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 ID: 0024-5901_29fff6da-cf37-4a75-bdc5-abd63f28bc71
• NDC: 0024-5901
• Product Type: Human Prescription Drug
• Proprietary Name: Praluent
• Generic Name: Alirocumab
• Dosage Form: Injection, Solution
• Route of Administration: SUBCUTANEOUS
• Marketing Start Date: 2015-07-24
• Marketing Category: BLA / BLA
• Application Number: BLA125559
• Labeler Name: Sanofi-Aventis U.S. LLC
• Substance Name: ALIROCUMAB
• Active Ingredient Strength: 75 mg/mL
• Pharm Classes: PCSK9 Inhibitor [EPC],PCSK9 Inhibitors [MoA],Antibodies, Monoclonal [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 0024-5901-00

1 SYRINGE, GLASS in 1 CARTON (0024-5901-00) > 1 mL in 1 SYRINGE, GLASS

• Marketing Start Date: 2015-07-24
• NDC Exclude Flag: N
• Sample Package?: Y

NDC SPL Data Element Entries

NDC 0024-5901-00 [00024590100]

Praluent INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA125559
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2015-07-24

NDC 0024-5901-02 [00024590102]

Praluent INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA125559
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2015-07-24

NDC 0024-5901-01 [00024590101]

Praluent INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA125559
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2015-07-24

Drug Details

Active Ingredients

Ingredient	Strength
ALIROCUMAB	75 mg/mL

OpenFDA Data

• SPL SET ID: 446f6b5c-0dd4-44ff-9bc2-c2b41f2806b4
• Manufacturer:
  • Sanofi-Aventis U.S. LLC
• UNII:
  • PP0SHH6V16
• 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"

NDC	Brand Name	Generic Name
0024-5901	Praluent	alirocumab
0024-5902	Praluent	alirocumab
0024-5903	Praluent	alirocumab
0024-5904	Praluent	alirocumab
61755-020	Praluent	alirocumab
72733-5901	Praluent	Praluent
72733-5902	Praluent	Praluent
61755-021	Praluent	Praluent