regadenoson

Generic: regadenoson

Labeler: dr. reddy's laboratories inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name regadenoson
Generic Name regadenoson
Labeler dr. reddy's laboratories inc.
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

regadenoson anhydrous .08 mg/mL

Manufacturer
Dr. Reddy's Laboratories Inc.

Identifiers & Regulatory

Product NDC 43598-616
Product ID 43598-616_4b43c865-fcdb-4e57-30a4-871e37e0e593
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213210
Listing Expiration 2026-12-31
Marketing Start 2023-04-23

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 43598616
Hyphenated Format 43598-616

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 ANDA213210 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • .08 mg/mL
source: ndc
Packaging
  • 5 mL in 1 CARTON (43598-616-11)
source: ndc

Packages (1)

43598-616-11 5 mL in 1 CARTON (43598-616-11)

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": "4b43c865-fcdb-4e57-30a4-871e37e0e593", "openfda": {"nui": ["N0000193963", "N0000175788"], "unii": ["7AXV542LZ4"], "spl_set_id": ["03ef6420-8190-a404-f7f6-def1864a77de"], "pharm_class_epc": ["Pharmacologic Cardiac Stress Test Agent [EPC]"], "pharm_class_moa": ["Adenosine Receptor Agonists [MoA]"], "manufacturer_name": ["Dr. Reddy's Laboratories Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 mL in 1 CARTON (43598-616-11)", "package_ndc": "43598-616-11", "marketing_start_date": "20230423"}], "brand_name": "Regadenoson", "product_id": "43598-616_4b43c865-fcdb-4e57-30a4-871e37e0e593", "dosage_form": "INJECTION", "pharm_class": ["Adenosine Receptor Agonists [MoA]", "Pharmacologic Cardiac Stress Test Agent [EPC]"], "product_ndc": "43598-616", "generic_name": "Regadenoson", "labeler_name": "Dr. Reddy's Laboratories Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Regadenoson", "active_ingredients": [{"name": "REGADENOSON ANHYDROUS", "strength": ".08 mg/mL"}], "application_number": "ANDA213210", "marketing_category": "ANDA", "marketing_start_date": "20230423", "listing_expiration_date": "20261231"}