MESNA

Product NDC
50742-354
11-digit product format
507420354
Labeler code
50742
Product ID
50742-354_ea85fa84-18f7-4b89-b701-1d9dc01a8e0d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MESNA
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Ingenus Pharmaceuticals, LLC
Application
ANDA218871
Marketing category
ANDA
Marketing start
2025-01-14
Substance
MESNA
Active strength
400 mg/1
Pharmacologic classes
Cytoprotective Agent [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A218871-001MESNAMESNA400MGTABLET / ORALAB2025-01-13

Therapeutic equivalence codes#

Application-product, TE code table
Application-productTE code
A218871-001AB

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MESNAMESNAIngenus Pharmaceuticals, LLC90d64539-33ad-47e8-9de7-17d6c5baaba42025-01-16Warnings, Adverse reactionsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings and cautions

5 WARNINGS AND PRECAUTIONS Hypersensitivity reactions: Anaphylactic reactions have been reported. Less severe hypersensitivity reactions may also occur. Monitor patients. If a reaction occurs, discontinue mesna and provide supportive care. ( 5.1 ) Dermatologic toxicity: Skin rash with eosinophilia and systemic symptoms, Stevens-Johnson syndrome, and toxic epidermal necrolysis have occurred. Skin rash, urticaria, and angioedema have also been seen. Monitor patients. If a reaction occurs, discontinue mesna and provide supportive care. ( 5.2 ) Benzyl alcohol toxicity: Serious and fatal adverse reactions can occur in premature neonates and low-birth weight infants treated with benzyl alcohol-preserved drugs, including MESNEX injection. Avoid use in premature neonates and low-birth weight infants. ( 5.3 ) Laboratory test alterations: False positive tests for urinary ketones and interference with enzymatic CPK activity tests have been seen. ( 5.4 ) 5.1 Hypersensitivity Reactions Mesna may cause systemic hypersensitivity reactions, including anaphylaxis. These reactions may include fever, cardiovascular symptoms (hypotension, tachycardia), acute renal impairment, hypoxia, respiratory distress, urticaria, angioedema, laboratory signs of disseminated intravascular coagulation, hematological abnormalities, increased liver enzymes, nausea, vomiting, arthralgia, and myalgia. These reactions may occur with the first exposure or after several months of exposure. Monitor for signs or symptoms. Discontinue mesna and provide supportive care. 5.2 Dermatologic Toxicity Drug rash with eosinophilia and systemic symptoms and bullous and ulcerative skin and mucosal reactions, consistent with Stevens-Johnson syndrome or toxic epidermal necrolysis have occurred. Mesna may cause skin and mucosal reactions characterized by urticaria, rash, erythema, pruritus, burning sensation, angioedema, periorbital edema, flushing and stomatitis. These reactions may occur with the first exposure or after several months of exposure. Discontinue mesna and provide supportive care. 5.3 Benzyl Alcohol Toxicity Serious adverse reactions including fatal reactions and the “gasping syndrome” occurred in premature neonates and low-birth weight infants who received benzyl alcohol dosages of 99 to 234 mg/kg/day (blood levels of benzyl alcohol were 0.61 to 1.378 mmol/L). Symptoms associated with “gasping syn...

