NDC 0024-5901

Praluent

Alirocumab

Praluent 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 Alirocumab.

Product ID0024-5901_29fff6da-cf37-4a75-bdc5-abd63f28bc71
NDC0024-5901
Product TypeHuman Prescription Drug
Proprietary NamePraluent
Generic NameAlirocumab
Dosage FormInjection, Solution
Route of AdministrationSUBCUTANEOUS
Marketing Start Date2015-07-24
Marketing CategoryBLA / BLA
Application NumberBLA125559
Labeler NameSanofi-Aventis U.S. LLC
Substance NameALIROCUMAB
Active Ingredient Strength75 mg/mL
Pharm ClassesPCSK9 Inhibitor [EPC],PCSK9 Inhibitors [MoA],Antibodies, Monoclonal [CS]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0024-5901-00

1 SYRINGE, GLASS in 1 CARTON (0024-5901-00) > 1 mL in 1 SYRINGE, GLASS
Marketing Start Date2015-07-24
NDC Exclude FlagN
Sample Package?Y

NDC SPL Data Element Entries

NDC 0024-5901-00 [00024590100]

Praluent INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA125559
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-07-24

NDC 0024-5901-02 [00024590102]

Praluent INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA125559
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2015-07-24

NDC 0024-5901-01 [00024590101]

Praluent INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA125559
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2015-07-24

Drug Details

Active Ingredients

IngredientStrength
ALIROCUMAB75 mg/mL

OpenFDA Data

SPL SET ID:446f6b5c-0dd4-44ff-9bc2-c2b41f2806b4
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1659161
  • 1659156
  • 1659165
  • 1659167
  • 1659177
  • 1659183
  • 1659182
  • 1659179
  • Pharmacological Class

    • PCSK9 Inhibitor [EPC]
    • PCSK9 Inhibitors [MoA]
    • Antibodies
    • Monoclonal [CS]

    NDC Crossover Matching brand name "Praluent" or generic name "Alirocumab"

    NDCBrand NameGeneric Name
    0024-5901Praluentalirocumab
    0024-5902Praluentalirocumab
    0024-5903Praluentalirocumab
    0024-5904Praluentalirocumab
    61755-020Praluentalirocumab
    72733-5901PraluentPraluent
    72733-5902PraluentPraluent
    61755-021PraluentPraluent

    Trademark Results [Praluent]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    PRALUENT
    PRALUENT
    86318389 4659691 Live/Registered
    SANOFI BIOTECHNOLOGY
    2014-06-24

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