NDC 0002-8214

BASAGLAR Tempo Pen

Insulin Glargine

BASAGLAR Tempo Pen is a Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Eli Lilly And Company. The primary component is Insulin Glargine.

Product ID0002-8214_5b9ea83f-fed3-4986-882f-67e4d214a2a2
NDC0002-8214
Product TypeHuman Prescription Drug
Proprietary NameBASAGLAR Tempo Pen
Generic NameInsulin Glargine
Dosage FormInjection, Solution
Route of AdministrationSUBCUTANEOUS
Marketing Start Date2015-12-16
Marketing CategoryBLA / BLA
Application NumberBLA205692
Labeler NameEli Lilly and Company
Substance NameINSULIN GLARGINE
Active Ingredient Strength100 [iU]/mL
Pharm ClassesInsulin [Chemical/Ingredient],Insulin Analog [EPC]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 0002-8214-05

5 SYRINGE in 1 CARTON (0002-8214-05) > 3 mL in 1 SYRINGE (0002-8214-01)
Marketing Start Date2019-11-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0002-8214-05 [00002821405]

BASAGLAR Tempo Pen INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA205692
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-11-15

NDC 0002-8214-01 [00002821401]

BASAGLAR Tempo Pen INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA205692
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-12-16

Drug Details

Active Ingredients

IngredientStrength
INSULIN GLARGINE100 [iU]/mL

OpenFDA Data

SPL SET ID:0ad21db3-2b1c-4ed9-a687-bdd6a74d0aae
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 847230
  • 2268064
  • 2268065
  • 1736863
  • PHarm Class EPC
  • Insulin Analog [EPC]
  • NUI Code
  • N0000175453
  • N0000004931
  • Pharmacological Class

    • Insulin [Chemical/Ingredient]
    • Insulin Analog [EPC]

    NDC Crossover Matching brand name "BASAGLAR Tempo Pen" or generic name "Insulin Glargine"

    NDCBrand NameGeneric Name
    0002-7715BASAGLARInsulin glargine
    0002-8214BASAGLARInsulin glargine
    0088-2220Lantusinsulin glargine
    0088-2219Lantus Solostarinsulin glargine
    0024-5869TOUJEOinsulin glargine
    0024-5871TOUJEO Maxinsulin glargine

    Trademark Results [BASAGLAR]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    BASAGLAR
    BASAGLAR
    87752275 not registered Live/Pending
    Eli Lilly and Company
    2018-01-11
    BASAGLAR
    BASAGLAR
    86321101 not registered Dead/Abandoned
    Eli Lilly and Company
    2014-06-26
    BASAGLAR
    BASAGLAR
    86273009 not registered Dead/Abandoned
    Eli Lilly and Company
    2014-05-06
    BASAGLAR
    BASAGLAR
    85350709 4688972 Live/Registered
    Eli Lilly and Company
    2011-06-20

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