TIOPRONIN

Product NDC
13668-692
11-digit product format
136680692
Labeler code
13668
Product ID
13668-692_b56545da-a8ae-437a-9757-44862a6d95f0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tiopronin
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Torrent Pharmaceuticals Limited
Application
ANDA216990
Marketing category
ANDA
Marketing start
2024-01-30
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
TIOPRONIN
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TIOPRONIN300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiC5W04GO61S
Rxcui2178075, 2178079

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
13668-692-90TIOPRONIN90 in 1 BOTTLETABLET, DELAYED RELEASE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13668-692-90EA - Each13668-692125f20c3-efc7-4dcb-823e-96292448862a12024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13668-692TIOPRONIN TABLET, DELAYED RELEASE [TORRENT PHARMACEUTICALS LIMITED]2Current NDC, 1 package rows20241103_ad750031-08ec-4d92-af2d-97a80c454e14.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2178075tiopronin 100 MG Delayed Release Oral TabletPSNad750031-08ec-4d92-af2d-97a80c454e142
2178079tiopronin 300 MG Delayed Release Oral TabletPSNad750031-08ec-4d92-af2d-97a80c454e142
2178075tiopronin 100 MG Delayed Release Oral TabletSCDad750031-08ec-4d92-af2d-97a80c454e142
2178079tiopronin 300 MG Delayed Release Oral TabletSCDad750031-08ec-4d92-af2d-97a80c454e142

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
13668-692-901366806929090 TABLET, DELAYED RELEASE in 1 BOTTLE (13668-692-90) 2024-01-30NoNoCurrent