NDC 0338-0126

MYXREDLIN

Insulin Human

MYXREDLIN is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Baxter Healthcare Corporation. The primary component is Insulin Human.

Product ID0338-0126_2094d305-e942-4c30-ade2-25f25677ed8b
NDC0338-0126
Product TypeHuman Prescription Drug
Proprietary NameMYXREDLIN
Generic NameInsulin Human
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2019-07-12
Marketing CategoryBLA / NDA
Application NumberBLA208157
Labeler NameBaxter Healthcare Corporation
Substance NameINSULIN HUMAN
Active Ingredient Strength1 [iU]/mL
Pharm ClassesInsulin [CS], Insulin [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0338-0126-12

12 CONTAINER in 1 CARTON (0338-0126-12) > 100 mL in 1 CONTAINER
Marketing Start Date2019-07-12
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0338-0126-12 [00338012612]

MYXREDLIN INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA208157
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-07-12

Drug Details

Active Ingredients

IngredientStrength
INSULIN HUMAN1 [iU]/mL

OpenFDA Data

SPL SET ID:afca6e80-a802-49fb-a978-5fe28a173001
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 2179749
  • 2179744
  • Pharmacological Class

    • Insulin [EPC]
    • Insulin [CS]

    NDC Crossover Matching brand name "MYXREDLIN" or generic name "Insulin Human"

    NDCBrand NameGeneric Name
    0338-0126MYXREDLINinsulin human
    47918-874AfrezzaInsulin Human
    0002-8215HumulinInsulin human
    0002-8315HumulinInsulin human
    0002-8501HumulinInsulin human
    0002-8715HumulinInsulin human
    0002-8803HumulinInsulin human
    0002-8805HumulinInsulin human
    0002-8824HumulinInsulin human

    Trademark Results [MYXREDLIN]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    MYXREDLIN
    MYXREDLIN
    87287569 5903597 Live/Registered
    Baxter International Inc.
    2017-01-03

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