NDC 0088-2500

Apidra

Insulin Glulisine

Apidra is a Intravenous; Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Sanofi-aventis U.s. Llc. The primary component is Insulin Glulisine.

• Product ID: 0088-2500_286b7639-8fe3-4fbd-928f-a4fde7746f43
• NDC: 0088-2500
• Product Type: Human Prescription Drug
• Proprietary Name: Apidra
• Generic Name: Insulin Glulisine
• Dosage Form: Injection, Solution
• Route of Administration: INTRAVENOUS; SUBCUTANEOUS
• Marketing Start Date: 2009-02-24
• Marketing Category: BLA / NDA
• Application Number: BLA021629
• Labeler Name: sanofi-aventis U.S. LLC
• Substance Name: INSULIN GLULISINE
• Active Ingredient Strength: 100 [iU]/mL
• Pharm Classes: Insulin [Chemical/Ingredient],Insulin Analog [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 0088-2500-33

1 VIAL, GLASS in 1 CARTON (0088-2500-33) > 10 mL in 1 VIAL, GLASS

• Marketing Start Date: 2009-02-24
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0088-2500-52 [00088250052]

Apidra INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA021629
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2009-02-24
• Marketing End Date: 2013-10-03

NDC 0088-2500-33 [00088250033]

Apidra INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA021629
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2009-02-24

NDC 0088-2500-34 [00088250034]

Apidra INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA021629
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2009-02-24

Drug Details

Active Ingredients

Ingredient	Strength
INSULIN GLULISINE	100 [iU]/mL

OpenFDA Data

• SPL SET ID: e7af6a7a-8046-4fb4-9979-4ec4230b23aa
• Manufacturer:
  • Sanofi-Aventis U.S. LLC
• UNII:
  • 7XIY785AZD
• RxNorm Concept Unique ID - RxCUI:
  • 485210
  • 803194
  • 847261
  • 847259
• PHarm Class EPC:
  • Insulin Analog [EPC]
• NUI Code:
  • N0000175453
  • N0000004931

Pharmacological Class

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

NDC Crossover Matching brand name "Apidra" or generic name "Insulin Glulisine"

NDC	Brand Name	Generic Name
0088-2500	Apidra	insulin glulisine
0088-2502	Apidra SoloStar	insulin glulisine