Esmolol Hydrochloride

Product NDC
55150-194
11-digit product format
551500194
Labeler code
55150
Product ID
55150-194_5aebd586-47c6-4e19-88e3-ef0ecb1cc875
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Esmolol Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Eugia US LLC
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A205520-001ESMOLOL HYDROCHLORIDEESMOLOL HYDROCHLORIDE10MG/MLINJECTABLE / INJECTIONAP2015-07-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A205520-001AP

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A205520-001ESMOLOL HYDROCHLORIDE10MG/MLINJECTABLE / INJECTIONAP2015-07-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205520-001ESMOLOL HYDROCHLORIDE10MG/MLINJECTABLE / INJECTIONAP2015-07-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A205520-001ESMOLOL HYDROCHLORIDE10MG/MLINJECTABLE / INJECTIONAP2015-07-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205520-001ESMOLOL HYDROCHLORIDE10MG/MLINJECTABLE / INJECTIONAP2015-07-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205520-001ESMOLOL HYDROCHLORIDE10MG/MLINJECTABLE / INJECTIONAP2015-07-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205520-001ESMOLOL HYDROCHLORIDE10MG/MLINJECTABLE / INJECTIONAP2015-07-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205520-001ESMOLOL HYDROCHLORIDE10MG/MLINJECTABLE / INJECTIONAP2015-07-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205520-001ESMOLOL HYDROCHLORIDE10MG/MLINJECTABLE / INJECTIONAP2015-07-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205520-001ESMOLOL HYDROCHLORIDE10MG/MLINJECTABLE / INJECTIONAP2015-07-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205520-001ESMOLOL HYDROCHLORIDE10MG/MLINJECTABLE / INJECTIONAP2015-07-23d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205520-001ESMOLOL HYDROCHLORIDE10MG/MLINJECTABLE / INJECTIONAP2015-07-2379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205520-001ESMOLOL HYDROCHLORIDE10MG/MLINJECTABLE / INJECTIONAP2015-07-23301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205520-001ESMOLOL HYDROCHLORIDE10MG/MLINJECTABLE / INJECTIONAP2015-07-231e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205520-001ESMOLOL HYDROCHLORIDE10MG/MLINJECTABLE / INJECTIONAP2015-07-238072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205520-001ESMOLOL HYDROCHLORIDE10MG/MLINJECTABLE / INJECTIONAP2015-07-235c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A205520-001ESMOLOL HYDROCHLORIDE10MG/MLINJECTABLE / INJECTIONAP2015-07-235d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A205520-001ESMOLOL HYDROCHLORIDE10MG/MLINJECTABLE / INJECTIONAP2015-07-234b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A205520-001ESMOLOL HYDROCHLORIDE10MG/MLINJECTABLE / INJECTIONAP2015-07-2374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A205520-001ESMOLOL HYDROCHLORIDE10MG/MLINJECTABLE / INJECTIONAP2015-07-23bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A205520-001ESMOLOL HYDROCHLORIDE10MG/MLINJECTABLE / INJECTIONAP2015-07-23782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A205520-001ESMOLOL HYDROCHLORIDE10MG/MLINJECTABLE / INJECTIONAP2015-07-2387673890dc5c…
2021-03-12 10:30 UTC2021-03A205520-001ESMOLOL HYDROCHLORIDE10MG/MLINJECTABLE / INJECTIONAP2015-07-235aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A205520-001ESMOLOL HYDROCHLORIDE10MG/MLINJECTABLE / INJECTIONAP2015-07-238869cabd3fbd…
2020-11-12 02:37 UTC2020-11A205520-001ESMOLOL HYDROCHLORIDE10MG/MLINJECTABLE / INJECTIONAP2015-07-23c0c555d07b60…
2019-12-14 00:12 UTC2019-12A205520-001ESMOLOL HYDROCHLORIDE10MG/MLINJECTABLE / INJECTIONAP2015-07-233f01610625f2…
2019-09-15 20:21 UTC2019-09A205520-001ESMOLOL HYDROCHLORIDE10MG/MLINJECTABLE / INJECTIONAP2015-07-23b00525d2431f…
2019-07-19 19:46 UTC2019-07A205520-001ESMOLOL HYDROCHLORIDE10MG/MLINJECTABLE / INJECTIONAP2015-07-23ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A205520-001ESMOLOL HYDROCHLORIDE10MG/MLINJECTABLE / INJECTIONAP2015-07-236a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A205520-001ESMOLOL HYDROCHLORIDE10MG/MLINJECTABLE / INJECTIONAP2015-07-231c564ffb4f44…
