Application 076573

Type: ANDA
Sponsor: FRESENIUS KABI USA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ESMOLOL HYDROCHLORIDE	ESMOLOL HYDROCHLORIDE	INJECTABLE;INJECTION	10MG/ML	No	No
002	ESMOLOL HYDROCHLORIDE	ESMOLOL HYDROCHLORIDE	INJECTABLE;INJECTION	20MG/ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A076573-001	ESMOLOL HYDROCHLORIDE	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION			2005-05-02
A076573-002	ESMOLOL HYDROCHLORIDE	ESMOLOL HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION			2023-08-23

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 · 63 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	A076573-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION		2005-05-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076573-002	ESMOLOL HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION		2023-08-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076573-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION		2005-05-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076573-002	ESMOLOL HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION		2023-08-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076573-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION		2005-05-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076573-002	ESMOLOL HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION		2023-08-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076573-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION		2005-05-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076573-002	ESMOLOL HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION		2023-08-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076573-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION		2005-05-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076573-002	ESMOLOL HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION		2023-08-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076573-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION		2005-05-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076573-002	ESMOLOL HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION		2023-08-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076573-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION		2005-05-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076573-002	ESMOLOL HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION		2023-08-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076573-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION		2005-05-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076573-002	ESMOLOL HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION		2023-08-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076573-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION		2005-05-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076573-002	ESMOLOL HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION		2023-08-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076573-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION		2005-05-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076573-002	ESMOLOL HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION		2023-08-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076573-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION		2005-05-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076573-002	ESMOLOL HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION		2023-08-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076573-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION		2005-05-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076573-002	ESMOLOL HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION		2023-08-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076573-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION		2005-05-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076573-002	ESMOLOL HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION		2023-08-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076573-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION		2005-05-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076573-002	ESMOLOL HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION		2023-08-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076573-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION		2005-05-02	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076573-002	ESMOLOL HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION		2023-08-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076573-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2005-05-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076573-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2005-05-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076573-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2005-05-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076573-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2005-05-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076573-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2005-05-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076573-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2005-05-02	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076573-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2005-05-02	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076573-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2005-05-02	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076573-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2005-05-02	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076573-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2005-05-02	`c0c555d07b60…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076573-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076573-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076573-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076573-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076573-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076573-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076573-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076573-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076573-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076573-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076573-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076573-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076573-001	AP	1	`ea99ee380514…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076573-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076573-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076573-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076573-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076573-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076573-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076573-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076573-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076573-001	AP	1	`cb3db0bc1861…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Esmolol Hydrochloride	ESMOLOL HYDROCHLORIDE	Fresenius Kabi USA, LLC	fdc9cea8-0eb4-4930-9e1c-d44bfa9346d2	2024-11-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076573 application number: ANDA076573 ndc (product): 63323-652
ESMOLOL HYDROCHLORIDE	ESMOLOL HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	993df35b-0006-4892-e053-2a95a90a0dba	2022-12-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076573 application number: ANDA076573 ndc (product): 51662-1371

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
51662-1371	ESMOLOL HYDROCHLORIDE	ESMOLOL HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
51662-1371	ESMOLOL HYDROCHLORIDE	ESMOLOL HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
51662-1371	ESMOLOL HYDROCHLORIDE	ESMOLOL HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
63323-652	Esmolol Hydrochloride	ESMOLOL HYDROCHLORIDE	Fresenius Kabi USA, LLC	ANDA	Current
63323-652	Esmolol Hydrochloride	ESMOLOL HYDROCHLORIDE	Fresenius Kabi USA, LLC	ANDA	Current