praluent

Generic: alirocumab

Labeler: regeneron pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name praluent
Generic Name alirocumab
Labeler regeneron pharmaceuticals, inc.
Dosage Form INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients

alirocumab 150 mg/mL

Manufacturer
Regeneron Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 61755-021
Product ID 61755-021_ad540294-d141-4655-a97b-abc9ae2795a3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA125559
Listing Expiration 2026-12-31
Marketing Start 2020-12-01

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 61755021
Hyphenated Format 61755-021

Supplemental Identifiers

RxCUI
1659156 1659161 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
  • 150 mg/mL
source: ndc
Packaging
  • 1 SYRINGE, GLASS in 1 CARTON (61755-021-01) / 1 mL in 1 SYRINGE, GLASS
  • 2 SYRINGE, GLASS in 1 CARTON (61755-021-02) / 1 mL in 1 SYRINGE, GLASS
  • 1 SYRINGE, GLASS in 1 CARTON (61755-021-04) / 1 mL in 1 SYRINGE, GLASS
source: ndc

Packages (3)

61755-021-01 1 SYRINGE, GLASS in 1 CARTON (61755-021-01) / 1 mL in 1 SYRINGE, GLASS 61755-021-02 2 SYRINGE, GLASS in 1 CARTON (61755-021-02) / 1 mL in 1 SYRINGE, GLASS 61755-021-04 1 SYRINGE, GLASS in 1 CARTON (61755-021-04) / 1 mL in 1 SYRINGE, GLASS

Ingredients (1)

alirocumab (150 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": "ad540294-d141-4655-a97b-abc9ae2795a3", "openfda": {"nui": ["N0000191731", "N0000191730", "M0001357"], "unii": ["PP0SHH6V16"], "rxcui": ["1659156", "1659161", "1659182", "1659183"], "spl_set_id": ["7bcfbac2-e8ac-4569-8edc-bcde3b1fd172"], "pharm_class_cs": ["Antibodies, Monoclonal [CS]"], "pharm_class_epc": ["PCSK9 Inhibitor [EPC]"], "pharm_class_moa": ["PCSK9 Inhibitors [MoA]"], "manufacturer_name": ["Regeneron Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 SYRINGE, GLASS in 1 CARTON (61755-021-01)  / 1 mL in 1 SYRINGE, GLASS", "package_ndc": "61755-021-01", "marketing_start_date": "20201201"}, {"sample": false, "description": "2 SYRINGE, GLASS in 1 CARTON (61755-021-02)  / 1 mL in 1 SYRINGE, GLASS", "package_ndc": "61755-021-02", "marketing_start_date": "20201201"}, {"sample": true, "description": "1 SYRINGE, GLASS in 1 CARTON (61755-021-04)  / 1 mL in 1 SYRINGE, GLASS", "package_ndc": "61755-021-04", "marketing_start_date": "20201201"}], "brand_name": "Praluent", "product_id": "61755-021_ad540294-d141-4655-a97b-abc9ae2795a3", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Antibodies", "Monoclonal [CS]", "PCSK9 Inhibitor [EPC]", "PCSK9 Inhibitors [MoA]"], "product_ndc": "61755-021", "generic_name": "alirocumab", "labeler_name": "Regeneron Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Praluent", "active_ingredients": [{"name": "ALIROCUMAB", "strength": "150 mg/mL"}], "application_number": "BLA125559", "marketing_category": "BLA", "marketing_start_date": "20201201", "listing_expiration_date": "20261231"}