NDC 0088-5021

Lantus

Insulin Glargine

Lantus 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 ID0088-5021_2c27943b-b9d7-4838-8b39-618aab8b54fa
NDC0088-5021
Product TypeHuman Prescription Drug
Proprietary NameLantus
Generic NameInsulin Glargine
Dosage FormInjection, Solution
Route of AdministrationSUBCUTANEOUS
Marketing Start Date2017-06-04
Marketing CategoryBLA / NDA
Application NumberBLA021081
Labeler Namesanofi-aventis U.S. LLC
Substance NameINSULIN GLARGINE
Active Ingredient Strength100 [iU]/mL
Pharm ClassesInsulin [Chemical/Ingredient],Insulin Analog [EPC]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0088-5021-01

1 VIAL, GLASS in 1 PACKAGE (0088-5021-01) > 10 mL in 1 VIAL, GLASS
Marketing Start Date2017-06-04
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0088-5021-01 [00088502101]

Lantus INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA021081
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2017-06-04

Drug Details

Active Ingredients

IngredientStrength
INSULIN GLARGINE100 [iU]/mL

OpenFDA Data

SPL SET ID:6328c99d-d75f-43ef-b19e-7e71f91e57f6
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 311041
  • 847230
  • 847232
  • 285018
  • PHarm Class EPC
  • Insulin Analog [EPC]
  • NUI Code
  • N0000175453
  • N0000004931
  • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    0088-2220Lantusinsulin glargine
    70518-1865LantusLantus
    0088-5021LantusLantus
    50090-0876LantusLantus
    55045-3685LantusLantus
    64725-2220LantusLantus
    0002-7715BASAGLARInsulin glargine
    0002-8214BASAGLARInsulin glargine
    0088-2219Lantus Solostarinsulin glargine
    0024-5869TOUJEOinsulin glargine
    0024-5871TOUJEO Maxinsulin glargine

    Trademark Results [Lantus]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    LANTUS
    LANTUS
    87583887 not registered Live/Pending
    SIG SAUER Inc.
    2017-08-25
    LANTUS
    LANTUS
    74436868 2183182 Live/Registered
    SANOFI-AVENTIS DEUTSCHLAND GMBH
    1993-09-17

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