regadenoson

Generic: regadenoson

Labeler: gland pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name regadenoson
Generic Name regadenoson
Labeler gland pharma limited
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

regadenoson .08 mg/mL

Manufacturer
Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-175
Product ID 68083-175_549593f6-8cfc-4182-8f3c-a60870187d8f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207320
Listing Expiration 2026-12-31
Marketing Start 2022-07-12

Pharmacologic Class

Established (EPC)
adenosine receptor agonist [epc]
Mechanism of Action
adenosine receptor agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68083175
Hyphenated Format 68083-175

Supplemental Identifiers

UPC
0368083175108
UNII
2XLN4Y044H
NUI
N0000178375 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 ANDA207320 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • .08 mg/mL
source: ndc
Packaging
  • 10 VIAL in 1 CARTON (68083-175-10) / 5 mL in 1 VIAL (68083-175-01)
source: ndc

Packages (1)

68083-175-10 10 VIAL in 1 CARTON (68083-175-10) / 5 mL in 1 VIAL (68083-175-01)

Ingredients (1)

regadenoson (.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": "549593f6-8cfc-4182-8f3c-a60870187d8f", "openfda": {"nui": ["N0000178375", "N0000175788"], "upc": ["0368083175108"], "unii": ["2XLN4Y044H"], "spl_set_id": ["5e4109f0-4875-4f8e-b70d-4055b3a785a3"], "pharm_class_epc": ["Adenosine Receptor Agonist [EPC]"], "pharm_class_moa": ["Adenosine Receptor Agonists [MoA]"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (68083-175-10)  / 5 mL in 1 VIAL (68083-175-01)", "package_ndc": "68083-175-10", "marketing_start_date": "20220712"}], "brand_name": "Regadenoson", "product_id": "68083-175_549593f6-8cfc-4182-8f3c-a60870187d8f", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Adenosine Receptor Agonists [MoA]", "Pharmacologic Cardiac Stress Test Agent [EPC]"], "product_ndc": "68083-175", "generic_name": "Regadenoson", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Regadenoson", "active_ingredients": [{"name": "REGADENOSON", "strength": ".08 mg/mL"}], "application_number": "ANDA207320", "marketing_category": "ANDA", "marketing_start_date": "20220712", "listing_expiration_date": "20261231"}