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 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
ndc (product): 0338-1305
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

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
49fdfbc3-69f8-4706-9d11-bf60e4e7811bAvailable 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0338-1305-01MESNEX10 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION1020
0338-1305-01MESNEX1 in 1 BOXINJECTION, SOLUTION120
0338-1305-03MESNEX10 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION1020
0338-1305-03MESNEX10 in 1 BOXINJECTION, SOLUTION1020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0338-1305-01ML - Milliliter0338-1305fadeb022-7613-45b9-b1a5-734f9001cc0212012-07-24
0338-1305-03ML - Milliliter0338-13051b66bb8f-6cbc-470a-8cce-bef5bb92103912012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0338-1305MESNEX (MESNA) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]18Current NDC, Legacy NDC, 4 package rows20250410_49fdfbc3-69f8-4706-9d11-bf60e4e7811b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
204870mesna 100 MG/ML Injectable SolutionPSN49fdfbc3-69f8-4706-9d11-bf60e4e7811b20
899350Mesnex 100 MG/ML Injectable SolutionPSN49fdfbc3-69f8-4706-9d11-bf60e4e7811b20
899350mesna 100 MG/ML Injectable Solution [Mesnex]SBD49fdfbc3-69f8-4706-9d11-bf60e4e7811b20
204870mesna 100 MG/ML Injectable SolutionSCD49fdfbc3-69f8-4706-9d11-bf60e4e7811b20
204870mesna 1 GM per 10 ML Injectable SolutionSY49fdfbc3-69f8-4706-9d11-bf60e4e7811b20
899350Mesnex 100 MG/ML Concentrate for Injectable SolutionSY49fdfbc3-69f8-4706-9d11-bf60e4e7811b20
899350Mesnex 100 MG/ML Injectable SolutionSY49fdfbc3-69f8-4706-9d11-bf60e4e7811b20

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0338-1305-01003381305011 VIAL, MULTI-DOSE in 1 BOX (0338-1305-01) / 10 mL in 1 VIAL, MULTI-DOSE1988-12-300000-00-00NoNoCurrent
0338-1305-030033813050310 VIAL, MULTI-DOSE in 1 BOX (0338-1305-03) / 10 mL in 1 VIAL, MULTI-DOSE1988-12-300000-00-00NoNoCurrent