MESNA

Product NDC
10019-953
11-digit product format
100190953
Labeler code
10019
Product ID
10019-953_2e038f62-b464-4ad3-bb54-24e6bb1d7d40
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-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.

Product history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N019884-001MESNEX100MG/MLINJECTABLE / INTRAVENOUSAPRLD, RS1988-12-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N019884-001MESNEX100MG/MLINJECTABLE / INTRAVENOUSAPRLD, RS1988-12-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019884-001MESNEX100MG/MLINJECTABLE / INTRAVENOUSAPRLD, RS1988-12-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08N019884-001MESNEX100MG/MLINJECTABLE / INTRAVENOUSAPRLD, RS1988-12-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019884-001MESNEX100MG/MLINJECTABLE / INTRAVENOUSAPRLD, RS1988-12-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019884-001MESNEX100MG/MLINJECTABLE / INTRAVENOUSAPRLD, RS1988-12-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019884-001MESNEX100MG/MLINJECTABLE / INTRAVENOUSAPRLD, RS1988-12-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019884-001MESNEX100MG/MLINJECTABLE / INTRAVENOUSAPRLD, RS1988-12-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019884-001MESNEX100MG/MLINJECTABLE / INTRAVENOUSAPRLD, RS1988-12-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019884-001MESNEX100MG/MLINJECTABLE / INTRAVENOUSAPRLD, RS1988-12-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N019884-001MESNEX100MG/MLINJECTABLE / INTRAVENOUSAPRLD, RS1988-12-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019884-001MESNEX100MG/MLINJECTABLE / INTRAVENOUSAPRLD, RS1988-12-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019884-001MESNEX100MG/MLINJECTABLE / INTRAVENOUSAPRLD, RS1988-12-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019884-001MESNEX100MG/MLINJECTABLE / INTRAVENOUSAPRLD, RS1988-12-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05N019884-001MESNEX100MG/MLINJECTABLE / INTRAVENOUSAPRLD, RS1988-12-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N019884-001MESNEX100MG/MLINJECTABLE / INTRAVENOUSAPRLD, RS1988-12-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N019884-001MESNEX100MG/MLINJECTABLE / INTRAVENOUSAPRLD, RS1988-12-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N019884-001MESNEX100MG/MLINJECTABLE / INTRAVENOUSAPRLD, RS1988-12-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N019884-001MESNEX100MG/MLINJECTABLE / INTRAVENOUSAPRLD, RS1988-12-3074a2ff9319b5…
2022-03-09 01:35 UTC2022-03N019884-001MESNEX100MG/MLINJECTABLE / INTRAVENOUSAPRLD, RS1988-12-30bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N019884-001MESNEX100MG/MLINJECTABLE / INTRAVENOUSAPRLD, RS1988-12-30782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N019884-001MESNEX100MG/MLINJECTABLE / INTRAVENOUSAPRLD, RS1988-12-3087673890dc5c…
2021-03-12 10:30 UTC2021-03N019884-001MESNEX100MG/MLINJECTABLE / INTRAVENOUSAPRLD, RS1988-12-305aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N019884-001MESNEX100MG/MLINJECTABLE / INTRAVENOUSAPRLD, RS1988-12-308869cabd3fbd…
2020-11-12 02:37 UTC2020-11N019884-001MESNEX100MG/MLINJECTABLE / INTRAVENOUSAPRLD, RS1988-12-30c0c555d07b60…
2019-12-14 00:12 UTC2019-12N019884-001MESNEX100MG/MLINJECTABLE / INTRAVENOUSAPRLD, RS1988-12-303f01610625f2…
2019-09-15 20:21 UTC2019-09N019884-001MESNEX100MG/MLINJECTABLE / INTRAVENOUSAPRLD, RS1988-12-30b00525d2431f…
2019-07-19 19:46 UTC2019-07N019884-001MESNEX100MG/MLINJECTABLE / INTRAVENOUSAPRLD, RS1988-12-30ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N019884-001MESNEX100MG/MLINJECTABLE / INTRAVENOUSAPRLD, RS1988-12-306a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N019884-001MESNEX100MG/MLINJECTABLE / INTRAVENOUSAPRLD, RS1988-12-301c564ffb4f44…
2023-12-20 04:57 UTC2023-12N019884-001MESNEX100MG/MLINJECTABLE / INTRAVENOUSAPRLD, RS1988-12-30ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N019884-001MESNEX100MG/MLINJECTABLE / INTRAVENOUSAPRLD, RS1988-12-30a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N019884-001MESNEX100MG/MLINJECTABLE / INTRAVENOUSAPRLD, RS1988-12-309b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N019884-001MESNEX100MG/MLINJECTABLE / INTRAVENOUSAPRLD, RS1988-12-30a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N019884-001MESNEX100MG/MLINJECTABLE / INTRAVENOUSAPRLD, RS1988-12-303f0d92c62455…
2023-05-13 08:27 UTC2023-05N019884-001MESNEX100MG/MLINJECTABLE / INTRAVENOUSAPRLD, RS1988-12-30053a50430f4f…
2023-01-26 05:58 UTC2023-01N019884-001MESNEX100MG/MLINJECTABLE / INTRAVENOUSAPRLD, RS1988-12-303bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N019884-001MESNEX100MG/MLINJECTABLE / INTRAVENOUSAPRLD, RS1988-12-303a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N019884-001MESNEX100MG/MLINJECTABLE / INTRAVENOUSAPRLD, RS1988-12-30f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N019884-001MESNEX100MG/MLINJECTABLE / INTRAVENOUSAPRLD, RS1988-12-30e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07N019884-001AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N019884-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019884-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08N019884-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019884-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019884-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019884-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019884-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019884-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019884-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N019884-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019884-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019884-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019884-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N019884-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N019884-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N019884-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N019884-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N019884-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N019884-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N019884-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N019884-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03N019884-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N019884-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N019884-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N019884-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09N019884-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07N019884-001AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N019884-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N019884-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N019884-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N019884-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N019884-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N019884-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N019884-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05N019884-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01N019884-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N019884-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N019884-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N019884-001AP1e64feba35796…

