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

Additional Listing Data#

Finished product
Yes
Brand name base
Thiola
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TIOPRONIN100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiC5W04GO61S
Rxcui198287, 207840

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
19fd197c-a0a2-47ec-a473-bf965abd1795Product name220250429
a6c2b4b8-5194-92f1-e438-706fc5c2e8b4Product name320230303

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0178-0900-01Thiola100 in 1 BOTTLETABLET, SUGAR COATED1006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0178-0900-01EA - Each0178-090014f2c04f-aeed-49cd-8d7a-b0b22efa6cf312013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TIOPRONINACTIVE INGREDIENTC5W04GO61STHIOLA (TIOPRONIN) TABLET, SUGAR COATED [MISSION PHARMACAL COMPANY]1
TIOPRONINACTIVE MOIETYC5W04GO61STHIOLA (TIOPRONIN) TABLET, SUGAR COATED [MISSION PHARMACAL COMPANY]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933THIOLA (TIOPRONIN) TABLET, SUGAR COATED [MISSION PHARMACAL COMPANY]1
CALCIUM CARBONATEINACTIVE INGREDIENTH0G9379FGKTHIOLA (TIOPRONIN) TABLET, SUGAR COATED [MISSION PHARMACAL COMPANY]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZTHIOLA (TIOPRONIN) TABLET, SUGAR COATED [MISSION PHARMACAL COMPANY]1
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMERINACTIVE INGREDIENT905HNO1SIHTHIOLA (TIOPRONIN) TABLET, SUGAR COATED [MISSION PHARMACAL COMPANY]1
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BTHIOLA (TIOPRONIN) TABLET, SUGAR COATED [MISSION PHARMACAL COMPANY]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOATHIOLA (TIOPRONIN) TABLET, SUGAR COATED [MISSION PHARMACAL COMPANY]1
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PTHIOLA (TIOPRONIN) TABLET, SUGAR COATED [MISSION PHARMACAL COMPANY]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GTHIOLA (TIOPRONIN) TABLET, SUGAR COATED [MISSION PHARMACAL COMPANY]1
MAGNESIUM SILICATEINACTIVE INGREDIENT9B9691B2N9THIOLA (TIOPRONIN) TABLET, SUGAR COATED [MISSION PHARMACAL COMPANY]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30THIOLA (TIOPRONIN) TABLET, SUGAR COATED [MISSION PHARMACAL COMPANY]1
POVIDONESINACTIVE INGREDIENTFZ989GH94ETHIOLA (TIOPRONIN) TABLET, SUGAR COATED [MISSION PHARMACAL COMPANY]1
SUCROSEINACTIVE INGREDIENTC151H8M554THIOLA (TIOPRONIN) TABLET, SUGAR COATED [MISSION PHARMACAL COMPANY]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTHIOLA (TIOPRONIN) TABLET, SUGAR COATED [MISSION PHARMACAL COMPANY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0178-0900THIOLA (TIOPRONIN) TABLET, SUGAR COATED [MISSION PHARMACAL COMPANY]5Current NDC, Legacy NDC, 1 package rows20240110_494a714e-923c-cd57-df6c-12886afb265a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
207840Thiola 100 MG Oral TabletPSN494a714e-923c-cd57-df6c-12886afb265a6
198287tiopronin 100 MG Oral TabletPSN494a714e-923c-cd57-df6c-12886afb265a6
207840tiopronin 100 MG Oral Tablet [Thiola]SBD494a714e-923c-cd57-df6c-12886afb265a6
198287tiopronin 100 MG Oral TabletSCD494a714e-923c-cd57-df6c-12886afb265a6
207840Thiola 100 MG Oral TabletSY494a714e-923c-cd57-df6c-12886afb265a6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0178-0900-0100178090001100 TABLET, SUGAR COATED in 1 BOTTLE (0178-0900-01) 1988-08-110000-00-00NoNoCurrent