Adenosine

Product NDC: 84549-318
11-digit product format: 845490318
Labeler code: 84549
Product ID: 84549-318_462a9434-31da-b18f-e063-6294a90a2f75
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Adenosine
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: ProPharma Distribution
Application: ANDA206778
Marketing category: ANDA
Marketing start: 2023-03-15
Substance: ADENOSINE
Active strength: 3 mg/mL
Pharmacologic classes: Adenosine Receptor Agonist [EPC], Adenosine Receptor Agonists [MoA]
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 42.

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
A206778-001	ADENOSINE	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP		2018-02-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206778-001	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.

Product history page 1 of 2 · 42 observed 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
2026-08-18 06:07:40	2026-07	A206778-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2018-02-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206778-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2018-02-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206778-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2018-02-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206778-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2018-02-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206778-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2018-02-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206778-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2018-02-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206778-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2018-02-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206778-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2018-02-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206778-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2018-02-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206778-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2018-02-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206778-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2018-02-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206778-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2018-02-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206778-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2018-02-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206778-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2018-02-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206778-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2018-02-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206778-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2018-02-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206778-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2018-02-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206778-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2018-02-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206778-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2018-02-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206778-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2018-02-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206778-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2018-02-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206778-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2018-02-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206778-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2018-02-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206778-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2018-02-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206778-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2018-02-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206778-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2018-02-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206778-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2018-02-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206778-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2018-02-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206778-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2018-02-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206778-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2018-02-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206778-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2018-02-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206778-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2018-02-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206778-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2018-02-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206778-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2018-02-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206778-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2018-02-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206778-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2018-02-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206778-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2018-02-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206778-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2018-02-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206778-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2018-02-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206778-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2018-02-16	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A206778-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206778-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206778-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206778-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206778-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206778-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206778-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206778-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206778-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206778-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206778-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206778-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206778-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206778-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206778-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206778-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206778-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206778-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206778-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206778-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206778-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206778-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206778-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206778-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206778-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206778-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206778-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206778-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206778-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206778-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206778-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206778-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206778-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206778-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206778-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206778-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206778-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206778-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206778-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206778-001	AP	1	`e64feba35796…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ADENOSINE	3 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
K72T3FS567	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1654169	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
364a4c53-0705-7969-e063-6294a90a1717	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d676a241-be05-4740-b3ee-1a5f2ed422d2	Product name	4	20180615
dd8bd48f-20d6-43c7-b471-3ae872868afa	Product name	3	20180125
d41954ff-bc63-4b2c-aba0-9146707659d7	Product name	2	20151117

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
84549-318-02	Adenosine	2 mL in 1 VIAL	INJECTION	2		3

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Adenosine	ADENOSINE	Sagent Pharmaceuticals	546642f2-662f-46cf-9d82-5bb3bdcc7677	2026-07-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206778 application number: ANDA206778
Adenosine	ADENOSINE	ProPharma Distribution	364a4c53-0705-7969-e063-6294a90a1717	2025-12-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206778 application number: ANDA206778 ndc (product): 84549-318
Adenosine	ADENOSINE	REMEDYREPACK INC.	9508caf5-0e3a-4d32-909d-bff7ea40ec30	2025-09-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206778 application number: ANDA206778
Adenosine	ADENOSINE	Medical Purchasing Solutions, LLC	296af833-5724-3e23-e063-6394a90a6251	2024-12-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206778 application number: ANDA206778
Adenosine	ADENOSINE	Gland Pharma Limited	1b701a86-3c4e-4c13-bf9e-aa9e73774c20	2018-02-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206778 application number: ANDA206778

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
K72T3FS567	ADENOSINE	58-61-7	ADENOSINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1654169	adenosine 6 MG in 2 ML Injection	PSN	364a4c53-0705-7969-e063-6294a90a1717	3
1654169	2 ML adenosine 3 MG/ML Injection	SCD	364a4c53-0705-7969-e063-6294a90a1717	3
1654169	adenosine 6 MG per 2 ML Injection	SY	364a4c53-0705-7969-e063-6294a90a1717	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
84549-318-02	84549031802	2 mL in 1 VIAL (84549-318-02)	2 ml	2025-08-27	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ADENOSINE INJECTION, USP FOR RAPID BOLUS INTRAVENOUS USE	ProPharma Distribution	2025-12-17	HUMAN PRESCRIPTION DRUG LABEL	3