-002 TIOPRONIN 300MG TABLET, DELAYED RELEASE / ORAL AB 2024-07-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A216456-001 TIOPRONIN 100MG TABLET, DELAYED RELEASE / ORAL AB 2024-07-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216456-002 TIOPRONIN 300MG TABLET, DELAYED RELEASE / ORAL AB 2024-07-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216456-001 TIOPRONIN 100MG TABLET, DELAYED RELEASE / ORAL AB 2024-07-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216456-002 TIOPRONIN 300MG TABLET, DELAYED RELEASE / ORAL AB 2024-07-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216456-001 TIOPRONIN 100MG TABLET, DELAYED RELEASE / ORAL AB 2024-07-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216456-002 TIOPRONIN 300MG TABLET, DELAYED RELEASE / ORAL AB 2024-07-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216456-001 TIOPRONIN 100MG TABLET, DELAYED RELEASE / ORAL AB 2024-07-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216456-002 TIOPRONIN 300MG TABLET, DELAYED RELEASE / ORAL AB 2024-07-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216456-001 TIOPRONIN 100MG TABLET, DELAYED RELEASE / ORAL AB 2024-07-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216456-002 TIOPRONIN 300MG TABLET, DELAYED RELEASE / ORAL AB 2024-07-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216456-001 TIOPRONIN 100MG TABLET, DELAYED RELEASE / ORAL AB 2024-07-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216456-002 TIOPRONIN 300MG TABLET, DELAYED RELEASE / ORAL AB 2024-07-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216456-001 TIOPRONIN 100MG TABLET, DELAYED RELEASE / ORAL AB 2024-07-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216456-002 TIOPRONIN 300MG TABLET, DELAYED RELEASE / ORAL AB 2024-07-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216456-001 TIOPRONIN 100MG TABLET, DELAYED RELEASE / ORAL AB 2024-07-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216456-002 TIOPRONIN 300MG TABLET, DELAYED RELEASE / ORAL AB 2024-07-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216456-001 TIOPRONIN 100MG TABLET, DELAYED RELEASE / ORAL AB 2024-07-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216456-002 TIOPRONIN 300MG TABLET, DELAYED RELEASE / ORAL AB 2024-07-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216456-001 TIOPRONIN 100MG TABLET, DELAYED RELEASE / ORAL AB 2024-07-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A216456-002 TIOPRONIN 300MG TABLET, DELAYED RELEASE / ORAL AB 2024-07-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216456-001 TIOPRONIN 100MG TABLET, DELAYED RELEASE / ORAL AB 2024-07-22 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216456-002 TIOPRONIN 300MG TABLET, DELAYED RELEASE / ORAL AB 2024-07-22 79d66fd596c7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216456-001 TIOPRONIN 100MG TABLET, DELAYED RELEASE / ORAL AB 2024-07-22 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216456-002 TIOPRONIN 300MG TABLET, DELAYED RELEASE / ORAL AB 2024-07-22 a50c72e98297…
Observed Orange Book normalized TE history# 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 0480-9227-55 Tiopronin 300 in 1 BOTTLE TABLET, DELAYED RELEASE 300 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0480-9227 TIOPRONIN TABLET, DELAYED RELEASE [TEVA PHARMACEUTICALS, INC.] 4 Current NDC, 1 package rows 20241011_749257d9-a519-4b10-9058-7fe3f301cdd2.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 0480-9227-55 00480922755 300 TABLET, DELAYED RELEASE in 1 BOTTLE (0480-9227-55) 2024-10-08 No No Current