Regadenoson

Product NDC: 83032-001
Requested package NDC: 83032-001-02
11-digit product format: 830320001
Labeler code: 83032
Product ID: 83032-001_46d9a23a-0b83-5f6f-e063-6394a90a8e79
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Regadenoson
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Indies Pharma Jamaica Limited
Application: ANDA218054
Marketing category: ANDA
Marketing start: 2024-08-22
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A218054-001	REGADENOSON	REGADENOSON	0.4MG/5ML (0.08MG/ML)	SOLUTION / INTRAVENOUS	AP		2024-08-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A218054-001	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
2026-09-14 22:38:34	2026-08	A218054-001	REGADENOSON	0.4MG/5ML (0.08MG/ML)	SOLUTION / INTRAVENOUS	AP	2024-08-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A218054-001	REGADENOSON	0.4MG/5ML (0.08MG/ML)	SOLUTION / INTRAVENOUS	AP	2024-08-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A218054-001	REGADENOSON	0.4MG/5ML (0.08MG/ML)	SOLUTION / INTRAVENOUS	AP	2024-08-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218054-001	REGADENOSON	0.4MG/5ML (0.08MG/ML)	SOLUTION / INTRAVENOUS	AP	2024-08-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A218054-001	REGADENOSON	0.4MG/5ML (0.08MG/ML)	SOLUTION / INTRAVENOUS	AP	2024-08-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218054-001	REGADENOSON	0.4MG/5ML (0.08MG/ML)	SOLUTION / INTRAVENOUS	AP	2024-08-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218054-001	REGADENOSON	0.4MG/5ML (0.08MG/ML)	SOLUTION / INTRAVENOUS	AP	2024-08-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218054-001	REGADENOSON	0.4MG/5ML (0.08MG/ML)	SOLUTION / INTRAVENOUS	AP	2024-08-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218054-001	REGADENOSON	0.4MG/5ML (0.08MG/ML)	SOLUTION / INTRAVENOUS	AP	2024-08-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A218054-001	REGADENOSON	0.4MG/5ML (0.08MG/ML)	SOLUTION / INTRAVENOUS	AP	2024-08-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A218054-001	REGADENOSON	0.4MG/5ML (0.08MG/ML)	SOLUTION / INTRAVENOUS	AP	2024-08-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A218054-001	REGADENOSON	0.4MG/5ML (0.08MG/ML)	SOLUTION / INTRAVENOUS	AP	2024-08-22	`d06236e962d9…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218054-001	REGADENOSON	0.4MG/5ML (0.08MG/ML)	SOLUTION / INTRAVENOUS	AP	2024-08-22	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A218054-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A218054-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A218054-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218054-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A218054-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218054-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218054-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218054-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218054-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A218054-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A218054-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A218054-001	AP	1	`d06236e962d9…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218054-001	AP	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Regadenoson
Listing expiration: 2026-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2XLN4Y044H	Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
5095ab40-8503-46db-9b08-6a36f05fb5d9	Available on FDA.report

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
83032-001-02	Regadenoson	5 mL in 1 SYRINGE	INJECTION, SOLUTION	5		2
83032-001-02	Regadenoson	1 in 1 CARTON	INJECTION, SOLUTION	1		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
83032-001	REGADENOSON INJECTION, SOLUTION [INDIES PHARMA JAMAICA LIMITED]	1	Current NDC, 2 package rows	20240904_5095ab40-8503-46db-9b08-6a36f05fb5d9.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Regadenoson	REGADENOSON	Indies Pharma Jamaica Limited	5095ab40-8503-46db-9b08-6a36f05fb5d9	2025-12-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218054 application number: ANDA218054 ndc (package): 83032-001-02 ndc (product): 83032-001 ndc11 (package): 83032000102
Regadenoson	REGADENOSON	Kanchan Healthcare Inc	b183399d-b8dc-4924-90cd-a1c2247742f3	2025-08-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218054 application number: ANDA218054
Regadenoson	REGADENOSON	Marlex Pharmaceuticals, Inc.	843bfba9-47de-4d76-843a-997bb4564f6e	2025-02-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218054 application number: ANDA218054

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
83032-001-02	83032000102	1 SYRINGE in 1 CARTON (83032-001-02) / 5 mL in 1 SYRINGE	1 syringe	2024-08-22	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Regadenoson	Indies Pharma Jamaica Limited \| ABRYL LABORATORIES PRIVATE LIMITED	2025-12-26	HUMAN PRESCRIPTION DRUG LABEL	2