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 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 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.
Product history page 1 of 2 · 42 observed 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 N020855-001 MESNEX 400MG TABLET / ORAL AB RLD, RS 2002-03-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020855-001 MESNEX 400MG TABLET / ORAL AB RLD, RS 2002-03-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020855-001 MESNEX 400MG TABLET / ORAL AB RLD, RS 2002-03-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020855-001 MESNEX 400MG TABLET / ORAL AB RLD, RS 2002-03-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020855-001 MESNEX 400MG TABLET / ORAL AB RLD, RS 2002-03-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020855-001 MESNEX 400MG TABLET / ORAL AB RLD, RS 2002-03-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020855-001 MESNEX 400MG TABLET / ORAL RLD, RS 2002-03-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020855-001 MESNEX 400MG TABLET / ORAL RLD, RS 2002-03-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020855-001 MESNEX 400MG TABLET / ORAL RLD, RS 2002-03-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020855-001 MESNEX 400MG TABLET / ORAL RLD, RS 2002-03-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020855-001 MESNEX 400MG TABLET / ORAL RLD, RS 2002-03-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020855-001 MESNEX 400MG TABLET / ORAL RLD, RS 2002-03-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020855-001 MESNEX 400MG TABLET / ORAL RLD, RS 2002-03-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020855-001 MESNEX 400MG TABLET / ORAL RLD, RS 2002-03-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020855-001 MESNEX 400MG TABLET / ORAL RLD, RS 2002-03-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020855-001 MESNEX 400MG TABLET / ORAL RLD, RS 2002-03-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020855-001 MESNEX 400MG TABLET / ORAL RLD, RS 2002-03-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020855-001 MESNEX 400MG TABLET / ORAL RLD, RS 2002-03-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020855-001 MESNEX 400MG TABLET / ORAL RLD, RS 2002-03-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020855-001 MESNEX 400MG TABLET / ORAL RLD, RS 2002-03-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020855-001 MESNEX 400MG TABLET / ORAL RLD, RS 2002-03-21 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020855-001 MESNEX 400MG TABLET / ORAL RLD, RS 2002-03-21 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020855-001 MESNEX 400MG TABLET / ORAL RLD, RS 2002-03-21 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020855-001 MESNEX 400MG TABLET / ORAL RLD, RS 2002-03-21 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020855-001 MESNEX 400MG TABLET / ORAL RLD, RS 2002-03-21 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020855-001 MESNEX 400MG TABLET / ORAL RLD, RS 2002-03-21 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020855-001 MESNEX 400MG TABLET / ORAL RLD, RS 2002-03-21 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020855-001 MESNEX 400MG TABLET / ORAL RLD, RS 2002-03-21 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020855-001 MESNEX 400MG TABLET / ORAL RLD, RS 2002-03-21 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N020855-001 MESNEX 400MG TABLET / ORAL RLD, RS 2002-03-21 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N020855-001 MESNEX 400MG TABLET / ORAL RLD, RS 2002-03-21 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020855-001 MESNEX 400MG TABLET / ORAL RLD, RS 2002-03-21 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020855-001 MESNEX 400MG TABLET / ORAL RLD, RS 2002-03-21 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020855-001 MESNEX 400MG TABLET / ORAL RLD, RS 2002-03-21 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020855-001 MESNEX 400MG TABLET / ORAL RLD, RS 2002-03-21 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N020855-001 MESNEX 400MG TABLET / ORAL RLD, RS 2002-03-21 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N020855-001 MESNEX 400MG TABLET / ORAL RLD, RS 2002-03-21 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020855-001 MESNEX 400MG TABLET / ORAL RLD, RS 2002-03-21 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N020855-001 MESNEX 400MG TABLET / ORAL RLD, RS 2002-03-21 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020855-001 MESNEX 400MG TABLET / ORAL RLD, RS 2002-03-21 e64feba35796…
Observed Orange Book normalized TE history# 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
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 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