Package 10135-803-51

Brand: regadenoson

Generic: regadenoson
NDC Package

Package Facts

Identity

Package NDC 10135-803-51
Digits Only 1013580351
Product NDC 10135-803
Description

1 SYRINGE in 1 CARTON (10135-803-51) / 5 mL in 1 SYRINGE

Marketing

Marketing Status
Marketed Since 2024-08-22
Brand regadenoson
Generic regadenoson
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["INTRAVENOUS"], "spl_id": "b35f97f9-3052-4431-893e-ec9218aab105", "openfda": {"nui": ["N0000178375", "N0000175788"], "upc": ["0310135803514"], "unii": ["2XLN4Y044H"], "spl_set_id": ["843bfba9-47de-4d76-843a-997bb4564f6e"], "pharm_class_epc": ["Adenosine Receptor Agonist [EPC]"], "pharm_class_moa": ["Adenosine Receptor Agonists [MoA]"], "manufacturer_name": ["Marlex Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 SYRINGE in 1 CARTON (10135-803-51)  / 5 mL in 1 SYRINGE", "package_ndc": "10135-803-51", "marketing_start_date": "20240822"}], "brand_name": "Regadenoson", "product_id": "10135-803_b35f97f9-3052-4431-893e-ec9218aab105", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Adenosine Receptor Agonists [MoA]", "Pharmacologic Cardiac Stress Test Agent [EPC]"], "product_ndc": "10135-803", "generic_name": "Regadenoson", "labeler_name": "Marlex Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Regadenoson", "active_ingredients": [{"name": "REGADENOSON", "strength": ".08 mg/mL"}], "application_number": "ANDA218054", "marketing_category": "ANDA", "marketing_start_date": "20240822", "listing_expiration_date": "20261231"}