Adverse reactions cross-check#

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adverse reactions

6 ADVERSE REACTIONS The following are discussed in more detail in other sections of the labeling. • Hypersensitivity Reactions [see Warnings and Precautions (5.1) ] • Dermatological Toxicity [see Warnings and Precautions (5.2) ] • Benzyl Alcohol Toxicity [see Warnings and Precautions (5.3) ] • Laboratory Test Interferences [see Warnings and Precautions (5.4) ] • Use in Patients with a History of Adverse Reactions to Thiol Compounds [see Warnings and Precautions (5.5) ] The most common adverse reactions (> 10%) when mesna is given with ifosfamide are nausea, vomiting, constipation, leukopenia, fatigue, fever, anorexia, thrombocytopenia, anemia, granulocytopenia, diarrhea, asthenia, abdominal pain, headache, alopecia, and somnolence. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Ingenus Pharmaceuticals, LLC at 1-877-748-1970 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Mesna adverse reaction data are available from four Phase 1 studies in which single oral doses of 600-2400 mg of mesna tablets were administered to a total of 82 healthy volunteers. In two Phase 1 multiple-dose studies where healthy volunteers received mesna tablets alone or intravenous MESNEX followed by repeated doses of mesna tablets, flatulence and rhinitis were reported. Additional adverse reactions in healthy volunteers receiving mesna alone included abdominal pain/colic, epigastric pain/burning, mucosal irritation, lightheadedness, back pain, arthralgia, myalgia, conjunctivitis, nasal congestion, rigors, paresthesia, photophobia, fatigue, lymphadenopathy, extremity pain, malaise, chest pain, dysuria, pleuritic pain, dry mouth, dyspnea, and hyperhidrosis. In healthy volunteers, mesna was commonly associated with a rapid (within 24 hours) decrease in lymphocyte count, which was generally reversible within one week of administration. Because mesna is used in combination with ifosfamide or ifosfamide-containing chemotherapy regimens, it is difficult to distinguish the adverse reactions which may be due to mesna from those caused by the concomitantly administered cytotoxic agents. Advers...

adverse reactions table

Table 3: Adverse Reactions in ≥5% of Patients Receiving Mesna in combination with Ifosfamide-containing Regimens Mesna RegimenIntravenous-Oral-OralIntravenous dosing of ifosfamide and MESNEX followed by oral doses of mesna according to the applicable dosage schedule [see Dosage and Administration (2)].N exposed119 (100%)Incidence of AEs106 (89.1%)Nausea64 (53.8)Vomiting45 (37.8)Constipation21 (17.6)Leukopenia21 (17.6)Fatigue24 (20.2)Fever18 (15.1)Anorexia19 (16.0)Thrombocytopenia16 (13.4)Anemia21 (17.6)Granulocytopenia15 (12.6)Asthenia21 (17.6)Abdominal Pain18 (15.1)Alopecia13 (10.9)Dyspnea11 (9.2)Chest Pain11 (9.2)Hypokalemia11 (9.2)Diarrhea17 (14.3)Dizziness5 (4.2)Headache13 (10.9)Pain10 (8.4)Sweating Increased2 (1.7)Back Pain6 (5.0)Hematuria7 (5.9)Injection Site Reaction10 (8.4)Edema9 (7.6)Edema Peripheral8 (6.7)Somnolence12 (10.1)Anxiety4 (3.4)Confusion6 (5.0)Face Edema5 (4.2)Insomnia11 (9.2)Coughing10 (8.4)Dyspepsia6 (5.0)Hypotension6 (5.0)Pallor6 (5.0)Dehydration7 (5.9)Pneumonia8 (6.7)Tachycardia7 (5.9)Flushing6 (5.0)

Additional Listing Data#

Finished product
Yes
Brand name base
MESNA
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MESNA400 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiNR7O1405Q9
Rxcui142113

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
50742-354-01MESNA10 in 1 BLISTER PACKTABLET, FILM COATED102
50742-354-01MESNA1 in 1 CARTONTABLET, FILM COATED12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50742-354-01EA - Each50742-3544884bdf1-74cd-4322-86ef-ce7f86454eb512025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50742-354MESNA TABLET, FILM COATED [INGENUS PHARMACEUTICALS, LLC]2Current NDC, 2 package rows20250117_90d64539-33ad-47e8-9de7-17d6c5baaba4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
142113mesna 400 MG Oral TabletPSN90d64539-33ad-47e8-9de7-17d6c5baaba42
142113mesna 400 MG Oral TabletSCD90d64539-33ad-47e8-9de7-17d6c5baaba42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50742-354-01507420354011 BLISTER PACK in 1 CARTON (50742-354-01) / 10 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2025-01-14NoNoCurrent