FDA.reportPublic FDA data

MESNEX

Product NDC
0338-1307
11-digit product format
003381307
Labeler code
0338
Product ID
0338-1307_1553b83c-11d2-41e7-a140-a373a8fc6483
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MESNA
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Baxter Healthcare Company
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 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N019884-001MESNEXMESNA100MG/MLINJECTABLE / INTRAVENOUSAPRLD, RS1988-12-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
N019884-001AP

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N019884-001MESNEX100MG/MLINJECTABLE / INTRAVENOUSAPRLD, RS1988-12-30a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06N019884-001AP1a50c72e98297…

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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MESNEXMESNABamboo US Bidco LCC1dd69e84-616d-fb77-e063-6394a90af2f42025-12-10Warnings, Adverse reactionsExact identifier
application applno (NDA): 019884
application number: NDA019884
MESNEXMESNABaxter Healthcare Company49fdfbc3-69f8-4706-9d11-bf60e4e7811b2018-12-17Warnings, Adverse reactionsExact identifier
application applno (NDA): 019884
application number: NDA019884
MESNAMESNABaxter Healthcare Companyfe1683ef-0569-411e-8188-0499884632ad2018-12-17Warnings, Adverse reactionsExact identifier
application applno (NDA): 019884
application number: NDA019884
MESNAMESNABaxter Healthcare Companya880160b-fa82-453a-a971-29ab897876a72018-12-17Warnings, Adverse reactionsExact identifier
application applno (NDA): 019884
application number: NDA019884
MESNEXMESNABaxter Healthcare Company2e8eebc3-ea75-4c57-bfe1-2c5dc2c378062018-07-24Warnings, Adverse reactionsExact identifier
application applno (NDA): 019884
application number: NDA019884
ndc (product): 0338-1307

Additional Listing Data#

Finished product
Yes
Brand name base
MESNEX
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MESNA100 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
NR7O1405Q9Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
204870Internal RxNorm lookup
899350Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2e8eebc3-ea75-4c57-bfe1-2c5dc2c37806Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d255b108-5509-4278-c140-9ab9db8148b2Product name220251105
d4a974a1-ae49-8695-229c-b23b6bff9d4bProduct name320180221
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0338-1307-052020-02-05C16284748780-19d75b9d1-12db-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use MESNEX safely and effectively. See full prescribing information for MESNEX. MESNEX (mesna) injection, for intravenous use MESNEX (mesna) tablets, for oral use Initial U.S. Approval: 1988
0338-1307-052020-02-05C16284748780-19d75b9d1-12db-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use MESNEX safely and effectively. See full prescribing information for MESNEX. MESNEX (mesna) injection, for intravenous use MESNEX (mesna) tablets, for oral use Initial U.S. Approval: 1988
0338-1307-052020-02-05C16284748780-19d75b9d1-12db-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use MESNEX safely and effectively. See full prescribing information for MESNEX. MESNEX (mesna) injection, for intravenous use MESNEX (mesna) tablets, for oral use Initial U.S. Approval: 1988
0338-1307-052020-01-31C16284748780-19d75b9d1-12db-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use MESNEX safely and effectively. See full prescribing information for MESNEX. MESNEX (mesna) injection, for intravenous use MESNEX (mesna) tablets, for oral use Initial U.S. Approval: 1988
0338-1307-052020-01-31C16284748780-19d75b9d1-12db-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use MESNEX safely and effectively. See full prescribing information for MESNEX. MESNEX (mesna) injection, for intravenous use MESNEX (mesna) tablets, for oral use Initial U.S. Approval: 1988
0338-1307-052020-01-31C16284748780-19d75b9d1-12db-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use MESNEX safely and effectively. See full prescribing information for MESNEX. MESNEX (mesna) injection, for intravenous use MESNEX (mesna) tablets, for oral use Initial U.S. Approval: 1988

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0338-1307-05MESNEX1 in 1 BOXINJECTION, SOLUTION110
0338-1307-10MESNEX10 mL in 1 VIALINJECTION, SOLUTION1010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0338-1307MESNEX (MESNA) INJECTION, SOLUTION [BAXTER HEALTHCARE COMPANY]8Current NDC, Legacy NDC, 2 package rows20250410_2e8eebc3-ea75-4c57-bfe1-2c5dc2c37806.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
204870mesna 100 MG/ML Injectable SolutionPSN2e8eebc3-ea75-4c57-bfe1-2c5dc2c3780610
899350Mesnex 100 MG/ML Injectable SolutionPSN2e8eebc3-ea75-4c57-bfe1-2c5dc2c3780610
899350mesna 100 MG/ML Injectable Solution [Mesnex]SBD2e8eebc3-ea75-4c57-bfe1-2c5dc2c3780610
204870mesna 100 MG/ML Injectable SolutionSCD2e8eebc3-ea75-4c57-bfe1-2c5dc2c3780610
204870mesna 1 GM per 10 ML Injectable SolutionSY2e8eebc3-ea75-4c57-bfe1-2c5dc2c3780610
899350Mesnex 100 MG/ML Concentrate for Injectable SolutionSY2e8eebc3-ea75-4c57-bfe1-2c5dc2c3780610
899350Mesnex 100 MG/ML Injectable SolutionSY2e8eebc3-ea75-4c57-bfe1-2c5dc2c3780610

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0338-1307-05003381307051 VIAL in 1 BOX (0338-1307-05) / 10 mL in 1 VIAL (0338-1307-10) 1 vial2018-07-180000-00-00NoNoCurrent
0338-1307-100033813071010 mL in 1 VIAL10 mlHistorical