NDC 0002-8233

Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25 KwikPen

Insulin Lispro

Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25 KwikPen is a Subcutaneous Injection, Suspension in the Human Prescription Drug category. It is labeled and distributed by Eli Lilly And Company. The primary component is Insulin Lispro.

• Product ID: 0002-8233_14062960-5954-4bb0-b1b3-66322c8eec8a
• NDC: 0002-8233
• Product Type: Human Prescription Drug
• Proprietary Name: Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25 KwikPen
• Generic Name: Insulin Lispro
• Dosage Form: Injection, Suspension
• Route of Administration: SUBCUTANEOUS
• Marketing Start Date: 2020-02-12
• Marketing Category: BLA / NDA AUTHORIZED GENERIC
• Application Number: BLA021017
• Labeler Name: Eli Lilly and Company
• Substance Name: INSULIN LISPRO
• Active Ingredient Strength: 100 [iU]/mL
• Pharm Classes: Insulin [Chemical/Ingredient],Insulin Analog [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 0002-8233-05

5 SYRINGE in 1 CARTON (0002-8233-05) > 3 mL in 1 SYRINGE (0002-8233-01)

• Marketing Start Date: 2020-02-12
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0002-8233-01 [00002823301]

Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25 KwikPen INJECTION, SUSPENSION

• Marketing Category: NDA authorized generic
• Application Number: NDA021017
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2020-03-16

NDC 0002-8233-05 [00002823305]

Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25 KwikPen INJECTION, SUSPENSION

• Marketing Category: NDA authorized generic
• Application Number: NDA021017
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2020-02-12

Drug Details

Active Ingredients

Ingredient	Strength
INSULIN LISPRO	100 [iU]/mL

OpenFDA Data

• SPL SET ID: e49f701d-c19f-4cb2-b63f-01a917b33abc
• Manufacturer:
  • Eli Lilly and Company
• UNII:
  • GFX7QIS1II
• RxNorm Concept Unique ID - RxCUI:
  • 847252
• PHarm Class EPC:
  • Insulin Analog [EPC]
• NUI Code:
  • N0000175453
  • N0000004931

Pharmacological Class

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

NDC Crossover Matching brand name "Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25 KwikPen" or generic name "Insulin Lispro"

NDC	Brand Name	Generic Name
0002-7510	Humalog	Insulin lispro
0002-7511	Humalog	Insulin lispro
0002-7512	Humalog	Insulin lispro
0002-7516	Humalog	Insulin lispro
0002-7712	Humalog	Insulin lispro
0002-7714	Humalog	Insulin lispro