Home NDC 0178-0900 Thiola
Product NDC 0178-0900
11-digit product format 001780900
Labeler code 0178
Product ID 0178-0900_3fa3e01c-df25-ad5d-e063-6394a90accf7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name tiopronin
Dosage form TABLET, SUGAR COATED
Route ORAL
Labeler Mission Pharmacal Company
Application NDA019569
Marketing category NDA
Marketing start 1988-08-11
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 · 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 · 42 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 2026-08-18 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…2022-09-29 23:25 UTC 2022-09 N019569-001 THIOLA 100MG TABLET / ORAL AB RLD, RS 1988-08-11 e64feba35796…
Observed Orange Book normalized TE history# Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base Thiola
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 198287 Internal RxNorm lookup 207840 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 0178-0900-01 Thiola 100 in 1 BOTTLE TABLET, SUGAR COATED 100 6
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded TIOPRONIN ACTIVE INGREDIENT C5W04GO61S THIOLA (TIOPRONIN) TABLET, SUGAR COATED [MISSION PHARMACAL COMPANY] 1 TIOPRONIN ACTIVE MOIETY C5W04GO61S THIOLA (TIOPRONIN) TABLET, SUGAR COATED [MISSION PHARMACAL COMPANY] 1 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 THIOLA (TIOPRONIN) TABLET, SUGAR COATED [MISSION PHARMACAL COMPANY] 1 CALCIUM CARBONATE INACTIVE INGREDIENT H0G9379FGK THIOLA (TIOPRONIN) TABLET, SUGAR COATED [MISSION PHARMACAL COMPANY] 1 CARNAUBA WAX INACTIVE INGREDIENT R12CBM0EIZ THIOLA (TIOPRONIN) TABLET, SUGAR COATED [MISSION PHARMACAL COMPANY] 1 DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER INACTIVE INGREDIENT 905HNO1SIH THIOLA (TIOPRONIN) TABLET, SUGAR COATED [MISSION PHARMACAL COMPANY] 1 ETHYLCELLULOSES INACTIVE INGREDIENT 7Z8S9VYZ4B THIOLA (TIOPRONIN) TABLET, SUGAR COATED [MISSION PHARMACAL COMPANY] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA THIOLA (TIOPRONIN) TABLET, SUGAR COATED [MISSION PHARMACAL COMPANY] 1 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P THIOLA (TIOPRONIN) TABLET, SUGAR COATED [MISSION PHARMACAL COMPANY] 1 LACTOSE INACTIVE INGREDIENT J2B2A4N98G THIOLA (TIOPRONIN) TABLET, SUGAR COATED [MISSION PHARMACAL COMPANY] 1 MAGNESIUM SILICATE INACTIVE INGREDIENT 9B9691B2N9 THIOLA (TIOPRONIN) TABLET, SUGAR COATED [MISSION PHARMACAL COMPANY] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 THIOLA (TIOPRONIN) TABLET, SUGAR COATED [MISSION PHARMACAL COMPANY] 1 POVIDONES INACTIVE INGREDIENT FZ989GH94E THIOLA (TIOPRONIN) TABLET, SUGAR COATED [MISSION PHARMACAL COMPANY] 1 SUCROSE INACTIVE INGREDIENT C151H8M554 THIOLA (TIOPRONIN) TABLET, SUGAR COATED [MISSION PHARMACAL COMPANY] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP THIOLA (TIOPRONIN) TABLET, SUGAR COATED [MISSION PHARMACAL COMPANY] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0178-0900 THIOLA (TIOPRONIN) TABLET, SUGAR COATED [MISSION PHARMACAL COMPANY] 5 Current NDC, Legacy NDC, 1 package rows 20240110_494a714e-923c-cd57-df6c-12886afb265a.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 Marketing end Sample Exclude flag Status 0178-0900-01 00178090001 100 TABLET, SUGAR COATED in 1 BOTTLE (0178-0900-01) 1988-08-11 0000-00-00 No No Current