NDC 0024-5761

Soliqua 100/33

Insulin Glargine And Lixisenatide

Soliqua 100/33 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 Insulin Glargine; Lixisenatide.

• Product ID: 0024-5761_2cda9955-3325-4ac6-9815-1b7714ee41da
• NDC: 0024-5761
• Product Type: Human Prescription Drug
• Proprietary Name: Soliqua 100/33
• Generic Name: Insulin Glargine And Lixisenatide
• Dosage Form: Injection, Solution
• Route of Administration: SUBCUTANEOUS
• Marketing Start Date: 2016-11-21
• Marketing Category: NDA / NDA
• Application Number: NDA208673
• Labeler Name: Sanofi-Aventis U.S. LLC
• Substance Name: INSULIN GLARGINE; LIXISENATIDE
• Active Ingredient Strength: 100 U/mL; ug/mL
• Pharm Classes: Insulin [Chemical/Ingredient],Insulin Analog [EPC],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: 2021-12-31

Packaging

NDC 0024-5761-01

1 SYRINGE in 1 CARTON (0024-5761-01) > 3 mL in 1 SYRINGE

• Marketing Start Date: 2016-11-21
• NDC Exclude Flag: N
• Sample Package?: Y

NDC SPL Data Element Entries

NDC 0024-5761-05 [00024576105]

Soliqua 100/33 INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA208673
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2016-11-21

NDC 0024-5761-01 [00024576101]

Soliqua 100/33 INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA208673
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2016-11-21

NDC 0024-5761-02 [00024576102]

Soliqua 100/33 INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA208673
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2020-03-30

Drug Details

Active Ingredients

Ingredient	Strength
INSULIN GLARGINE	100 U/mL

OpenFDA Data

• SPL SET ID: 4bba538b-cf7c-4310-ae8f-cb711ed21bcc
• Manufacturer:
  • Sanofi-Aventis U.S. LLC
• UNII:
  • 74O62BB01U
  • 2ZM8CX04RZ
• RxNorm Concept Unique ID - RxCUI:
  • 1858995
  • 1859000
• PHarm Class EPC:
  • Insulin Analog [EPC]
• NUI Code:
  • N0000175453
  • N0000004931

Pharmacological Class

• Insulin [Chemical/Ingredient]
• Insulin Analog [EPC]
• GLP-1 Receptor Agonist [EPC]
• Glucagon-Like Peptide 1 [CS]
• Glucagon-like Peptide-1 (GLP-1) Agonists [MoA]