Esmolol Hydrochloride

Product NDC: 50090-4699
Requested package NDC: 50090-4699-0
11-digit product format: 500904699
Labeler code: 50090
Product ID: 50090-4699_f6b1e063-42c8-4a90-a7b6-bae6e29b2046
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: esmolol hydrochloride
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: A-S Medication Solutions
Application: ANDA076474
Marketing category: ANDA
Marketing start: 2007-05-29
Marketing end: 0000-00-00
Substance: ESMOLOL HYDROCHLORIDE
Active strength: 10 mg/mL
Pharmacologic classes: Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	50090-4699	50090-4699-0	I	Inactivated by FDA		2026-09-14

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

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
A076474-001	ESMOLOL HYDROCHLORIDE	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP		2005-05-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076474-001	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 · 43 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
2026-09-14 22:38:34	2026-08	A076474-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2005-05-02	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076474-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2005-05-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076474-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2005-05-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076474-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2005-05-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076474-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2005-05-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076474-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2005-05-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076474-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2005-05-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076474-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2005-05-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076474-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2005-05-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076474-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2005-05-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076474-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2005-05-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076474-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2005-05-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076474-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2005-05-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076474-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2005-05-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076474-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2005-05-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076474-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2005-05-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076474-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2005-05-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076474-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2005-05-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076474-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2005-05-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076474-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2005-05-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076474-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2005-05-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076474-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2005-05-02	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076474-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2005-05-02	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076474-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2005-05-02	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076474-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2005-05-02	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076474-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2005-05-02	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076474-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2005-05-02	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076474-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2005-05-02	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076474-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2005-05-02	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076474-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2005-05-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076474-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2005-05-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076474-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2005-05-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076474-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2005-05-02	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076474-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2005-05-02	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076474-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2005-05-02	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076474-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2005-05-02	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076474-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2005-05-02	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076474-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2005-05-02	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076474-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2005-05-02	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076474-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2005-05-02	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A076474-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076474-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076474-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076474-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076474-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076474-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076474-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076474-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076474-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076474-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076474-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076474-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076474-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076474-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076474-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076474-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076474-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076474-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076474-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076474-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076474-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076474-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076474-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076474-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076474-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076474-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076474-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076474-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076474-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076474-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076474-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076474-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076474-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076474-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076474-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076474-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076474-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076474-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076474-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076474-001	AP	1	`f41ea6bd6efb…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a21a21e5-f36d-4c1f-8918-def921b8f7e3	Product name	3	20250124
ab3d10ea-fe48-4811-8e72-bb51600b35f9	Product name	5	20230103
9cb9173b-3912-466b-8256-366e71d49fce	Product name	1	20190402
48747306-602a-42cc-957b-5b0c69158eee	Product name	1	20180604
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578b	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50090-4699-0	2023-01-30	C162847	48780-1	f386c649-e037-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use ESMOLOL HYDROCHLORIDE INJECTION safely and effectively. See full prescribing information for ESMOLOL HYDROCHLORIDE INJECTION . ESMOLOL HYDROCHLORIDE injection, for intravenous use Initial U.S. Approval: 1986

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-4699-0	Esmolol Hydrochloride	10 mL in 1 VIAL	INJECTION, SOLUTION	10		1
50090-4699-0	Esmolol Hydrochloride	10 in 1 CARTON	INJECTION, SOLUTION	10		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-4699	ESMOLOL HYDROCHLORIDE INJECTION, SOLUTION [A-S MEDICATION SOLUTIONS]	1	Legacy NDC, 2 package rows	20191206_55def2c7-b354-47e6-bd25-6ecd92860795.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
Esmolol Hydrochloride	ESMOLOL HYDROCHLORIDE	Henry Schein, Inc.	9c1e3a64-0ef0-4071-ad6f-63ff8789b198	2025-06-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076474 application number: ANDA076474
Esmolol Hydrochloride	ESMOLOL HYDROCHLORIDE	Mylan Institutional LLC	94f069f9-dd52-4a69-a103-ebdb4294f088	2025-02-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076474 application number: ANDA076474
ESMOLOL HYDROCHLORIDE	ESMOLOL HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	789730fa-eaca-4986-e053-2a91aa0a5339	2024-02-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076474 application number: ANDA076474

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
V05260LC8D	ESMOLOL HYDROCHLORIDE	81161-17-3	ESMOLOL HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1736546	esmolol HCl 100 MG in 10 ML Injection	PSN	55def2c7-b354-47e6-bd25-6ecd92860795	1
1736546	10 ML esmolol hydrochloride 10 MG/ML Injection	SCD	55def2c7-b354-47e6-bd25-6ecd92860795	1
1736546	esmolol HCl 100 MG per 10 ML Injection	SY	55def2c7-b354-47e6-bd25-6ecd92860795	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-4699-0	50090469900	10 VIAL in 1 CARTON (50090-4699-0) > 10 mL in 1 VIAL	10 vial	2019-11-08	0000-00-00	No	No	Current