NDC 0002-8213

Humalog Tempo Pen

Insulin Lispro

Humalog 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 Lispro.

Product ID0002-8213_13204abd-313e-4901-9cd8-62634c0f5966
NDC0002-8213
Product TypeHuman Prescription Drug
Proprietary NameHumalog Tempo Pen
Generic NameInsulin Lispro
Dosage FormInjection, Solution
Route of AdministrationSUBCUTANEOUS
Marketing Start Date2017-06-06
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 0002-8213-05

5 SYRINGE in 1 CARTON (0002-8213-05) > 3 mL in 1 SYRINGE (0002-8213-01)
Marketing Start Date2019-11-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0002-8213-05 [00002821305]

Humalog Tempo Pen INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA020563
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-11-15

NDC 0002-8213-01 [00002821301]

Humalog Tempo Pen INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA020563
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-06-06

Drug Details

Active Ingredients

IngredientStrength
INSULIN LISPRO100 [iU]/mL

Pharmacological Class

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

NDC Crossover Matching brand name "Humalog Tempo Pen" or generic name "Insulin Lispro"

NDCBrand NameGeneric Name
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

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