FDA.reportPublic FDA data

Tiopronin

Product NDC
44523-055
11-digit product format
445230055
Labeler code
44523
Product ID
44523-055_36d7fad3-57c6-67e7-e063-6294a90ad7b5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tiopronin
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
BioComp Pharma, Inc.
Application
NDA211843
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2024-12-05
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

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
TioproninTIOPRONINBioComp Pharma, Inc.1f2eb1d6-faa6-e352-e063-6294a90a7fb52025-06-05Warnings, Adverse reactionsExact identifier
application applno (NDA): 211843
application number: NDA211843
ndc (product): 44523-055

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TIOPRONIN300 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 · 2 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1f2eb1d6-faa6-e352-e063-6294a90a7fb5Available 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
44523-055-01Tiopronin90 in 1 BOTTLETABLET, DELAYED RELEASE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
44523-055-01EA - Each44523-055f3393895-a3e8-4cbc-ba5d-da49b6b852c312025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44523-055TIOPRONIN TABLET, DELAYED RELEASE [BIO COMP PHARMA, INC.]1Current NDC, 1 package rows20241208_1f2eb1d6-faa6-e352-e063-6294a90a7fb5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2178075tiopronin 100 MG Delayed Release Oral TabletPSN1f2eb1d6-faa6-e352-e063-6294a90a7fb52
2178079tiopronin 300 MG Delayed Release Oral TabletPSN1f2eb1d6-faa6-e352-e063-6294a90a7fb52
2178075tiopronin 100 MG Delayed Release Oral TabletSCD1f2eb1d6-faa6-e352-e063-6294a90a7fb52
2178079tiopronin 300 MG Delayed Release Oral TabletSCD1f2eb1d6-faa6-e352-e063-6294a90a7fb52

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
44523-055-014452300550190 TABLET, DELAYED RELEASE in 1 BOTTLE (44523-055-01) 2024-12-05NoNoCurrent