Esmolol Hydrochloride

Product NDC: 84549-194
11-digit product format: 845490194
Labeler code: 84549
Product ID: 84549-194_463cc756-d1d0-9ffe-e063-6394a90ab342
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Esmolol Hydrochloride
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: ProPharma Distribution
Application: ANDA205520
Marketing category: ANDA
Marketing start: 2015-07-23
Substance: ESMOLOL HYDROCHLORIDE
Active strength: 100 mg/10mL
Pharmacologic classes: Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
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
A205520-001	ESMOLOL HYDROCHLORIDE	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP		2015-07-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205520-001	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	A205520-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2015-07-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205520-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2015-07-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205520-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2015-07-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205520-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2015-07-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205520-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2015-07-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205520-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2015-07-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205520-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2015-07-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205520-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2015-07-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205520-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2015-07-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205520-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2015-07-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205520-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2015-07-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205520-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2015-07-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205520-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2015-07-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205520-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2015-07-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205520-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2015-07-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205520-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2015-07-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205520-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2015-07-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205520-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2015-07-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205520-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2015-07-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205520-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2015-07-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205520-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2015-07-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205520-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2015-07-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205520-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2015-07-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205520-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2015-07-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205520-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2015-07-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205520-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2015-07-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205520-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2015-07-23	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205520-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2015-07-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205520-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2015-07-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A205520-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2015-07-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205520-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2015-07-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205520-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2015-07-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205520-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2015-07-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205520-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2015-07-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A205520-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2015-07-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205520-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2015-07-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205520-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2015-07-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A205520-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2015-07-23	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A205520-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2015-07-23	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A205520-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2015-07-23	`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	A205520-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205520-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205520-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205520-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205520-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205520-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205520-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205520-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205520-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205520-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205520-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205520-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205520-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205520-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205520-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205520-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205520-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205520-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205520-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205520-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205520-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205520-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205520-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205520-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205520-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205520-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205520-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205520-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205520-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A205520-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205520-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205520-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205520-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205520-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A205520-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205520-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205520-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A205520-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A205520-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A205520-001	AP	1	`cb3db0bc1861…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ESMOLOL HYDROCHLORIDE	100 mg/10mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
V05260LC8D	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1736546	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
3853a26d-782d-f4e7-e063-6294a90a6e47	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
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
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578b	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
84549-194-10	Esmolol Hydrochloride	10 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION	10		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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Esmolol Hydrochloride	ESMOLOL HYDROCHLORIDE	ProPharma Distribution	3853a26d-782d-f4e7-e063-6294a90a6e47	2025-12-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205520 application number: ANDA205520 ndc (product): 84549-194
Esmolol Hydrochloride	ESMOLOL HYDROCHLORIDE	REMEDYREPACK INC.	1f5707f2-a8a7-4a5f-b846-64585b5e3f9f	2025-07-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205520 application number: ANDA205520
ESMOLOL HYDROCHLORIDE	ESMOLOL HYDROCHLORIDE	Henry Schein, Inc.	519cc19c-e2b6-4984-bfad-45276d4cf0e6	2025-01-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205520 application number: ANDA205520
Esmolol Hydrochloride	ESMOLOL HYDROCHLORIDE	Eugia US LLC	ac22475d-2d78-469f-9435-b403ac4ee380	2024-09-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205520 application number: ANDA205520
ESMOLOL HYDROCHLORIDE	ESMOLOL HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	9a52d2fd-e551-f8f1-e053-2995a90a6c09	2024-01-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205520 application number: ANDA205520
Esmolol Hydrochloride	ESMOLOL HYDROCHLORIDE	Medical Purchasing Solutions, LLC	6bb9921c-a0f9-309f-e053-2a91aa0a1e5e	2023-05-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205520 application number: ANDA205520

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	3853a26d-782d-f4e7-e063-6294a90a6e47	3
1736546	10 ML esmolol hydrochloride 10 MG/ML Injection	SCD	3853a26d-782d-f4e7-e063-6294a90a6e47	3
1736546	esmolol HCl 100 MG per 10 ML Injection	SY	3853a26d-782d-f4e7-e063-6294a90a6e47	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
84549-194-10	84549019410	10 mL in 1 VIAL, SINGLE-DOSE (84549-194-10)	10 ml	2025-08-27	No	No	Current