NDC 0024-5869

TOUJEO

Insulin Glargine

TOUJEO 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.

• Product ID: 0024-5869_032d4bb7-48bd-4751-9366-9ec46b7ff010
• NDC: 0024-5869
• Product Type: Human Prescription Drug
• Proprietary Name: TOUJEO
• Generic Name: Insulin Glargine
• Dosage Form: Injection, Solution
• Route of Administration: SUBCUTANEOUS
• Marketing Start Date: 2015-02-15
• Marketing Category: NDA / NDA
• Application Number: NDA206538
• Labeler Name: Sanofi-Aventis U.S. LLC
• Substance Name: INSULIN GLARGINE
• Active Ingredient Strength: 300 U/mL
• Pharm Classes: Insulin [Chemical/Ingredient],Insulin Analog [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0024-5869-00

1 SYRINGE in 1 CARTON (0024-5869-00) > 1.5 mL in 1 SYRINGE

• Marketing Start Date: 2015-02-15
• NDC Exclude Flag: N
• Sample Package?: Y

NDC SPL Data Element Entries

NDC 0024-5869-00 [00024586900]

TOUJEO INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA206538
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2015-02-15

NDC 0024-5869-05 [00024586905]

TOUJEO INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA206538
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2015-02-15
• Marketing End Date: 2018-03-26

NDC 0024-5869-03 [00024586903]

TOUJEO INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA206538
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2015-02-15

NDC 0024-5869-01 [00024586901]

TOUJEO INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA206538
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2015-02-15

Drug Details

Active Ingredients

Ingredient	Strength
INSULIN GLARGINE	300 U/mL

OpenFDA Data

• SPL SET ID: c9561d96-124d-48ca-982f-0aa1575bff36
• Manufacturer:
  • Sanofi-Aventis U.S. LLC
• UNII:
  • 2ZM8CX04RZ
• RxNorm Concept Unique ID - RxCUI:
  • 1604544
  • 2002420
  • 1604539
  • 2002419
• PHarm Class EPC:
  • Insulin Analog [EPC]
• NUI Code:
  • N0000175453
  • N0000004931

Pharmacological Class

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

NDC Crossover Matching brand name "TOUJEO" or generic name "Insulin Glargine"

NDC	Brand Name	Generic Name
0024-5869	TOUJEO	insulin glargine
50090-2193	TOUJEO	TOUJEO
0002-7715	BASAGLAR	Insulin glargine
0002-8214	BASAGLAR	Insulin glargine
0088-2220	Lantus	insulin glargine
0088-2219	Lantus Solostar	insulin glargine
0024-5871	TOUJEO Max	insulin glargine