FDA.reportPublic FDA data

Tiopronin

Product NDC
0093-7909
11-digit product format
000937909
Labeler code
0093
Product ID
0093-7909_f2fc3b85-ad95-4e79-b523-5dab8ff96c96
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tiopronin
Dosage form
TABLET, SUGAR COATED
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA214326
Marketing category
ANDA
Marketing start
2021-05-17
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

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
unfinished productproduct0093-7909UNFINISHEDActive or certified unfinished drug listing2026-07-31
unfinished packagepackage0093-79090093-7909-00UNFINISHEDActive or certified unfinished drug listing2026-07-31

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A214326-001TIOPRONINTIOPRONIN100MGTABLET / ORALAB2021-04-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A214326-001AB

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 22:54:322026-06A214326-001TIOPRONIN100MGTABLET / ORALAB2021-04-26a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A214326-001AB1a50c72e98297…

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TioproninTIOPRONINTeva Pharmaceuticals USA, Inc.8dee6eff-0ec1-4fe7-8d27-18cdc6cf54b92025-04-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214326
application number: ANDA214326
ndc (product): 0093-7909

Additional Listing Data#

Finished product
Yes
Brand name base
Tiopronin
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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198287Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
8dee6eff-0ec1-4fe7-8d27-18cdc6cf54b9Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
19fd197c-a0a2-47ec-a473-bf965abd1795Product name220250429
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
a6c2b4b8-5194-92f1-e438-706fc5c2e8b4Product name320230303
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0093-7909-01Tiopronin100 in 1 BOTTLETABLET, SUGAR COATED1004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-7909-01EA - Each0093-790968a8b040-ab4f-4911-a505-31a5196c2ec812021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0093-7909TIOPRONIN TABLET, SUGAR COATED [TEVA PHARMACEUTICALS USA, INC.]4Current NDC, Legacy NDC, 1 package rows20250416_8dee6eff-0ec1-4fe7-8d27-18cdc6cf54b9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198287tiopronin 100 MG Oral TabletPSN8dee6eff-0ec1-4fe7-8d27-18cdc6cf54b94
198287tiopronin 100 MG Oral TabletSCD8dee6eff-0ec1-4fe7-8d27-18cdc6cf54b94

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0093-7909-000009379090027778 TABLET, SUGAR COATED in 1 BOX (0093-7909-00)02-JUL-21Current
0093-7909-0100093790901100 TABLET, SUGAR COATED in 1 BOTTLE (0093-7909-01) 2021-05-170000-00-00NoNoCurrent