Additional Listing Data#

Finished product
Yes
Brand name base
MESNA
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 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
fe1683ef-0569-411e-8188-0499884632adAvailable 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10019-953-01MESNA1 in 1 BOXINJECTION, SOLUTION117
10019-953-02MESNA10 in 1 BOXINJECTION, SOLUTION1017
10019-953-62MESNA10 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION1017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10019-953-01ML - Milliliter10019-953ac1c582f-824a-4991-96c3-0f92c3f1611712013-02-13
10019-953-02ML - Milliliter10019-953db8ea1d6-05f8-4312-94cf-98cb6a25594d12013-02-13
10019-953-62ML - Milliliter10019-95314676856-d153-474c-8170-222dd6044bb612013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MESNAACTIVE INGREDIENTNR7O1405Q9MESNA INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]4
2-MERCAPTOETHANESULFONIC ACIDACTIVE MOIETYVHD28S0H7FMESNA INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]4
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHMESNA INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]4
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KMESNA INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]4
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IMESNA INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10019-953MESNA INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]15Current NDC, Legacy NDC, 3 package rows20250410_fe1683ef-0569-411e-8188-0499884632ad.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.

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
ndc (product): 10019-953
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
204870mesna 100 MG/ML Injectable SolutionPSNfe1683ef-0569-411e-8188-0499884632ad17
204870mesna 100 MG/ML Injectable SolutionSCDfe1683ef-0569-411e-8188-0499884632ad17
204870mesna 1 GM per 10 ML Injectable SolutionSYfe1683ef-0569-411e-8188-0499884632ad17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10019-953-01100190953011 VIAL, MULTI-DOSE in 1 BOX (10019-953-01) / 10 mL in 1 VIAL, MULTI-DOSE (10019-953-62) 1988-12-300000-00-00NoNoCurrent
10019-953-021001909530210 VIAL, MULTI-DOSE in 1 BOX (10019-953-02) / 10 mL in 1 VIAL, MULTI-DOSE (10019-953-62) 1988-12-300000-00-00NoNoCurrent
10019-953-621001909536210 mL in 1 VIAL, MULTI-DOSE10 mlHistorical