FDA.reportPublic FDA data

NDC 0338-1307-10 - MESNEX

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
0338-1307
Requested NDC
0338-1307-10
Package NDCs from labels
0338-1307-10, 0338-1307-05
Manufacturer
Baxter Healthcare Company | Baxter Deutschland GmbH
Effective date
2018-07-24
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
MESNEX - Baxter Healthcare Company | Baxter Deutschland GmbHBaxter Healthcare Company | Baxter Deutschland GmbH2018-07-24HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2020-02-05These 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
2020-02-05These 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
2020-02-05These 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
2020-01-31These 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
2020-01-31These 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
2020-01-31These 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

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 2 of 3 · 43 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Meijer Pain Lidocaine Plus Relieving AnalgesicBENZYL ALCOHOL AND LIDOCAINE HYDROCHLORIDEMeijer Distribution, Incb7385140-3f63-4cbc-b557-de1d29d1ea362024-11-15WarningsExact identifier
unii: LKG8494WBH
ChemtoxTRITICUM AESTIVUM, BERBERIS VULGARIS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, RHAMNUS FRANGULA, RHAMNUS PURSHIANA, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, LYMPH NODE (SUIS), THYROIDINUM (SUIS), BELLADONNA, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, SALICYLICUM ACIDUM, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM, POTASSIUM SORBATE,BioActive Nutritional, Inc.9aa060f1-f8f6-46e6-a7d0-bd46a73f26762024-10-17WarningsExact identifier
unii: LKG8494WBH
MesnaMESNAFresenius Kabi USA, LLCef161ede-0451-43c8-b0e5-cb108b138e382024-10-15Warnings, Adverse reactionsExact identifier
rxcui: 204870
unii: NR7O1405Q9
Fast Freeze Lidocaine Roll-OnLIDOCAINE HYDROCHLORIDE, BENZYL ALCOHOLNatural Essentials, Inc.74b06366-5eb4-4eba-aa2b-2b672828294d2024-10-04WarningsExact identifier
unii: LKG8494WBH
CVS Health Lidocaine Plus Pain RelievingLIDOCAINE HYDROCHLORIDE, BENZYL ALCOHOLNATURAL ESSENTIALS, INC.1adb9b74-4a01-4461-b845-f3aedcb3f8102024-10-01WarningsExact identifier
unii: LKG8494WBH
IvarestZINC OXIDE, BENZYL ALCOHOL, AND DIPHENHYDRAMINE HYDROCHLORIDEBlistex Inc6f68cbbb-6269-4bb3-8cc9-50b146703b422024-07-09WarningsExact identifier
unii: LKG8494WBH
Walgreens Lidocaine Plus CreamBENZYL ALCOHOL AND LIDOCAINE HYDROCHLORIDEWalgreens Companye33e0097-31d6-8083-e053-2a95a90af5d22024-05-09WarningsExact identifier
unii: LKG8494WBH
HealthWise Lidocaine Plus CreamBENZYL ALCOHOL, LIDOCAINE HYDROCHLORIDEVeridian Healthcare16f26249-b508-2c6e-e063-6394a90a265b2024-04-25WarningsExact identifier
unii: LKG8494WBH
CVS Maximum Strength LIDOCAINE PLUSBENZYL ALCOHOL, LIDOCAINE HYDROCHLORIDECVS Pharmacy Inc.e6aff579-affb-41bb-8e36-53ea484cb0c52023-11-26WarningsExact identifier
unii: LKG8494WBH
LipotoxSQUALENE, CHOLESTERINUM, ESTRADIOL, PROGESTERONE, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM, ARSENICUM ALBUM, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM, PETROLEUM JELLY, PHENYL BUTAZONE, PLUMBUM METALLICUM,BioActive Nutritional, Inc.a1538692-ca00-4e52-9b7e-409767ee27e12023-09-05WarningsExact identifier
unii: LKG8494WBH
Anubis BarcelonaDMAE, ZIRHAFIRMANUBIS COSMETICS SLf2274f8c-08aa-eb02-e053-2a95a90a39982023-09-01WarningsExact identifier
unii: LKG8494WBH
Anubis BarcelonaPROPANEDIOL, GLYCERIN, MAGNESIUM ASCORBYL PHOSPHATEANUBIS COSMETICS SLeb53cba1-0509-43bc-e053-2995a90a5e092023-09-01WarningsExact identifier
unii: LKG8494WBH
mesnaMESNAHikma Pharmaceuticals USA Inc.8012b97b-4e39-451f-8e04-542d196e8bc62023-05-03Warnings, Adverse reactionsExact identifier
rxcui: 204870
unii: NR7O1405Q9
MesnaMESNA INJECTIONGland Pharma Limiteda7af968c-05cf-4438-94ba-96a2baf9c3672022-10-07Warnings, Adverse reactionsExact identifier
rxcui: 204870
unii: NR7O1405Q9
Miracle FootCream LavenderUREA, GLYCERIN, ALOE, DISODIUM EDTAAloe Vera Korea Co.,Ltd.db520c80-2a2a-5eb1-e053-2995a90a5bb42022-03-28WarningsExact identifier
unii: 7FLD91C86K
Miracle FootCream LemonUREA, GLYCERIN, ALOE, DISODIUM EDTAAloe Vera Korea Co.,Ltd.db525c63-29fd-2033-e053-2995a90a56b92022-03-28WarningsExact identifier
unii: 7FLD91C86K
MESNEXMESNABaxter Healthcare Company4a51ffdb-f59f-4e02-b3c4-f3457ab7b5142019-12-21Warnings, Adverse reactionsExact identifier
unii: NR7O1405Q9
MESNEXMESNABaxter Healthcare Company49fdfbc3-69f8-4706-9d11-bf60e4e7811b2018-12-17Warnings, Adverse reactionsExact identifier
application number: NDA019884
rxcui: 899350
rxcui: 204870
unii: NR7O1405Q9
MESNAMESNABaxter Healthcare Companyfe1683ef-0569-411e-8188-0499884632ad2018-12-17Warnings, Adverse reactionsExact identifier
application number: NDA019884
rxcui: 204870
unii: NR7O1405Q9
MESNAMESNABaxter Healthcare Companya880160b-fa82-453a-a971-29ab897876a72018-12-17Warnings, Adverse reactionsExact identifier
application number: NDA019884
rxcui: 204870
unii: NR7O1405Q9

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.