NDC 0002-8799

Humalog KwikPen

Insulin Lispro

Humalog KwikPen is a Intravenous; Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Eli Lilly And Company. The primary component is Insulin Lispro.

Product ID0002-8799_13204abd-313e-4901-9cd8-62634c0f5966
NDC0002-8799
Product TypeHuman Prescription Drug
Proprietary NameHumalog KwikPen
Generic NameInsulin Lispro
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS; SUBCUTANEOUS
Marketing Start Date2007-09-06
Marketing CategoryNDA / NDA
Application NumberNDA020563
Labeler NameEli Lilly and Company
Substance NameINSULIN LISPRO
Active Ingredient Strength100 [iU]/mL
Pharm ClassesInsulin [Chemical/Ingredient],Insulin Analog [EPC]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0002-8799-59

5 SYRINGE in 1 CARTON (0002-8799-59) > 3 mL in 1 SYRINGE (0002-8799-01)
Marketing Start Date2008-01-16
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0002-8799-01 [00002879901]

Humalog KwikPen INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA020563
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2007-09-06

NDC 0002-8799-99 [00002879999]

Humalog KwikPen INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA020563
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-01-16
Marketing End Date2020-01-31

NDC 0002-8799-59 [00002879959]

Humalog KwikPen INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA020563
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2008-01-16

NDC 0002-8799-61 [00002879961]

Humalog KwikPen INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA020563
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-10-01

Drug Details

Active Ingredients

IngredientStrength
INSULIN LISPRO100 [iU]/mL

OpenFDA Data

SPL SET ID:c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1652639
  • 1926331
  • 1652644
  • 1652640
  • 242120
  • 1652242
  • 1652646
  • 865098
  • 1652239
  • 1926332
  • PHarm Class EPC
  • Insulin Analog [EPC]
  • UPC Code
  • 0300027510019
  • NUI Code
  • N0000175453
  • N0000004931
  • Pharmacological Class

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

    NDC Crossover Matching brand name "Humalog KwikPen" or generic name "Insulin Lispro"

    NDCBrand NameGeneric Name
    70518-1389Humalog KwikPenHumalog KwikPen
    50090-1663Humalog KwikPenHumalog KwikPen
    0002-8799Humalog KwikPenHumalog KwikPen
    0002-7510HumalogInsulin lispro
    0002-7511HumalogInsulin lispro
    0002-7512HumalogInsulin lispro
    0002-7516HumalogInsulin lispro
    0002-7712HumalogInsulin lispro
    0002-7714HumalogInsulin lispro

    Trademark Results [Humalog]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    HUMALOG
    HUMALOG
    74314093 1963572 Live/Registered
    Eli Lilly and Company
    1992-09-15

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.