Regadenoson

Product NDC: 0409-1401
11-digit product format: 004091401
Labeler code: 0409
Product ID: 0409-1401_67995dbc-0e79-4b3b-a6f8-eaeb5048ff3d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Regadenoson
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Hospira, Inc.
Application: ANDA214349
Marketing category: ANDA
Marketing start: 2023-03-01
Substance: REGADENOSON ANHYDROUS
Active strength: .08 mg/mL
Pharmacologic classes: Adenosine Receptor Agonists [MoA], Pharmacologic Cardiac Stress Test Agent [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Additional Listing Data#

Ingredient, Strength table
Ingredient	Strength
REGADENOSON ANHYDROUS	.08 mg/mL

Field, Values table
Field	Values
Unii	7AXV542LZ4

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
60758f30-9b07-ad4c-2eb4-c357ebb784a4	Product name	5	20250317
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
19c71a3d-ed9c-166b-a7e5-38c250c35631	Product name	1	20140508

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0409-1401-01	2025-09-02	C162847	48780-1	3b156c62-2618-fb37-e063-e6dba90a4e07	These highlights do not include all the information needed to use REGADENOSON INJECTION safely and effectively. See full prescribing information for REGADENOSON INJECTION. REGADENOSON injection, for intravenous use Initial U.S. Approval: 2008
0409-1401-01	2025-07-29	C162847	48780-1	3b156c62-2618-fb37-e063-e6dba90a4e07	These highlights do not include all the information needed to use REGADENOSON INJECTION safely and effectively. See full prescribing information for REGADENOSON INJECTION. REGADENOSON injection, for intravenous use Initial U.S. Approval: 2008

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0409-1401-01	Regadenoson	10 in 1 PACKAGE	INJECTION, SOLUTION	10	4
0409-1401-01	Regadenoson	1 in 1 CARTON	INJECTION, SOLUTION	1	4
0409-1401-05	Regadenoson	5 mL in 1 SYRINGE, PLASTIC	INJECTION, SOLUTION	5	4

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0409-1401	REGADENOSON INJECTION, SOLUTION [HOSPIRA, INC.]	3	Current NDC, 3 package rows	20240731_0e3f080d-b1fb-47ed-8cd3-90a4206fa704.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
7AXV542LZ4	REGADENOSON ANHYDROUS	313348-27-5	REGADENOSON ANHYDROUS
2XLN4Y044H	REGADENOSON	875148-45-1	Regadenoson

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
0409-1401-01	00409140101	10 CARTON in 1 PACKAGE (0409-1401-01) / 1 SYRINGE, PLASTIC in 1 CARTON / 5 mL in 1 SYRINGE, PLASTIC (0409-1401-05)	10 carton	2023-03-01	No	No	Current
0409-1401-05	00409140105	5 mL in 1 SYRINGE, PLASTIC	5 ml				Historical