Home NDC 50742-354 MESNA
Product NDC 50742-354
11-digit product format 507420354
Labeler code 50742
Product ID 50742-354_ea85fa84-18f7-4b89-b701-1d9dc01a8e0d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name MESNA
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Ingenus Pharmaceuticals, LLC
Application ANDA218871
Marketing category ANDA
Marketing start 2025-01-14
Substance MESNA
Active strength 400 mg/1
Pharmacologic classes Cytoprotective Agent [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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A218871-001 MESNA MESNA 400MG TABLET / ORAL AB 2025-01-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A218871-001 AB
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 A218871-001 MESNA 400MG TABLET / ORAL AB 2025-01-13 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 A218871-001 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 · 1 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base MESNA
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MESNA 400 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination NR7O1405Q9 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 142113 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 50742-354-01 MESNA 10 in 1 BLISTER PACK TABLET, FILM COATED 10 2 50742-354-01 MESNA 1 in 1 CARTON TABLET, FILM COATED 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50742-354 MESNA TABLET, FILM COATED [INGENUS PHARMACEUTICALS, LLC] 2 Current NDC, 2 package rows 20250117_90d64539-33ad-47e8-9de7-17d6c5baaba4.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 50742-354-01 50742035401 1 BLISTER PACK in 1 CARTON (50742-354-01) / 10 TABLET, FILM COATED in 1 BLISTER PACK 1 blister pack 2025-01-14 No No Current