Package 61755-021-04

Brand: praluent

Generic: alirocumab
NDC Package Sample

Package Facts

Identity

Package NDC 61755-021-04
Digits Only 6175502104
Product NDC 61755-021
Description

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

Marketing

Marketing Status
Marketed Since 2020-12-01
Brand praluent
Generic alirocumab
Sample Package Yes

Linked Drug Pages (1)

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"}