Regadenoson

Generic: REGADENOSON ANHYDROUS

Labeler: GE Healthcare Inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive

Drug Facts

Product Profile

Brand Name Regadenoson
Generic Name REGADENOSON ANHYDROUS
Labeler GE Healthcare Inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

REGADENOSON ANHYDROUS .08 mg/mL

Identifiers & Regulatory

Product NDC 0407-5034
Product ID 0407-5034_76eb1be4-0ef4-4b64-8e9b-48f15c1cc451
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215955
Marketing Start 2025-03-28
Marketing End 2026-02-16

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 04075034
Hyphenated Format 0407-5034

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 Regadenoson (source: ndc)
Generic Name REGADENOSON ANHYDROUS (source: ndc)
Application Number ANDA215955 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • .08 mg/mL
source: ndc
Packaging
  • 10 SYRINGE, PLASTIC in 1 BOX (0407-5034-05) / 5 mL in 1 SYRINGE, PLASTIC
source: ndc

Packages (1)

0407-5034-05 10 SYRINGE, PLASTIC in 1 BOX (0407-5034-05) / 5 mL in 1 SYRINGE, PLASTIC

Ingredients (1)

REGADENOSON ANHYDROUS (.08 mg/mL)

Linked Drug Pages (1)

Regadenoson ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "76eb1be4-0ef4-4b64-8e9b-48f15c1cc451", "openfda": {"nui": ["N0000193963", "N0000175788"], "unii": ["7AXV542LZ4"], "spl_set_id": ["f536b1d5-a453-42a5-81d2-2571c2e04ead"], "pharm_class_epc": ["Pharmacologic Cardiac Stress Test Agent [EPC]"], "pharm_class_moa": ["Adenosine Receptor Agonists [MoA]"], "manufacturer_name": ["GE Healthcare Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 SYRINGE, PLASTIC in 1 BOX (0407-5034-05)  / 5 mL in 1 SYRINGE, PLASTIC", "package_ndc": "0407-5034-05", "marketing_end_date": "20260216", "marketing_start_date": "20250328"}], "brand_name": "Regadenoson", "product_id": "0407-5034_76eb1be4-0ef4-4b64-8e9b-48f15c1cc451", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Adenosine Receptor Agonists [MoA]", "Pharmacologic Cardiac Stress Test Agent [EPC]"], "product_ndc": "0407-5034", "generic_name": "REGADENOSON ANHYDROUS", "labeler_name": "GE Healthcare Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Regadenoson", "active_ingredients": [{"name": "REGADENOSON ANHYDROUS", "strength": ".08 mg/mL"}], "application_number": "ANDA215955", "marketing_category": "ANDA", "marketing_end_date": "20260216", "marketing_start_date": "20250328"}