Package 83831-105-01

Brand: posfrea

Generic: palonosetron
NDC Package

Package Facts

Identity

Package NDC 83831-105-01
Digits Only 8383110501
Product NDC 83831-105
Product ID 83831-105_2f9cbcbc-86ee-49e4-a98a-d7fa286a32b8
Description

1 VIAL, SINGLE-DOSE in 1 CARTON (83831-105-01) / 5 mL in 1 VIAL, SINGLE-DOSE

Marketing

Marketing Status
Marketed Since 2024-09-30
Brand posfrea
Generic palonosetron
Sample Package No

Linked Drug Pages (1)

posfrea ndc-match (0.95)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "2f9cbcbc-86ee-49e4-a98a-d7fa286a32b8", "openfda": {"upc": ["0383831105015"], "unii": ["23310D4I19"], "rxcui": ["1728050", "1728055", "2688837", "2688839"], "spl_set_id": ["13a201ba-c86d-48c5-a0e1-a3e0b4e6a2a7"], "manufacturer_name": ["Avyxa Pharma, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (83831-105-01)  / 5 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "83831-105-01", "marketing_start_date": "20240930"}], "brand_name": "posfrea", "product_id": "83831-105_2f9cbcbc-86ee-49e4-a98a-d7fa286a32b8", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Serotonin 3 Receptor Antagonists [MoA]", "Serotonin-3 Receptor Antagonist [EPC]"], "product_ndc": "83831-105", "generic_name": "palonosetron", "labeler_name": "Avyxa Pharma, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "posfrea", "active_ingredients": [{"name": "PALONOSETRON HYDROCHLORIDE", "strength": ".25 mg/5mL"}], "application_number": "NDA203050", "marketing_category": "NDA", "marketing_start_date": "20240930", "listing_expiration_date": "20261231"}