NDC 68083-175-01 - Regadenoson

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 68083-175
Requested NDC: 68083-175-01
Package NDCs from labels: 68083-175-01, 68083-175-10
Manufacturer: Gland Pharma Limited
Effective date: 2022-07-15
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Regadenoson - Gland Pharma Limited	Gland Pharma Limited	2022-07-15	Human Prescription Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68083-175-01	Regadenoson	5 mL in 1 VIAL	INJECTION, SOLUTION	5		5
68083-175-10	Regadenoson	10 in 1 CARTON	INJECTION, SOLUTION	10		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68083-175	REGADENOSON INJECTION, SOLUTION [GLAND PHARMA LIMITED]	5	Current NDC, Legacy NDC, 2 package rows	20220717_5e4109f0-4875-4f8e-b70d-4055b3a785a3.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 14 of 15 · 299 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Eye wash	PURIFIED WATER	McKesson	bd089fde-24ba-4de5-e053-2995a90a39bb	2022-10-18	Warnings	Exact identifier unii: 059QF0KO0R
Bach Original Flower Remedies Rock Water	WATER	Nelson Bach USA Limited	ea242559-1618-3354-e053-2a95a90a1a95	2022-10-03	Warnings	Exact identifier unii: 059QF0KO0R
Sterile Water	WATER	Medical Purchasing Solutions, LLC	e90b47e3-9636-b9ee-e053-2a95a90ad48c	2022-09-19	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Regadenoson	REGADENOSON	Gland Pharma Limited	5e4109f0-4875-4f8e-b70d-4055b3a785a3	2022-07-15	Warnings, Adverse reactions	Exact identifier application number: ANDA207320 ndc (package): 68083-175-01 ndc (package): 68083-175-10 ndc (product): 68083-175 ndc11 (package): 68083017501 spl id: 549593f6-8cfc-4182-8f3c-a60870187d8f spl set id: 5e4109f0-4875-4f8e-b70d-4055b3a785a3 unii: 2XLN4Y044H
Sterile Water	WATER	Fresenius Kabi USA, LLC	f42ac50f-0ec5-4713-a4c8-99d972d90bed	2022-06-22	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Sterile Water	WATER	Fresenius Kabi USA, LLC	e71c6c83-d518-496c-b2ab-efd5987e4783	2022-06-09	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Regadenoson	REGADENOSON	Meitheal Pharmaceuticals Inc.	a550b451-fb30-4c1c-a60e-6e40fba20c88	2022-04-15	Warnings, Adverse reactions	Exact identifier unii: 2XLN4Y044H
Sodium Phosphates	SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE AND SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	Fresenius Kabi USA, LLC	5bf47be3-f3fe-452b-8113-941796498345	2022-03-31	Warnings, Adverse reactions	Exact identifier unii: 593YOG76RN
Miracle FootCream Lavender	UREA, GLYCERIN, ALOE, DISODIUM EDTA	Aloe Vera Korea Co.,Ltd.	db520c80-2a2a-5eb1-e053-2995a90a5bb4	2022-03-28	Warnings	Exact identifier unii: 7FLD91C86K
Miracle FootCream Lemon	UREA, GLYCERIN, ALOE, DISODIUM EDTA	Aloe Vera Korea Co.,Ltd.	db525c63-29fd-2033-e053-2995a90a56b9	2022-03-28	Warnings	Exact identifier unii: 7FLD91C86K
Sterile Water	WATER	American Regent, Inc.	78b35864-4bbc-4759-a5c1-7e4f25e22932	2022-01-31	Boxed warning	Exact identifier unii: 059QF0KO0R
Sterile Diluent for Treprostinil	WATER	Dr.Reddy's Laboratories Inc.,	33050ee2-519b-1f0b-d4df-9e14dd329c57	2021-12-23	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
CPDA-1	ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE	Fenwal, Inc.	d763511e-f1a7-4014-94b9-f7ad8f023ff4	2021-12-02		Exact identifier unii: 593YOG76RN
CPDA-1	ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE	Fenwal, Inc.	cf9f43a0-c750-4cf0-ac49-176ab2105aab	2021-12-02		Exact identifier unii: 593YOG76RN
InterSol	PLATELET ADDITIVE 3	Fenwal, Inc.	e4f06c0b-7cb1-49c9-97a4-2cfc21298495	2021-11-16	Warnings, Adverse reactions	Exact identifier unii: 593YOG76RN
Solucion InterSol	SOLUCION ADITIVA PARA PLAQUETAS 3	Fenwal, Inc.	d5eaf5f4-67d3-4475-af9a-f5b0f882f5d1	2021-10-04	Warnings, Adverse reactions	Exact identifier unii: 593YOG76RN
Sterile Water	STERILE WATER	B. Braun Medical Inc.	d99f9133-e4d0-4dee-b611-dbc3f918b547	2021-08-09	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Sterile Water	WATER	B. Braun Medical Inc.	8924e52e-8622-4ed6-a061-1908183e0a18	2021-08-06	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Sodium Phosphates	SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	Fresenius Kabi USA, LLC	e6169d3b-39d2-47f9-8d5b-b53ec069a722	2021-07-23	Warnings, Adverse reactions	Exact identifier unii: 593YOG76RN
Eyewash	EYEWASH	Global Equipment Company	c4f78121-4668-2e0c-e053-2995a90ab6c6	2021-06-17	Warnings	Exact identifier unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.