regadenoson

Generic: regadenoson

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name regadenoson
Generic Name regadenoson
Labeler hikma pharmaceuticals usa inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

regadenoson anhydrous .08 mg/mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0641-6253
Product ID 0641-6253_6d9e653e-94ea-444c-85cf-f24cbfb74c65
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215827
Listing Expiration 2026-12-31
Marketing Start 2023-04-03

Pharmacologic Class

Established (EPC)
pharmacologic cardiac stress test agent [epc]
Mechanism of Action
adenosine receptor agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 06416253
Hyphenated Format 0641-6253

Supplemental Identifiers

UNII
7AXV542LZ4
NUI
N0000193963 N0000175788

Packaging Origin

Original Packager
true

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 (source: ndc)
Application Number ANDA215827 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • .08 mg/mL
source: ndc
Packaging
  • 1 SYRINGE, PLASTIC in 1 CARTON (0641-6253-01) / 5 mL in 1 SYRINGE, PLASTIC
source: ndc

Packages (1)

0641-6253-01 1 SYRINGE, PLASTIC in 1 CARTON (0641-6253-01) / 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": "6d9e653e-94ea-444c-85cf-f24cbfb74c65", "openfda": {"nui": ["N0000193963", "N0000175788"], "unii": ["7AXV542LZ4"], "spl_set_id": ["9e48b407-1ce3-461d-b48e-de183802de25"], "pharm_class_epc": ["Pharmacologic Cardiac Stress Test Agent [EPC]"], "pharm_class_moa": ["Adenosine Receptor Agonists [MoA]"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 SYRINGE, PLASTIC in 1 CARTON (0641-6253-01)  / 5 mL in 1 SYRINGE, PLASTIC", "package_ndc": "0641-6253-01", "marketing_start_date": "20230403"}], "brand_name": "Regadenoson", "product_id": "0641-6253_6d9e653e-94ea-444c-85cf-f24cbfb74c65", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Adenosine Receptor Agonists [MoA]", "Pharmacologic Cardiac Stress Test Agent [EPC]"], "product_ndc": "0641-6253", "generic_name": "Regadenoson", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Regadenoson", "active_ingredients": [{"name": "REGADENOSON ANHYDROUS", "strength": ".08 mg/mL"}], "application_number": "ANDA215827", "marketing_category": "ANDA", "marketing_start_date": "20230403", "listing_expiration_date": "20261231"}