NDC 68083-161

Mesna

Mesna Injection

Mesna is a Intravenous Solution in the Human Prescription Drug category. It is labeled and distributed by Gland Pharma Limited. The primary component is Mesna.

Product ID68083-161_19e221d8-3b29-452f-8781-2ba1e55482d0
NDC68083-161
Product TypeHuman Prescription Drug
Proprietary NameMesna
Generic NameMesna Injection
Dosage FormSolution
Route of AdministrationINTRAVENOUS
Marketing Start Date2017-12-20
Marketing CategoryANDA / ANDA
Application NumberANDA206992
Labeler NameGland Pharma Limited
Substance NameMESNA
Active Ingredient Strength100 mg/mL
Pharm ClassesCytoprotective Agent [EPC]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 68083-161-01

1 VIAL, MULTI-DOSE in 1 CARTON (68083-161-01) > 10 mL in 1 VIAL, MULTI-DOSE
Marketing Start Date2017-12-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68083-161-10 [68083016110]

Mesna SOLUTION
Marketing CategoryANDA
Application NumberANDA206992
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-12-20

NDC 68083-161-01 [68083016101]

Mesna SOLUTION
Marketing CategoryANDA
Application NumberANDA206992
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-12-20

Drug Details

Active Ingredients

IngredientStrength
MESNA100 mg/mL

OpenFDA Data

SPL SET ID:a7af968c-05cf-4438-94ba-96a2baf9c367
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 204870
  • UPC Code
  • 0368083161019
  • Pharmacological Class

    • Cytoprotective Agent [EPC]

    NDC Crossover Matching brand name "Mesna" or generic name "Mesna Injection"

    NDCBrand NameGeneric Name
    0703-4805MesnaMesna
    10019-951MESNAMESNA
    10019-953MESNAMESNA
    25021-201Mesnamesna
    47781-622MesnaMesna
    63323-733MesnaMESNA
    68083-161MesnaMesna Injection
    70860-209Mesnamesna
    0338-1305MESNEXmesna
    0338-1307MESNEXMESNA
    67108-3565MESNEXMESNA

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