Home NDC 67108-3565 MESNEX
Product NDC 67108-3565
11-digit product format 671083565
Labeler code 67108
Product ID 67108-3565_8ca1fcdb-9f06-4cc1-b48b-c2b3db4dc921
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name MESNA
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Baxter Healthcare Company
Application NDA020855
Marketing category NDA
Marketing start 2002-03-21
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 N020855-001 MESNEX MESNA 400MG TABLET / ORAL AB RLD, RS 2002-03-21
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N020855-001 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 N020855-001 MESNEX 400MG TABLET / ORAL AB RLD, RS 2002-03-21 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 N020855-001 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 MESNEX
Listing expiration 2027-12-31 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 142113 Internal RxNorm lookup 352210 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 67108-3565-9 MESNEX 1 in 1 BLISTER PACK TABLET, FILM COATED 1 16 67108-3565-9 MESNEX 10 in 1 CARTON TABLET, FILM COATED 10 16
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded MESNA ACTIVE INGREDIENT NR7O1405Q9 MESNEX (MESNA) TABLET, FILM COATED [BAXTER HEALTHCARE CORPORATION] 8 2-MERCAPTOETHANESULFONIC ACID ACTIVE MOIETY VHD28S0H7F MESNEX (MESNA) TABLET, FILM COATED [BAXTER HEALTHCARE CORPORATION] 8 CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE INACTIVE INGREDIENT O7TSZ97GEP MESNEX (MESNA) TABLET, FILM COATED [BAXTER HEALTHCARE CORPORATION] 8 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U MESNEX (MESNA) TABLET, FILM COATED [BAXTER HEALTHCARE CORPORATION] 8 DIMETHICONE INACTIVE INGREDIENT 92RU3N3Y1O MESNEX (MESNA) TABLET, FILM COATED [BAXTER HEALTHCARE CORPORATION] 8 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P MESNEX (MESNA) TABLET, FILM COATED [BAXTER HEALTHCARE CORPORATION] 8 LACTOSE INACTIVE INGREDIENT J2B2A4N98G MESNEX (MESNA) TABLET, FILM COATED [BAXTER HEALTHCARE CORPORATION] 8 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 MESNEX (MESNA) TABLET, FILM COATED [BAXTER HEALTHCARE CORPORATION] 8 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A MESNEX (MESNA) TABLET, FILM COATED [BAXTER HEALTHCARE CORPORATION] 8 POVIDONES INACTIVE INGREDIENT FZ989GH94E MESNEX (MESNA) TABLET, FILM COATED [BAXTER HEALTHCARE CORPORATION] 8 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ MESNEX (MESNA) TABLET, FILM COATED [BAXTER HEALTHCARE CORPORATION] 8 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP MESNEX (MESNA) TABLET, FILM COATED [BAXTER HEALTHCARE CORPORATION] 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67108-3565 MESNEX (MESNA) TABLET, FILM COATED [BAXTER HEALTHCARE COMPANY] 15 Current NDC, Legacy NDC, 2 package rows 20250514_4a51ffdb-f59f-4e02-b3c4-f3457ab7b514.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 67108-3565-9 67108356509 10 BLISTER PACK in 1 CARTON (67108-3565-9) / 1 TABLET, FILM COATED in 1 BLISTER PACK 10 blister pack 2002-03-21 0000-00-00 No No Current