NDC 0088-2219

Lantus Solostar

Insulin Glargine

Lantus Solostar 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 ID0088-2219_0a57f187-f101-4268-851f-7f20c7f708f9
NDC0088-2219
Product TypeHuman Prescription Drug
Proprietary NameLantus Solostar
Generic NameInsulin Glargine
Dosage FormInjection, Solution
Route of AdministrationSUBCUTANEOUS
Marketing Start Date2009-09-23
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 Through2022-12-31

Packaging

NDC 0088-2219-00

1 SYRINGE in 1 CARTON (0088-2219-00) > 3 mL in 1 SYRINGE
Marketing Start Date2009-09-23
NDC Exclude FlagN
Sample Package?Y

NDC SPL Data Element Entries

NDC 0088-2219-00 [00088221900]

Lantus Solostar INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA021081
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2009-09-23

NDC 0088-2219-01 [00088221901]

Lantus Solostar INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA021081
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2020-03-30

NDC 0088-2219-05 [00088221905]

Lantus Solostar INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA021081
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2009-09-23

Drug Details

Active Ingredients

IngredientStrength
INSULIN GLARGINE100 [iU]/mL

OpenFDA Data

SPL SET ID:d5e07a0c-7e14-4756-9152-9fea485d654a
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 Solostar" or generic name "Insulin Glargine"

    NDCBrand NameGeneric Name
    0088-2219Lantus Solostarinsulin glargine
    70518-1390Lantus SolostarLantus Solostar
    0088-5020Lantus SolostarLantus Solostar
    50090-1398Lantus SolostarLantus Solostar
    0002-7715BASAGLARInsulin glargine
    0002-8214BASAGLARInsulin glargine
    0088-2220Lantusinsulin glargine
    0024-5869TOUJEOinsulin glargine
    0024-5871TOUJEO Maxinsulin glargine

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