Esmolol Hydrochloride in Water

Product NDC
44567-811
11-digit product format
445670811
Labeler code
44567
Product ID
44567-811_5b27f55a-7c85-40fc-97cd-84e1d352cd35
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Esmolol Hydrochloride
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
WG Critical Care, LLC
Application
NDA205703
Marketing category
NDA
Marketing start
2017-12-04
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
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N205703-001ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINERESMOLOL HYDROCHLORIDE2.5GM/250ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2016-04-07
N205703-002ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINERESMOLOL HYDROCHLORIDE2GM/100ML (20MG/ML)SOLUTION / INTRAVENOUSRLD, RS2016-04-07

Orange Book patents#

Current patent rows page 1 of 1 · 4 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N205703-00188290542033-03-15Drug product2016-05-18
N205703-00188355052033-03-15Drug product2016-05-18
N205703-00288290542033-03-15Drug product2016-05-18
N205703-00288355052033-03-15Drug product2016-05-18

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 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N205703-001ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER2.5GM/250ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2016-04-0784e616aacf4f…
2026-09-14 22:38:342026-08N205703-002ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER2GM/100ML (20MG/ML)SOLUTION / INTRAVENOUSRLD, RS2016-04-0784e616aacf4f…
2026-08-18 06:07:402026-07N205703-001ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER2.5GM/250ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2016-04-07caaa826d4ba7…
2026-08-18 06:07:402026-07N205703-002ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER2GM/100ML (20MG/ML)SOLUTION / INTRAVENOUSRLD, RS2016-04-07caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N205703-001ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER2.5GM/250ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2016-04-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N205703-002ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER2GM/100ML (20MG/ML)SOLUTION / INTRAVENOUSRLD, RS2016-04-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N205703-001ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER2.5GM/250ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2016-04-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N205703-002ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER2GM/100ML (20MG/ML)SOLUTION / INTRAVENOUSRLD, RS2016-04-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08N205703-001ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER2.5GM/250ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2016-04-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08N205703-002ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER2GM/100ML (20MG/ML)SOLUTION / INTRAVENOUSRLD, RS2016-04-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205703-001ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER2.5GM/250ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2016-04-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205703-002ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER2GM/100ML (20MG/ML)SOLUTION / INTRAVENOUSRLD, RS2016-04-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N205703-001ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER2.5GM/250ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2016-04-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N205703-002ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER2GM/100ML (20MG/ML)SOLUTION / INTRAVENOUSRLD, RS2016-04-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N205703-001ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER2.5GM/250ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2016-04-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N205703-002ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER2GM/100ML (20MG/ML)SOLUTION / INTRAVENOUSRLD, RS2016-04-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N205703-001ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER2.5GM/250ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2016-04-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N205703-002ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER2GM/100ML (20MG/ML)SOLUTION / INTRAVENOUSRLD, RS2016-04-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N205703-001ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER2.5GM/250ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2016-04-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N205703-002ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER2GM/100ML (20MG/ML)SOLUTION / INTRAVENOUSRLD, RS2016-04-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N205703-001ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER2.5GM/250ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2016-04-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N205703-002ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER2GM/100ML (20MG/ML)SOLUTION / INTRAVENOUSRLD, RS2016-04-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N205703-001ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER2.5GM/250ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2016-04-07d06236e962d9…
2024-10-29 15:01 UTC2024-10N205703-002ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER2GM/100ML (20MG/ML)SOLUTION / INTRAVENOUSRLD, RS2016-04-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N205703-001ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER2.5GM/250ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2016-04-0779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N205703-002ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER2GM/100ML (20MG/ML)SOLUTION / INTRAVENOUSRLD, RS2016-04-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N205703-001ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER2.5GM/250ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2016-04-07301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N205703-002ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER2GM/100ML (20MG/ML)SOLUTION / INTRAVENOUSRLD, RS2016-04-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N205703-001ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER2.5GM/250ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2016-04-071e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N205703-002ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER2GM/100ML (20MG/ML)SOLUTION / INTRAVENOUSRLD, RS2016-04-071e350fbaab3a…
2024-05-31 18:47 UTC2024-05N205703-001ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER2.5GM/250ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2016-04-078072bd15b7f6…
2024-05-31 18:47 UTC2024-05N205703-002ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER2GM/100ML (20MG/ML)SOLUTION / INTRAVENOUSRLD, RS2016-04-078072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N205703-001ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER2.5GM/250ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2016-04-075c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N205703-002ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER2GM/100ML (20MG/ML)SOLUTION / INTRAVENOUSRLD, RS2016-04-075c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N205703-001ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER2.5GM/250ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2016-04-075d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N205703-002ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER2GM/100ML (20MG/ML)SOLUTION / INTRAVENOUSRLD, RS2016-04-075d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N205703-001ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER2.5GM/250ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2016-04-074b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N205703-002ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER2GM/100ML (20MG/ML)SOLUTION / INTRAVENOUSRLD, RS2016-04-074b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N205703-001ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER2.5GM/250ML (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2016-04-0774a2ff9319b5…
2019-12-13 00:20 UTC2019-12N205703-002ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER2GM/100ML (20MG/ML)SOLUTION / INTRAVENOUSRLD, RS2016-04-0774a2ff9319b5…

