Esmolol Hydrochloride

Product NDC: 63323-661
11-digit product format: 633230661
Labeler code: 63323
Product ID: 63323-661_961c04d5-1f12-4095-a4b9-1842574f7f97
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ESMOLOL HYDROCHLORIDE
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Fresenius Kabi USA, LLC
Application: ANDA076573
Marketing category: ANDA
Marketing start: 2004-11-30
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 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…`

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
fdc9cea8-0eb4-4930-9e1c-d44bfa9346d2	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
63323-661-04	Esmolol Hydrochloride	10 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION	10		6
63323-661-14	Esmolol Hydrochloride	25 in 1 TRAY	INJECTION, SOLUTION	25		6

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ESMOLOL HYDROCHLORIDE	ACTIVE INGREDIENT	V05260LC8D	ESMOLOL HYDROCHLORIDE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	2
ESMOLOL	ACTIVE MOIETY	MDY902UXSR	ESMOLOL HYDROCHLORIDE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	2
ACETIC ACID	INACTIVE INGREDIENT	Q40Q9N063P	ESMOLOL HYDROCHLORIDE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	2
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	ESMOLOL HYDROCHLORIDE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	2
SODIUM ACETATE	INACTIVE INGREDIENT	4550K0SC9B	ESMOLOL HYDROCHLORIDE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	2
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	ESMOLOL HYDROCHLORIDE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63323-661	ESMOLOL HYDROCHLORIDE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	6	Current NDC, 2 package rows	20241127_fdc9cea8-0eb4-4930-9e1c-d44bfa9346d2.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 · 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): 63323-661
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

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	fdc9cea8-0eb4-4930-9e1c-d44bfa9346d2	6
1736546	10 ML esmolol hydrochloride 10 MG/ML Injection	SCD	fdc9cea8-0eb4-4930-9e1c-d44bfa9346d2	6
1736546	esmolol HCl 100 MG per 10 ML Injection	SY	fdc9cea8-0eb4-4930-9e1c-d44bfa9346d2	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
63323-661-04	63323066104	10 mL in 1 VIAL, SINGLE-DOSE	10 ml				Historical
63323-661-14	63323066114	25 VIAL, SINGLE-DOSE in 1 TRAY (63323-661-14) / 10 mL in 1 VIAL, SINGLE-DOSE (63323-661-04)		2025-01-13	No	No	Current