adenosine

Product NDC: 67457-855
Requested package NDC: 67457-855-02
11-digit product format: 674570855
Labeler code: 67457
Product ID: 67457-855_a807e222-e981-48ee-8d2c-b226b90347bb
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: adenosine
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: Mylan Institutional LLC
Application: ANDA078686
Marketing category: ANDA
Marketing start: 2018-05-08
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 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
A078686-001	ADENOSINE	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP		2009-05-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078686-001	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 · 41 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
2026-02-19 14:30 UTC	2026-02	A078686-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2009-05-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078686-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2009-05-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078686-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2009-05-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078686-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2009-05-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078686-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2009-05-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078686-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2009-05-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078686-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2009-05-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078686-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2009-05-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078686-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2009-05-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078686-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2009-05-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078686-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2009-05-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078686-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2009-05-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078686-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2009-05-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078686-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2009-05-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078686-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2009-05-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078686-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2009-05-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078686-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2009-05-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078686-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2009-05-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078686-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2009-05-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078686-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2009-05-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078686-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2009-05-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078686-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2009-05-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078686-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2009-05-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078686-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2009-05-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078686-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2009-05-13	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078686-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2009-05-13	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078686-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2009-05-13	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078686-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2009-05-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078686-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2009-05-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078686-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2009-05-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078686-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2009-05-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078686-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2009-05-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078686-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2009-05-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078686-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2009-05-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078686-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2009-05-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078686-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2009-05-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078686-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2009-05-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078686-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2009-05-13	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078686-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2009-05-13	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078686-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2009-05-13	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078686-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078686-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078686-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078686-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078686-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078686-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078686-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078686-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078686-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078686-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078686-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078686-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078686-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078686-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078686-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078686-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078686-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078686-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078686-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078686-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078686-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078686-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078686-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078686-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078686-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078686-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078686-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078686-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078686-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078686-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078686-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078686-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078686-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078686-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078686-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078686-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078686-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078686-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078686-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078686-001	AP	1	`cb3db0bc1861…`

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1654169	Internal RxNorm lookup
1654186	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
d2d06ee6-c89f-49f7-9e2c-46d33ce877a9	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
67457-855-00	adenosine	2 mL in 1 VIAL, SINGLE-DOSE	INJECTION	2		3
67457-855-02	adenosine	10 in 1 CARTON	INJECTION	10		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
67457-855-00	ML - Milliliter	67457-855	03f908b7-3a70-4263-ad11-dba46237d585	1	2019-08-06
67457-855-02	ML - Milliliter	67457-855	bd1b0f07-41b7-4b3e-9794-fbd168680f15	1	2018-06-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67457-855	ADENOSINE INJECTION [MYLAN INSTITUTIONAL LLC]	3	Current NDC, Legacy NDC, 2 package rows	20240601_d2d06ee6-c89f-49f7-9e2c-46d33ce877a9.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
adenosine	ADENOSINE	Medical Purchasing Solutions, LLC	a2a2fef9-d305-40ba-e053-2a95a90a0c54	2023-05-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078686 application number: ANDA078686
ADENOSINE	ADENOSINE	HF Acquisition Co LLC, DBA HealthFirst	fa6eb0f8-7c41-2e17-e053-6294a90ac8ca	2023-04-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078686 application number: ANDA078686
adenosine	ADENOSINE	Mylan Institutional LLC	c1c149fe-9095-4b2a-a21f-7af3212e0254	2022-04-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078686 application number: ANDA078686
adenosine	ADENOSINE	Mylan Institutional LLC	d2d06ee6-c89f-49f7-9e2c-46d33ce877a9	2021-06-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078686 application number: ANDA078686 ndc (package): 67457-855-02 ndc (product): 67457-855 ndc11 (package): 67457085502

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
1654186	adenosine 12 MG in 4 mL Injection	PSN	d2d06ee6-c89f-49f7-9e2c-46d33ce877a9	3
1654169	adenosine 6 MG in 2 ML Injection	PSN	d2d06ee6-c89f-49f7-9e2c-46d33ce877a9	3
1654169	2 ML adenosine 3 MG/ML Injection	SCD	d2d06ee6-c89f-49f7-9e2c-46d33ce877a9	3
1654186	4 ML adenosine 3 MG/ML Injection	SCD	d2d06ee6-c89f-49f7-9e2c-46d33ce877a9	3
1654186	adenosine 12 MG per 4 ML Injection	SY	d2d06ee6-c89f-49f7-9e2c-46d33ce877a9	3
1654169	adenosine 6 MG per 2 ML Injection	SY	d2d06ee6-c89f-49f7-9e2c-46d33ce877a9	3
1654169	adenosine 6 MG in 2 ML Injection	PSN	a2a2fef9-d305-40ba-e053-2a95a90a0c54	2
1654169	2 ML adenosine 3 MG/ML Injection	SCD	a2a2fef9-d305-40ba-e053-2a95a90a0c54	2
1654169	adenosine 6 MG per 2 ML Injection	SY	a2a2fef9-d305-40ba-e053-2a95a90a0c54	2
1654169	adenosine 6 MG in 2 ML Injection	PSN	fa6eb0f8-7c41-2e17-e053-6294a90ac8ca	1
1654169	2 ML adenosine 3 MG/ML Injection	SCD	fa6eb0f8-7c41-2e17-e053-6294a90ac8ca	1
1654169	adenosine 6 MG per 2 ML Injection	SY	fa6eb0f8-7c41-2e17-e053-6294a90ac8ca	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
67457-855-02	67457085502	10 VIAL, SINGLE-DOSE in 1 CARTON (67457-855-02) / 2 mL in 1 VIAL, SINGLE-DOSE (67457-855-00)	2018-05-08	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Adenosine Injection, USP	Medical Purchasing Solutions, LLC	2023-05-03	HUMAN PRESCRIPTION DRUG LABEL	2
ADENOSINE INJECTION, USP 6mg/2mL (3mg/mL) 2mL VIAL	HF Acquisition Co LLC, DBA HealthFirst	2023-04-28	HUMAN PRESCRIPTION DRUG LABEL	1
Adenosine Injection, USP	Mylan Institutional LLC	2021-06-16	HUMAN PRESCRIPTION DRUG LABEL	3
Adenosine Injection, USP	REMEDYREPACK INC.	2021-02-09	HUMAN PRESCRIPTION DRUG LABEL	1