2023-12-20 04:57 UTC2023-12A205520-001ESMOLOL HYDROCHLORIDE10MG/MLINJECTABLE / INJECTIONAP2015-07-23ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A205520-001ESMOLOL HYDROCHLORIDE10MG/MLINJECTABLE / INJECTIONAP2015-07-23a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A205520-001ESMOLOL HYDROCHLORIDE10MG/MLINJECTABLE / INJECTIONAP2015-07-239b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A205520-001ESMOLOL HYDROCHLORIDE10MG/MLINJECTABLE / INJECTIONAP2015-07-23a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A205520-001ESMOLOL HYDROCHLORIDE10MG/MLINJECTABLE / INJECTIONAP2015-07-233f0d92c62455…
2023-05-13 08:27 UTC2023-05A205520-001ESMOLOL HYDROCHLORIDE10MG/MLINJECTABLE / INJECTIONAP2015-07-23053a50430f4f…
2023-01-26 05:58 UTC2023-01A205520-001ESMOLOL HYDROCHLORIDE10MG/MLINJECTABLE / INJECTIONAP2015-07-233bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A205520-001ESMOLOL HYDROCHLORIDE10MG/MLINJECTABLE / INJECTIONAP2015-07-233a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A205520-001ESMOLOL HYDROCHLORIDE10MG/MLINJECTABLE / INJECTIONAP2015-07-23f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A205520-001ESMOLOL HYDROCHLORIDE10MG/MLINJECTABLE / INJECTIONAP2015-07-23e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A205520-001ESMOLOL HYDROCHLORIDE10MG/MLINJECTABLE / INJECTIONAP2015-07-23cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A205520-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205520-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A205520-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205520-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205520-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205520-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205520-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205520-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205520-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205520-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205520-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205520-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205520-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205520-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205520-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A205520-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A205520-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A205520-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A205520-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A205520-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A205520-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A205520-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A205520-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A205520-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A205520-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A205520-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A205520-001AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A205520-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A205520-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A205520-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A205520-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A205520-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A205520-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A205520-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A205520-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A205520-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A205520-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A205520-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A205520-001AP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A205520-001AP1cb3db0bc1861…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ESMOLOL HYDROCHLORIDE100 mg/10mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
V05260LC8DInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
979432Internal RxNorm lookup
1736541Internal RxNorm lookup
1736546Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ac22475d-2d78-469f-9435-b403ac4ee380Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
ab3d10ea-fe48-4811-8e72-bb51600b35f9Product name520230103
9cb9173b-3912-466b-8256-366e71d49fceProduct name120190402
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55150-194-10Esmolol Hydrochloride10 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION106
55150-194-10Esmolol Hydrochloride25 in 1 CARTONINJECTION, SOLUTION256

