FDA.reportPublic FDA data

Thiola EC

Product NDC
0178-0902
11-digit product format
001780902
Labeler code
0178
Product ID
0178-0902_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
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N211843-001THIOLA ECTIOPRONIN100MGTABLET, DELAYED RELEASE / ORALABRLD2019-06-28
N211843-002THIOLA ECTIOPRONIN300MGTABLET, DELAYED RELEASE / ORALABRLD, RS2019-06-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
N211843-001AB
N211843-002AB

Orange Book patents#

Current patent rows page 1 of 1 · 2 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N211843-001114581042038-11-14U-34412022-10-06
N211843-002114581042038-11-14U-34412022-10-06

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 2 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N211843-001ODE*2026-06-28
N211843-002ODE*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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N211843-001THIOLA EC100MGTABLET, DELAYED RELEASE / ORALABRLD2019-06-28a50c72e98297…
2026-08-01 22:54:322026-06N211843-002THIOLA EC300MGTABLET, DELAYED RELEASE / ORALABRLD, RS2019-06-28a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06N211843-001AB1a50c72e98297…
2026-08-01 22:54:322026-06N211843-002AB1a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-01 22:54:322026-06N211843-001114581042038-11-14U-34412022-10-06a50c72e98297…
2026-08-01 22:54:322026-06N211843-002114581042038-11-14U-34412022-10-06a50c72e98297…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-08-01 22:54:322026-06N211843-001ODE*2026-06-28a50c72e98297…
2026-08-01 22:54:322026-06N211843-002ODE*2026-06-28a50c72e98297…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Thiola ECTIOPRONINMission Pharmacal Company20298a52-a194-a161-8632-d84b6f26e23c2025-10-07Warnings, Adverse reactionsExact identifier
application applno (NDA): 211843
application number: NDA211843
ndc (product): 0178-0902
TioproninTIOPRONINBioComp Pharma, Inc.1f2eb1d6-faa6-e352-e063-6294a90a7fb52025-06-05Warnings, Adverse reactionsExact identifier
application applno (NDA): 211843
application number: NDA211843

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TIOPRONIN100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
C5W04GO61SInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2178075Internal RxNorm lookup
2178077Internal RxNorm lookup
2178079Internal RxNorm lookup
2178081Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
20298a52-a194-a161-8632-d84b6f26e23cAvailable on FDA.report

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
0178-0902-01Thiola EC300 in 1 BOTTLETABLET, DELAYED RELEASE3006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0178-0902-01EA - Each0178-0902164e028d-6916-4e71-b71a-9f7ff9ddfd0b12019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0178-0902THIOLA 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
0178-0902-0100178090201300 TABLET, DELAYED RELEASE in 1 BOTTLE (0178-0902-01) 2019-06-280000-00-00NoNoCurrent