Thiola EC

Product NDC
0178-0901
11-digit product format
001780901
Labeler code
0178
Product ID
0178-0901_4098f871-874f-92ec-e063-6394a90af53f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tiopronin
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Mission Pharmacal Company
Application
NDA211843
Marketing category
NDA
Marketing start
2019-06-28
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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TIOPRONIN300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiC5W04GO61S
Rxcui2178075, 2178077, 2178079, 2178081

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
0178-0901-90Thiola EC90 in 1 BOTTLETABLET, DELAYED RELEASE906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0178-0901-90EA - Each0178-090145b3f91d-bba2-4f47-96de-31af9693004b12019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0178-0901THIOLA EC (TIOPRONIN) TABLET, DELAYED RELEASE [MISSION PHARMACAL COMPANY]4Current NDC, Legacy NDC, 1 package rows20240110_20298a52-a194-a161-8632-d84b6f26e23c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2178077THIOLA EC 100 MG Delayed Release Oral TabletPSN20298a52-a194-a161-8632-d84b6f26e23c6
2178081THIOLA EC 300 MG Delayed Release Oral TabletPSN20298a52-a194-a161-8632-d84b6f26e23c6
2178075tiopronin 100 MG Delayed Release Oral TabletPSN20298a52-a194-a161-8632-d84b6f26e23c6
2178079tiopronin 300 MG Delayed Release Oral TabletPSN20298a52-a194-a161-8632-d84b6f26e23c6
2178077tiopronin 100 MG Delayed Release Oral Tablet [Thiola]SBD20298a52-a194-a161-8632-d84b6f26e23c6
2178081tiopronin 300 MG Delayed Release Oral Tablet [Thiola]SBD20298a52-a194-a161-8632-d84b6f26e23c6
2178075tiopronin 100 MG Delayed Release Oral TabletSCD20298a52-a194-a161-8632-d84b6f26e23c6
2178079tiopronin 300 MG Delayed Release Oral TabletSCD20298a52-a194-a161-8632-d84b6f26e23c6
2178077Thiola 100 MG Delayed Release Oral TabletSY20298a52-a194-a161-8632-d84b6f26e23c6
2178081Thiola 300 MG Delayed Release Oral TabletSY20298a52-a194-a161-8632-d84b6f26e23c6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0178-0901-900017809019090 TABLET, DELAYED RELEASE in 1 BOTTLE (0178-0901-90) 2019-06-280000-00-00NoNoCurrent