Package 0310-9400-01

Brand: wainua

Generic: eplontersen
NDC Package

Package Facts

Identity

Package NDC 0310-9400-01
Digits Only 0310940001
Product NDC 0310-9400
Description

1 SYRINGE, GLASS in 1 CARTON (0310-9400-01) / .8 mL in 1 SYRINGE, GLASS

Marketing

Marketing Status
Marketed Since 2023-12-21
Brand wainua
Generic eplontersen
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["SUBCUTANEOUS"], "spl_id": "97ea43e5-c637-4d33-9483-514e8d06af80", "openfda": {"nui": ["N0000193849", "N0000191626", "M0025055", "N0000008852", "N0000009531"], "unii": ["0GRZ0F5XJ6"], "rxcui": ["2671944", "2671950"], "spl_set_id": ["d7dcb847-71dd-4fff-82d0-d43a465fc096"], "pharm_class_cs": ["Oligonucleotides, Antisense [CS]"], "pharm_class_pe": ["Decreased RNA Integrity [PE]", "Increased Protein Breakdown [PE]"], "pharm_class_epc": ["Transthyretin-directed RNA Interaction [EPC]", "Antisense Oligonucleotide [EPC]"], "manufacturer_name": ["AstraZeneca Pharmaceuticals LP"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 SYRINGE, GLASS in 1 CARTON (0310-9400-01)  / .8 mL in 1 SYRINGE, GLASS", "package_ndc": "0310-9400-01", "marketing_start_date": "20231221"}], "brand_name": "WAINUA", "product_id": "0310-9400_97ea43e5-c637-4d33-9483-514e8d06af80", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Antisense Oligonucleotide [EPC]", "Decreased RNA Integrity [PE]", "Increased Protein Breakdown [PE]", "Oligonucleotides", "Antisense [CS]", "Transthyretin-directed RNA Interaction [EPC]"], "product_ndc": "0310-9400", "generic_name": "EPLONTERSEN", "labeler_name": "AstraZeneca Pharmaceuticals LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "WAINUA", "active_ingredients": [{"name": "EPLONTERSEN", "strength": "45 mg/.8mL"}], "application_number": "NDA217388", "marketing_category": "NDA", "marketing_start_date": "20231221", "listing_expiration_date": "20271231"}