NDC 0024-5871

TOUJEO Max

Insulin Glargine

TOUJEO Max 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 ID0024-5871_032d4bb7-48bd-4751-9366-9ec46b7ff010
NDC0024-5871
Product TypeHuman Prescription Drug
Proprietary NameTOUJEO Max
Generic NameInsulin Glargine
Dosage FormInjection, Solution
Route of AdministrationSUBCUTANEOUS
Marketing Start Date2015-02-15
Marketing CategoryNDA / NDA
Application NumberNDA206538
Labeler NameSanofi-Aventis U.S. LLC
Substance NameINSULIN GLARGINE
Active Ingredient Strength300 U/mL
Pharm ClassesInsulin [Chemical/Ingredient],Insulin Analog [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0024-5871-01

1 SYRINGE in 1 CARTON (0024-5871-01) > 3 mL in 1 SYRINGE
Marketing Start Date2018-03-26
NDC Exclude FlagN
Sample Package?Y

NDC SPL Data Element Entries

NDC 0024-5871-00 [00024587100]

TOUJEO Max INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA206538
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2015-02-15

NDC 0024-5871-01 [00024587101]

TOUJEO Max INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA206538
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-03-26

NDC 0024-5871-02 [00024587102]

TOUJEO Max INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA206538
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-03-26

Drug Details

Active Ingredients

IngredientStrength
INSULIN GLARGINE300 U/mL

OpenFDA Data

SPL SET ID:c9561d96-124d-48ca-982f-0aa1575bff36
Manufacturer
UNII
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 Max" or generic name "Insulin Glargine"

    NDCBrand NameGeneric Name
    0024-5871TOUJEO Maxinsulin glargine
    50090-4177TOUJEO MaxTOUJEO Max
    0002-7715BASAGLARInsulin glargine
    0002-8214BASAGLARInsulin glargine
    0088-2220Lantusinsulin glargine
    0088-2219Lantus Solostarinsulin glargine
    0024-5869TOUJEOinsulin glargine

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.