NDC 0024-5747

ADLYXIN

Lixisenatide

ADLYXIN is a Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Sanofi-aventis U.s. Llc. The primary component is Lixisenatide.

• Product ID: 0024-5747_46bfa5a6-3b18-46da-95d0-0a7ac6983cb1
• NDC: 0024-5747
• Product Type: Human Prescription Drug
• Proprietary Name: ADLYXIN
• Generic Name: Lixisenatide
• Dosage Form: Injection, Solution
• Route of Administration: SUBCUTANEOUS
• Marketing Start Date: 2016-07-27
• Marketing Category: BLA / NDA
• Application Number: BLA208471
• Labeler Name: sanofi-aventis U.S. LLC
• Substance Name: LIXISENATIDE
• Active Ingredient Strength: 100 ug/mL
• Pharm Classes: GLP-1 Receptor Agonist [EPC],Glucagon-Like Peptide 1 [CS],Glucagon-like Peptide-1 (GLP-1) Agonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 0024-5747-02

2 SYRINGE in 1 CARTON (0024-5747-02) > 3 mL in 1 SYRINGE

• Marketing Start Date: 2016-07-27
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0024-5747-02 [00024574702]

ADLYXIN INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA208471
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2016-07-27

Drug Details

Active Ingredients

Ingredient	Strength
LIXISENATIDE	100 ug/mL

OpenFDA Data

• SPL SET ID: 1727cc16-4f86-4f13-b8b5-804d4984fa8c
• Manufacturer:
  • Sanofi-Aventis U.S. LLC
• UNII:
  • 74O62BB01U
• RxNorm Concept Unique ID - RxCUI:
  • 1803894
  • 1803896
  • 1803902
  • 1803903
  • 1803892
  • 1803893

Pharmacological Class

• GLP-1 Receptor Agonist [EPC]
• Glucagon-Like Peptide 1 [CS]
• Glucagon-like Peptide-1 (GLP-1) Agonists [MoA]

NDC Crossover Matching brand name "ADLYXIN" or generic name "Lixisenatide"

NDC	Brand Name	Generic Name
0024-5745	ADLYXIN	Lixisenatide
0024-5747	ADLYXIN	Lixisenatide