Home NDC 0338-1305 MESNEX
Product NDC 0338-1305
11-digit product format 003381305
Labeler code 0338
Product ID 0338-1305_74c4c92d-675a-47c0-a42d-2d1f6721e4e8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name mesna
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Baxter Healthcare Corporation
Application NDA019884
Marketing category NDA
Marketing start 1988-12-30
Substance MESNA
Active strength 100 mg/mL
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 N019884-001 MESNEX MESNA 100MG/ML INJECTABLE / INTRAVENOUS AP RLD, RS 1988-12-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N019884-001 AP
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 N019884-001 MESNEX 100MG/ML INJECTABLE / INTRAVENOUS AP RLD, RS 1988-12-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N019884-001 MESNEX 100MG/ML INJECTABLE / INTRAVENOUS AP RLD, RS 1988-12-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019884-001 MESNEX 100MG/ML INJECTABLE / INTRAVENOUS AP RLD, RS 1988-12-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N019884-001 MESNEX 100MG/ML INJECTABLE / INTRAVENOUS AP RLD, RS 1988-12-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019884-001 MESNEX 100MG/ML INJECTABLE / INTRAVENOUS AP RLD, RS 1988-12-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019884-001 MESNEX 100MG/ML INJECTABLE / INTRAVENOUS AP RLD, RS 1988-12-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019884-001 MESNEX 100MG/ML INJECTABLE / INTRAVENOUS AP RLD, RS 1988-12-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019884-001 MESNEX 100MG/ML INJECTABLE / INTRAVENOUS AP RLD, RS 1988-12-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019884-001 MESNEX 100MG/ML INJECTABLE / INTRAVENOUS AP RLD, RS 1988-12-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019884-001 MESNEX 100MG/ML INJECTABLE / INTRAVENOUS AP RLD, RS 1988-12-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N019884-001 MESNEX 100MG/ML INJECTABLE / INTRAVENOUS AP RLD, RS 1988-12-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019884-001 MESNEX 100MG/ML INJECTABLE / INTRAVENOUS AP RLD, RS 1988-12-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019884-001 MESNEX 100MG/ML INJECTABLE / INTRAVENOUS AP RLD, RS 1988-12-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N019884-001 MESNEX 100MG/ML INJECTABLE / INTRAVENOUS AP RLD, RS 1988-12-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N019884-001 MESNEX 100MG/ML INJECTABLE / INTRAVENOUS AP RLD, RS 1988-12-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N019884-001 MESNEX 100MG/ML INJECTABLE / INTRAVENOUS AP RLD, RS 1988-12-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N019884-001 MESNEX 100MG/ML INJECTABLE / INTRAVENOUS AP RLD, RS 1988-12-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N019884-001 MESNEX 100MG/ML INJECTABLE / INTRAVENOUS AP RLD, RS 1988-12-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N019884-001 MESNEX 100MG/ML INJECTABLE / INTRAVENOUS AP RLD, RS 1988-12-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N019884-001 MESNEX 100MG/ML INJECTABLE / INTRAVENOUS AP RLD, RS 1988-12-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N019884-001 MESNEX 100MG/ML INJECTABLE / INTRAVENOUS AP RLD, RS 1988-12-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N019884-001 MESNEX 100MG/ML INJECTABLE / INTRAVENOUS AP RLD, RS 1988-12-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N019884-001 MESNEX 100MG/ML INJECTABLE / INTRAVENOUS AP RLD, RS 1988-12-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N019884-001 MESNEX 100MG/ML INJECTABLE / INTRAVENOUS AP RLD, RS 1988-12-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N019884-001 MESNEX 100MG/ML INJECTABLE / INTRAVENOUS AP RLD, RS 1988-12-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N019884-001 MESNEX 100MG/ML INJECTABLE / INTRAVENOUS AP RLD, RS 1988-12-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N019884-001 MESNEX 100MG/ML INJECTABLE / INTRAVENOUS AP RLD, RS 1988-12-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N019884-001 MESNEX 100MG/ML INJECTABLE / INTRAVENOUS AP RLD, RS 1988-12-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N019884-001 MESNEX 100MG/ML INJECTABLE / INTRAVENOUS AP RLD, RS 1988-12-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N019884-001 MESNEX 100MG/ML INJECTABLE / INTRAVENOUS AP RLD, RS 1988-12-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N019884-001 MESNEX 100MG/ML INJECTABLE / INTRAVENOUS AP RLD, RS 1988-12-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N019884-001 MESNEX 100MG/ML INJECTABLE / INTRAVENOUS AP RLD, RS 1988-12-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N019884-001 MESNEX 100MG/ML INJECTABLE / INTRAVENOUS AP RLD, RS 1988-12-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N019884-001 MESNEX 100MG/ML INJECTABLE / INTRAVENOUS AP RLD, RS 1988-12-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N019884-001 MESNEX 100MG/ML INJECTABLE / INTRAVENOUS AP RLD, RS 1988-12-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N019884-001 MESNEX 100MG/ML INJECTABLE / INTRAVENOUS AP RLD, RS 1988-12-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N019884-001 MESNEX 100MG/ML INJECTABLE / INTRAVENOUS AP RLD, RS 1988-12-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N019884-001 MESNEX 100MG/ML INJECTABLE / INTRAVENOUS AP RLD, RS 1988-12-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N019884-001 MESNEX 100MG/ML INJECTABLE / INTRAVENOUS AP RLD, RS 1988-12-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N019884-001 MESNEX 100MG/ML INJECTABLE / INTRAVENOUS AP RLD, RS 1988-12-30 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base MESNEX
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MESNA 100 mg/mL
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 204870 Internal RxNorm lookup 899350 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 0338-1305-01 MESNEX 10 mL in 1 VIAL, MULTI-DOSE INJECTION, SOLUTION 10 20 0338-1305-01 MESNEX 1 in 1 BOX INJECTION, SOLUTION 1 20 0338-1305-03 MESNEX 10 mL in 1 VIAL, MULTI-DOSE INJECTION, SOLUTION 10 20 0338-1305-03 MESNEX 10 in 1 BOX INJECTION, SOLUTION 10 20
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0338-1305 MESNEX (MESNA) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION] 18 Current NDC, Legacy NDC, 4 package rows 20250410_49fdfbc3-69f8-4706-9d11-bf60e4e7811b.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 · 5 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0338-1305-01 00338130501 1 VIAL, MULTI-DOSE in 1 BOX (0338-1305-01) / 10 mL in 1 VIAL, MULTI-DOSE 1988-12-30 0000-00-00 No No Current 0338-1305-03 00338130503 10 VIAL, MULTI-DOSE in 1 BOX (0338-1305-03) / 10 mL in 1 VIAL, MULTI-DOSE 1988-12-30 0000-00-00 No No Current