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 42 .
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 2026-08-18 06:07:40 2026-07 A218871-001 MESNA 400MG TABLET / ORAL AB 2025-01-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A218871-001 MESNA 400MG TABLET / ORAL AB 2025-01-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218871-001 MESNA 400MG TABLET / ORAL AB 2025-01-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A218871-001 MESNA 400MG TABLET / ORAL AB 2025-01-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218871-001 MESNA 400MG TABLET / ORAL AB 2025-01-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218871-001 MESNA 400MG TABLET / ORAL AB 2025-01-13 b8a1b40f171c…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218871-001 MESNA 400MG TABLET / ORAL AB 2025-01-13 a50c72e98297…
Observed Orange Book normalized TE history# Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218871-001 CGT 2025-07-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A218871-001 CGT 2025-07-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218871-001 CGT 2025-07-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218871-001 CGT 2025-07-13 b8a1b40f171c…
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
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
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