Observed Orange Book patent history#

Patent history page 1 of 6 · 208 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N205703-00188290542033-03-15Drug product2016-05-1884e616aacf4f…
2026-09-14 22:38:342026-08N205703-00188355052033-03-15Drug product2016-05-1884e616aacf4f…
2026-09-14 22:38:342026-08N205703-00288290542033-03-15Drug product2016-05-1884e616aacf4f…
2026-09-14 22:38:342026-08N205703-00288355052033-03-15Drug product2016-05-1884e616aacf4f…
2026-08-18 06:07:402026-07N205703-00188290542033-03-15Drug product2016-05-18caaa826d4ba7…
2026-08-18 06:07:402026-07N205703-00188355052033-03-15Drug product2016-05-18caaa826d4ba7…
2026-08-18 06:07:402026-07N205703-00288290542033-03-15Drug product2016-05-18caaa826d4ba7…
2026-08-18 06:07:402026-07N205703-00288355052033-03-15Drug product2016-05-18caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N205703-00188290542033-03-15Drug product2016-05-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N205703-00188355052033-03-15Drug product2016-05-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N205703-00288290542033-03-15Drug product2016-05-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N205703-00288355052033-03-15Drug product2016-05-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N205703-00188290542033-03-15Drug product2016-05-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N205703-00188355052033-03-15Drug product2016-05-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N205703-00288290542033-03-15Drug product2016-05-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N205703-00288355052033-03-15Drug product2016-05-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08N205703-00188290542033-03-15Drug product2016-05-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08N205703-00188355052033-03-15Drug product2016-05-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08N205703-00288290542033-03-15Drug product2016-05-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08N205703-00288355052033-03-15Drug product2016-05-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205703-00188290542033-03-15Drug product2016-05-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205703-00188355052033-03-15Drug product2016-05-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205703-00288290542033-03-15Drug product2016-05-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205703-00288355052033-03-15Drug product2016-05-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N205703-00188290542033-03-15Drug product2016-05-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N205703-00188355052033-03-15Drug product2016-05-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N205703-00288290542033-03-15Drug product2016-05-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N205703-00288355052033-03-15Drug product2016-05-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N205703-00188290542033-03-15Drug product2016-05-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N205703-00188355052033-03-15Drug product2016-05-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N205703-00288290542033-03-15Drug product2016-05-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N205703-00288355052033-03-15Drug product2016-05-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N205703-00188290542033-03-15Drug product2016-05-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N205703-00188355052033-03-15Drug product2016-05-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N205703-00288290542033-03-15Drug product2016-05-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N205703-00288355052033-03-15Drug product2016-05-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N205703-00188290542033-03-15Drug product2016-05-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N205703-00188355052033-03-15Drug product2016-05-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N205703-00288290542033-03-15Drug product2016-05-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N205703-00288355052033-03-15Drug product2016-05-185bbf6a4d5a75…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Esmolol Hydrochloride in Water
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ESMOLOL HYDROCHLORIDE10 mg/mL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ab3d10ea-fe48-4811-8e72-bb51600b35f9Product name520230103
9cb9173b-3912-466b-8256-366e71d49fceProduct name120190402

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44567-811-10Esmolol Hydrochloride in Water250 mL in 1 BAGINJECTION25010
44567-811-10Esmolol Hydrochloride in Water10 in 1 CARTONINJECTION1010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
44567-811-10ML - Milliliter44567-81161037f42-a206-474d-8de3-699cca0cba2a12018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44567-811ESMOLOL HYDROCHLORIDE IN WATER (ESMOLOL HYDROCHLORIDE) INJECTION [WG CRITICAL CARE, LLC]10Current NDC, Legacy NDC, 2 package rows20240809_60b10020-f802-4fef-a487-0f11eca246c5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979432esmolol HCl 2000 MG in 100 ML InjectionPSN60b10020-f802-4fef-a487-0f11eca246c510
1736541esmolol HCl 2500 MG in 250 ML InjectionPSN60b10020-f802-4fef-a487-0f11eca246c510
979432100 ML esmolol hydrochloride 20 MG/ML InjectionSCD60b10020-f802-4fef-a487-0f11eca246c510
1736541250 ML esmolol hydrochloride 10 MG/ML InjectionSCD60b10020-f802-4fef-a487-0f11eca246c510
979432esmolol HCl 2000 MG per 100 ML InjectionSY60b10020-f802-4fef-a487-0f11eca246c510
1736541esmolol HCl 2500 MG per 250 ML InjectionSY60b10020-f802-4fef-a487-0f11eca246c510

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
44567-811-104456708111010 BAG in 1 CARTON (44567-811-10) / 250 mL in 1 BAG10 bag2017-12-040000-00-00NoNoCurrent