Esmolol Hydrochloride

Product NDC: 68083-211
Requested package NDC: 68083-211-25
11-digit product format: 680830211
Labeler code: 68083
Product ID: 68083-211_91f3287c-e1f4-48a0-a37e-74da91240a2d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Esmolol Hydrochloride
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: Gland Pharma Limited
Application: ANDA208538
Marketing category: ANDA
Marketing start: 2019-08-19
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: 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
A208538-001	ESMOLOL HYDROCHLORIDE	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP		2019-08-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208538-001	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
2026-02-19 14:30 UTC	2026-02	A208538-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2019-08-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208538-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2019-08-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208538-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2019-08-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208538-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2019-08-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208538-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2019-08-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208538-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2019-08-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208538-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2019-08-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208538-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2019-08-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208538-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2019-08-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208538-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2019-08-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208538-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2019-08-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208538-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2019-08-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208538-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2019-08-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208538-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2019-08-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208538-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2019-08-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208538-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2019-08-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208538-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2019-08-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208538-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2019-08-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208538-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2019-08-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208538-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2019-08-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208538-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2019-08-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208538-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2019-08-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208538-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2019-08-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208538-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2019-08-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208538-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2019-08-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208538-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2019-08-14	`b00525d2431f…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208538-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2019-08-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208538-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2019-08-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208538-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2019-08-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208538-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2019-08-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208538-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2019-08-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208538-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2019-08-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208538-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2019-08-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208538-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2019-08-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208538-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2019-08-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208538-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2019-08-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208538-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2019-08-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208538-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2019-08-14	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208538-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2019-08-14	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A208538-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2019-08-14	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A208538-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208538-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208538-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208538-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208538-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208538-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208538-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208538-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208538-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208538-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208538-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208538-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208538-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208538-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208538-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208538-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208538-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208538-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208538-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208538-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208538-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208538-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208538-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208538-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208538-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208538-001	AP	1	`b00525d2431f…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208538-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208538-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208538-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208538-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208538-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208538-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208538-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208538-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208538-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208538-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208538-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208538-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208538-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A208538-001	AP	1	`a50c72e98297…`

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	10 mg/mL

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
017023a9-00f0-4284-861f-a3634d4fdb17	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
ab3d10ea-fe48-4811-8e72-bb51600b35f9	Product name	5	20230103
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
9cb9173b-3912-466b-8256-366e71d49fce	Product name	1	20190402
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
48747306-602a-42cc-957b-5b0c69158eee	Product name	1	20180604
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
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
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
684ea482-2e8b-14af-5664-b98f1e402036	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
b060cc1a-fe47-856b-0b77-4448b5963de8	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578b	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68083-211-01	Esmolol Hydrochloride	10 mL in 1 VIAL	INJECTION	10		5
68083-211-25	Esmolol Hydrochloride	25 in 1 CARTON	INJECTION	25		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68083-211	ESMOLOL HYDROCHLORIDE INJECTION [GLAND PHARMA LIMITED]	5	Current NDC, Legacy NDC, 2 package rows	20230713_017023a9-00f0-4284-861f-a3634d4fdb17.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Esmolol Hydrochloride	ESMOLOL HYDROCHLORIDE	Gland Pharma Limited	017023a9-00f0-4284-861f-a3634d4fdb17	2023-06-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208538 application number: ANDA208538 ndc (package): 68083-211-25 ndc (product): 68083-211 ndc11 (package): 68083021125

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	017023a9-00f0-4284-861f-a3634d4fdb17	5
1736546	10 ML esmolol hydrochloride 10 MG/ML Injection	SCD	017023a9-00f0-4284-861f-a3634d4fdb17	5
1736546	esmolol HCl 100 MG per 10 ML Injection	SY	017023a9-00f0-4284-861f-a3634d4fdb17	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68083-211-25	68083021125	25 VIAL in 1 CARTON (68083-211-25) / 10 mL in 1 VIAL (68083-211-01)	25 vial	2019-08-19	0000-00-00	No	No	Current