FDA.reportPublic FDA data

VENXXIVA

Product NDC
70709-123
11-digit product format
707090123
Labeler code
70709
Product ID
70709-123_c8eeb4d4-9718-41ba-b4fe-3d645fd60a20
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tiopronin
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Cycle Pharmaceuticals Ltd.
Application
ANDA216990
Marketing category
ANDA
Marketing start
2025-01-22
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
VENXXIVA
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TIOPRONIN300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiC5W04GO61S
Rxcui2178075, 2178079, 2702682, 2702684

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
19fd197c-a0a2-47ec-a473-bf965abd1795Product name220250429
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
a6c2b4b8-5194-92f1-e438-706fc5c2e8b4Product name320230303

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70709-123-90VENXXIVA90 in 1 BOTTLETABLET, DELAYED RELEASE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70709-123-90EA - Each70709-1236eac269d-deae-43ef-9384-c28601d4231b12025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70709-123VENXXIVA (TIOPRONIN) TABLET, DELAYED RELEASE [CYCLE PHARMACEUTICALS LTD.]1Current NDC, 1 package rows20250122_02e24443-04c6-4b98-a395-49aec4a468de.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2178075tiopronin 100 MG Delayed Release Oral TabletPSN02e24443-04c6-4b98-a395-49aec4a468de2
2178079tiopronin 300 MG Delayed Release Oral TabletPSN02e24443-04c6-4b98-a395-49aec4a468de2
2702682VENXXIVA 100 MG Delayed Release Oral TabletPSN02e24443-04c6-4b98-a395-49aec4a468de2
2702684VENXXIVA 300 MG Delayed Release Oral TabletPSN02e24443-04c6-4b98-a395-49aec4a468de2
2702682tiopronin 100 MG Delayed Release Oral Tablet [Venxxiva]SBD02e24443-04c6-4b98-a395-49aec4a468de2
2702684tiopronin 300 MG Delayed Release Oral Tablet [Venxxiva]SBD02e24443-04c6-4b98-a395-49aec4a468de2
2178075tiopronin 100 MG Delayed Release Oral TabletSCD02e24443-04c6-4b98-a395-49aec4a468de2
2178079tiopronin 300 MG Delayed Release Oral TabletSCD02e24443-04c6-4b98-a395-49aec4a468de2
2702682Venxxiva 100 MG Delayed Release Oral TabletSY02e24443-04c6-4b98-a395-49aec4a468de2
2702684Venxxiva 300 MG Delayed Release Oral TabletSY02e24443-04c6-4b98-a395-49aec4a468de2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70709-123-907070901239090 TABLET, DELAYED RELEASE in 1 BOTTLE (70709-123-90) 2025-01-22NoNoCurrent