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 1 .
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.
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 N019569-001 THIOLA 100MG TABLET / ORAL AB RLD, RS 1988-08-11 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 N019569-001 AB 1 a50c72e98297…
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2026-08-01 22:54:32 2026-06 N019569-001 ODE-267 2026-06-28 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 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
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