Adenosine

Product NDC: 68083-157
11-digit product format: 680830157
Labeler code: 68083
Product ID: 68083-157_acdf6567-6d2d-4adc-9ba2-c4528fe02a05
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Adenosine
Dosage form: SOLUTION
Route: INTRAVENOUS
Labeler: Gland Pharma Limited
Application: ANDA206778
Marketing category: ANDA
Marketing start: 2017-01-13
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
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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
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…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A206778-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2018-02-16	`cb3db0bc1861…`
2026-08-01 22:54:32	2026-06	A206778-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	AP	2018-02-16	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A206778-001	AP	1	`cb3db0bc1861…`
2026-08-01 22:54:32	2026-06	A206778-001	AP	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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	ProPharma Distribution	364a4c53-0705-7969-e063-6294a90a1717	2025-12-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206778 application number: ANDA206778
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	Sagent Pharmaceuticals	546642f2-662f-46cf-9d82-5bb3bdcc7677	2023-02-23	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 ndc (product): 68083-157

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
1b701a86-3c4e-4c13-bf9e-aa9e73774c20	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
68083-157-10	Adenosine	4 mL in 1 VIAL	SOLUTION	4		3
68083-157-10	Adenosine	10 in 1 CARTON	SOLUTION	10		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68083-157	ADENOSINE SOLUTION [GLAND PHARMA LIMITED]	3	Current NDC, Legacy NDC, 2 package rows	20180221_1b701a86-3c4e-4c13-bf9e-aa9e73774c20.zip

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	1b701a86-3c4e-4c13-bf9e-aa9e73774c20	3
1654169	adenosine 6 MG in 2 ML Injection	PSN	1b701a86-3c4e-4c13-bf9e-aa9e73774c20	3
1654169	2 ML adenosine 3 MG/ML Injection	SCD	1b701a86-3c4e-4c13-bf9e-aa9e73774c20	3
1654186	4 ML adenosine 3 MG/ML Injection	SCD	1b701a86-3c4e-4c13-bf9e-aa9e73774c20	3
1654186	adenosine 12 MG per 4 ML Injection	SY	1b701a86-3c4e-4c13-bf9e-aa9e73774c20	3
1654169	adenosine 6 MG per 2 ML Injection	SY	1b701a86-3c4e-4c13-bf9e-aa9e73774c20	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68083-157-10	68083015710	10 VIAL in 1 CARTON (68083-157-10) / 4 mL in 1 VIAL	10 vial	2017-01-13	0000-00-00	No	No	Current