praluent

Generic: alirocumab

Labeler: sanofi-aventis u.s. llc
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name praluent
Generic Name alirocumab
Labeler sanofi-aventis u.s. llc
Dosage Form INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients

alirocumab 75 mg/mL

Manufacturer
Sanofi-Aventis U.S. LLC

Identifiers & Regulatory

Product NDC 0024-5901
Product ID 0024-5901_4b8a5125-bbdb-45dd-bcd3-2f5e030e4dc6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA125559
Listing Expiration 2026-12-31
Marketing Start 2015-07-24

Pharmacologic Class

Established (EPC)
pcsk9 inhibitor [epc]
Mechanism of Action
pcsk9 inhibitors [moa]
Chemical Structure
antibodies, monoclonal [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00245901
Hyphenated Format 0024-5901

Supplemental Identifiers

RxCUI
1659156 1659161 1659165 1659167 1659177 1659179 1659182 1659183
UNII
PP0SHH6V16
NUI
N0000191731 N0000191730 M0001357

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name praluent (source: ndc)
Generic Name alirocumab (source: ndc)
Application Number BLA125559 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 75 mg/mL
source: ndc
Packaging
  • 1 SYRINGE, GLASS in 1 CARTON (0024-5901-00) / 1 mL in 1 SYRINGE, GLASS
  • 1 SYRINGE, GLASS in 1 CARTON (0024-5901-01) / 1 mL in 1 SYRINGE, GLASS
source: ndc

Packages (2)

0024-5901-00 1 SYRINGE, GLASS in 1 CARTON (0024-5901-00) / 1 mL in 1 SYRINGE, GLASS 0024-5901-01 1 SYRINGE, GLASS in 1 CARTON (0024-5901-01) / 1 mL in 1 SYRINGE, GLASS

Ingredients (1)

alirocumab (75 mg/mL)

Linked Drug Pages (1)

Praluent ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "4b8a5125-bbdb-45dd-bcd3-2f5e030e4dc6", "openfda": {"nui": ["N0000191731", "N0000191730", "M0001357"], "unii": ["PP0SHH6V16"], "rxcui": ["1659156", "1659161", "1659165", "1659167", "1659177", "1659179", "1659182", "1659183"], "spl_set_id": ["446f6b5c-0dd4-44ff-9bc2-c2b41f2806b4"], "pharm_class_cs": ["Antibodies, Monoclonal [CS]"], "pharm_class_epc": ["PCSK9 Inhibitor [EPC]"], "pharm_class_moa": ["PCSK9 Inhibitors [MoA]"], "manufacturer_name": ["Sanofi-Aventis U.S. LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": true, "description": "1 SYRINGE, GLASS in 1 CARTON (0024-5901-00)  / 1 mL in 1 SYRINGE, GLASS", "package_ndc": "0024-5901-00", "marketing_start_date": "20150724"}, {"sample": false, "description": "1 SYRINGE, GLASS in 1 CARTON (0024-5901-01)  / 1 mL in 1 SYRINGE, GLASS", "package_ndc": "0024-5901-01", "marketing_start_date": "20150724"}], "brand_name": "Praluent", "product_id": "0024-5901_4b8a5125-bbdb-45dd-bcd3-2f5e030e4dc6", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Antibodies", "Monoclonal [CS]", "PCSK9 Inhibitor [EPC]", "PCSK9 Inhibitors [MoA]"], "product_ndc": "0024-5901", "generic_name": "alirocumab", "labeler_name": "Sanofi-Aventis U.S. LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Praluent", "active_ingredients": [{"name": "ALIROCUMAB", "strength": "75 mg/mL"}], "application_number": "BLA125559", "marketing_category": "BLA", "marketing_start_date": "20150724", "listing_expiration_date": "20261231"}