Regadenoson

Product NDC: 72611-874
11-digit product format: 726110874
Labeler code: 72611
Product ID: 72611-874_442e8404-64f2-db43-c8d9-0f4986ac49fa
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Regadenoson
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Almaject, Inc.
Application: ANDA207320
Marketing category: ANDA
Marketing start: 2023-07-03
Substance: REGADENOSON
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	72611-874		D	Discontinued by firm		2026-08-07
excluded package	package	72611-874	72611-874-10	D	Discontinued by firm		2026-08-07

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A207320-001	REGADENOSON	REGADENOSON	0.4MG/5ML (0.08MG/ML)	SOLUTION / INTRAVENOUS	AP		2022-07-12

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A207320-001	AP

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A207320-001	REGADENOSON	0.4MG/5ML (0.08MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-07-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207320-001	REGADENOSON	0.4MG/5ML (0.08MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-07-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207320-001	REGADENOSON	0.4MG/5ML (0.08MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-07-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207320-001	REGADENOSON	0.4MG/5ML (0.08MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-07-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207320-001	REGADENOSON	0.4MG/5ML (0.08MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-07-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207320-001	REGADENOSON	0.4MG/5ML (0.08MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-07-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207320-001	REGADENOSON	0.4MG/5ML (0.08MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-07-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207320-001	REGADENOSON	0.4MG/5ML (0.08MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-07-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207320-001	REGADENOSON	0.4MG/5ML (0.08MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-07-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207320-001	REGADENOSON	0.4MG/5ML (0.08MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-07-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207320-001	REGADENOSON	0.4MG/5ML (0.08MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-07-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207320-001	REGADENOSON	0.4MG/5ML (0.08MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-07-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207320-001	REGADENOSON	0.4MG/5ML (0.08MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-07-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207320-001	REGADENOSON	0.4MG/5ML (0.08MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-07-12	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207320-001	REGADENOSON	0.4MG/5ML (0.08MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-07-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207320-001	REGADENOSON	0.4MG/5ML (0.08MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-07-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207320-001	REGADENOSON	0.4MG/5ML (0.08MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-07-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207320-001	REGADENOSON	0.4MG/5ML (0.08MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-07-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207320-001	REGADENOSON	0.4MG/5ML (0.08MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-07-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207320-001	REGADENOSON	0.4MG/5ML (0.08MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-07-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207320-001	REGADENOSON	0.4MG/5ML (0.08MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-07-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207320-001	REGADENOSON	0.4MG/5ML (0.08MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-07-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207320-001	REGADENOSON	0.4MG/5ML (0.08MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-07-12	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207320-001	REGADENOSON	0.4MG/5ML (0.08MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-07-12	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207320-001	REGADENOSON	0.4MG/5ML (0.08MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-07-12	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207320-001	REGADENOSON	0.4MG/5ML (0.08MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-07-12	`e64feba35796…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A207320-001	REGADENOSON	0.4MG/5ML (0.08MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-07-12	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A207320-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207320-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207320-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207320-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207320-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207320-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207320-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207320-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207320-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207320-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207320-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207320-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207320-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207320-001	AP	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207320-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207320-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207320-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207320-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207320-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207320-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207320-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207320-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207320-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207320-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207320-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207320-001	AP	1	`e64feba35796…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A207320-001	AP	1	`a50c72e98297…`

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72611-874-01	Regadenoson	5 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION	5		3
72611-874-10	Regadenoson	10 in 1 CARTON	INJECTION, SOLUTION	10		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72611-874-01	ML - Milliliter	72611-874	e08fb07b-71a3-40a1-9ae4-66c03a99aaea	1	2023-08-08
72611-874-10	ML - Milliliter	72611-874	33bcf72b-ced1-4f59-94f1-8c3d01404f3b	1	2023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72611-874	REGADENOSON INJECTION, SOLUTION [ALMAJECT, INC.]	2	Current NDC, 2 package rows	20241009_991f6634-2d5c-6ceb-4bee-22fd144a6ff7.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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Regadenoson	REGADENOSON	Gland Pharma Limited	5e4109f0-4875-4f8e-b70d-4055b3a785a3	2022-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207320 application number: ANDA207320

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
2XLN4Y044H	REGADENOSON	875148-45-1	REGADENOSON

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
72611-874-01	72611087401	5 mL in 1 VIAL, SINGLE-DOSE	5 ml				Historical
72611-874-10	72611087410	10 VIAL, SINGLE-DOSE in 1 CARTON (72611-874-10) / 5 mL in 1 VIAL, SINGLE-DOSE (72611-874-01)		2023-07-03	No	No	Historical