Home NDC 70709-123 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 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A216990-001 VENXXIVA TIOPRONIN 100MG TABLET, DELAYED RELEASE / ORAL AB 2024-01-30 A216990-002 VENXXIVA TIOPRONIN 300MG TABLET, DELAYED RELEASE / ORAL AB 2024-01-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 A216990-001 VENXXIVA 100MG TABLET, DELAYED RELEASE / ORAL AB 2024-01-30 a50c72e98297…2026-08-01 22:54:32 2026-06 A216990-002 VENXXIVA 300MG TABLET, DELAYED RELEASE / ORAL AB 2024-01-30 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 A216990-001 AB 1 a50c72e98297…2026-08-01 22:54:32 2026-06 A216990-002 AB 1 a50c72e98297…
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.
Additional Listing Data#
Finished product Yes
Brand name base VENXXIVA
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TIOPRONIN 300 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination C5W04GO61S Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2178075 Internal RxNorm lookup 2178079 Internal RxNorm lookup 2702682 Internal RxNorm lookup 2702684 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70709-123-90 VENXXIVA 90 in 1 BOTTLE TABLET, DELAYED RELEASE 90 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70709-123 VENXXIVA (TIOPRONIN) TABLET, DELAYED RELEASE [CYCLE PHARMACEUTICALS LTD.] 1 Current NDC, 1 package rows 20250122_02e24443-04c6-4b98-a395-49aec4a468de.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 70709-123-90 70709012390 90 TABLET, DELAYED RELEASE in 1 BOTTLE (70709-123-90) 2025-01-22 No No Current