NDC 70518-1389

Humalog KwikPen

Insulin Lispro

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

• Product ID: 70518-1389_750ae475-5bd2-0f90-e053-2991aa0afbbb
• NDC: 70518-1389
• Product Type: Human Prescription Drug
• Proprietary Name: Humalog KwikPen
• Generic Name: Insulin Lispro
• Dosage Form: Injection, Solution
• Route of Administration: INTRAVENOUS; SUBCUTANEOUS
• Marketing Start Date: 2018-08-28
• Marketing Category: NDA / NDA
• Application Number: NDA020563
• Labeler Name: REMEDYREPACK INC.
• 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: 2019-12-31

Packaging

NDC 70518-1389-0

5 SYRINGE in 1 CARTON (70518-1389-0) > 3 mL in 1 SYRINGE

• Marketing Start Date: 2018-08-28
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 70518-1389-0 [70518138900]

Humalog KwikPen INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA020563
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2018-08-28
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
INSULIN LISPRO	100 [iU]/mL

OpenFDA Data

• SPL SET ID: e598b18a-85e7-4123-b35f-c1b99ea49ef9
• Manufacturer:
  • REMEDYREPACK INC.
• UNII:
  • GFX7QIS1II
• RxNorm Concept Unique ID - RxCUI:
  • 1652639
  • 1652640
• PHarm Class EPC:
  • Insulin Analog [EPC]
• NUI Code:
  • N0000175453
  • N0000004931

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
70518-1389	Humalog KwikPen	Humalog KwikPen
50090-1663	Humalog KwikPen	Humalog KwikPen
0002-8799	Humalog KwikPen	Humalog KwikPen
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