NDC 0002-8824

Humulin R U-500 KwikPen

Insulin Human

Humulin R U-500 KwikPen 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 Human.

• Product ID: 0002-8824_01dcc798-7fba-4eb7-af12-001ab92dee6e
• NDC: 0002-8824
• Product Type: Human Prescription Drug
• Proprietary Name: Humulin R U-500 KwikPen
• Generic Name: Insulin Human
• Dosage Form: Injection, Solution
• Route of Administration: SUBCUTANEOUS
• Marketing Start Date: 2015-12-29
• Marketing Category: NDA / NDA
• Application Number: NDA018780
• Labeler Name: Eli Lilly and Company
• Substance Name: INSULIN HUMAN
• Active Ingredient Strength: 500 [iU]/mL
• Pharm Classes: Insulin [EPC],Insulin [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 0002-8824-27

2 SYRINGE in 1 CARTON (0002-8824-27) > 3 mL in 1 SYRINGE

• Marketing Start Date: 2016-03-25
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0002-8824-59 [00002882459]

Humulin R U-500 KwikPen INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA018780
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2016-03-25
• Marketing End Date: 2016-03-25

NDC 0002-8824-27 [00002882427]

Humulin R U-500 KwikPen INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA018780
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2016-03-25

Drug Details

Active Ingredients

Ingredient	Strength
INSULIN HUMAN	500 [iU]/mL

OpenFDA Data

• SPL SET ID: b60e8dd0-1d48-4dc9-87fd-e14675255e8c
• Manufacturer:
  • Eli Lilly and Company
• UNII:
  • 1Y17CTI5SR
• RxNorm Concept Unique ID - RxCUI:
  • 249220
  • 1731317
  • 1731315
  • 351859
• UPC Code:
  • 0300028824276

Pharmacological Class

• Insulin [EPC]
• Insulin [CS]

NDC Crossover Matching brand name "Humulin R U-500 KwikPen" or generic name "Insulin Human"

NDC	Brand Name	Generic Name
47918-874	Afrezza	Insulin Human
0002-8215	Humulin	Insulin human
0002-8315	Humulin	Insulin human
0002-8501	Humulin	Insulin human
0002-8715	Humulin	Insulin human
0002-8803	Humulin	Insulin human
0002-8805	Humulin	Insulin human
0002-8824	Humulin	Insulin human
0338-0126	MYXREDLIN	insulin human