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55150-194-10ML - Milliliter55150-1947c2c4cca-763b-438c-a731-a36c4dde461612016-03-04

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55150-194ESMOLOL HYDROCHLORIDE INJECTION, SOLUTION ESMOLOL HYDROCHLORIDE (ESMOLOL HYDROCHLORIDE IN SODIUM CHLORIDE) INJECTION [EUGIA US LLC]6Current NDC, Legacy NDC, 2 package rows20240919_ac22475d-2d78-469f-9435-b403ac4ee380.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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Esmolol HydrochlorideESMOLOL HYDROCHLORIDEProPharma Distribution3853a26d-782d-f4e7-e063-6294a90a6e472025-12-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205520
application number: ANDA205520
Esmolol HydrochlorideESMOLOL HYDROCHLORIDEREMEDYREPACK INC.1f5707f2-a8a7-4a5f-b846-64585b5e3f9f2025-07-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205520
application number: ANDA205520
ESMOLOL HYDROCHLORIDEESMOLOL HYDROCHLORIDEHenry Schein, Inc.519cc19c-e2b6-4984-bfad-45276d4cf0e62025-01-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205520
application number: ANDA205520
Esmolol HydrochlorideESMOLOL HYDROCHLORIDEEugia US LLCac22475d-2d78-469f-9435-b403ac4ee3802024-09-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205520
application number: ANDA205520
ndc (product): 55150-194
ESMOLOL HYDROCHLORIDEESMOLOL HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirst9a52d2fd-e551-f8f1-e053-2995a90a6c092024-01-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205520
application number: ANDA205520
Esmolol HydrochlorideESMOLOL HYDROCHLORIDEMedical Purchasing Solutions, LLC6bb9921c-a0f9-309f-e053-2a91aa0a1e5e2023-05-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205520
application number: ANDA205520

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1736546esmolol HCl 100 MG in 10 ML InjectionPSNac22475d-2d78-469f-9435-b403ac4ee3806
979432esmolol HCl 2000 MG in 100 ML InjectionPSNac22475d-2d78-469f-9435-b403ac4ee3806
1736541esmolol HCl 2500 MG in 250 ML InjectionPSNac22475d-2d78-469f-9435-b403ac4ee3806
173654610 ML esmolol hydrochloride 10 MG/ML InjectionSCDac22475d-2d78-469f-9435-b403ac4ee3806
979432100 ML esmolol hydrochloride 20 MG/ML InjectionSCDac22475d-2d78-469f-9435-b403ac4ee3806
1736541250 ML esmolol hydrochloride 10 MG/ML InjectionSCDac22475d-2d78-469f-9435-b403ac4ee3806
1736546esmolol HCl 100 MG per 10 ML InjectionSYac22475d-2d78-469f-9435-b403ac4ee3806
979432esmolol HCl 2000 MG per 100 ML InjectionSYac22475d-2d78-469f-9435-b403ac4ee3806
1736541esmolol HCl 2500 MG per 250 ML InjectionSYac22475d-2d78-469f-9435-b403ac4ee3806
1736546esmolol HCl 100 MG in 10 ML InjectionPSN519cc19c-e2b6-4984-bfad-45276d4cf0e65
173654610 ML esmolol hydrochloride 10 MG/ML InjectionSCD519cc19c-e2b6-4984-bfad-45276d4cf0e65
1736546esmolol HCl 100 MG per 10 ML InjectionSY519cc19c-e2b6-4984-bfad-45276d4cf0e65
1736546esmolol HCl 100 MG in 10 ML InjectionPSN9a52d2fd-e551-f8f1-e053-2995a90a6c094
173654610 ML esmolol hydrochloride 10 MG/ML InjectionSCD9a52d2fd-e551-f8f1-e053-2995a90a6c094
1736546esmolol HCl 100 MG per 10 ML InjectionSY9a52d2fd-e551-f8f1-e053-2995a90a6c094
1736546esmolol HCl 100 MG in 10 ML InjectionPSN6bb9921c-a0f9-309f-e053-2a91aa0a1e5e3
1736546esmolol HCl 100 MG in 10 ML InjectionPSN3853a26d-782d-f4e7-e063-6294a90a6e473
173654610 ML esmolol hydrochloride 10 MG/ML InjectionSCD6bb9921c-a0f9-309f-e053-2a91aa0a1e5e3
173654610 ML esmolol hydrochloride 10 MG/ML InjectionSCD3853a26d-782d-f4e7-e063-6294a90a6e473
1736546esmolol HCl 100 MG per 10 ML InjectionSY6bb9921c-a0f9-309f-e053-2a91aa0a1e5e3
1736546esmolol HCl 100 MG per 10 ML InjectionSY3853a26d-782d-f4e7-e063-6294a90a6e473
1736546esmolol HCl 100 MG in 10 ML InjectionPSNd407833b-817e-4579-a226-0b02e1b497272
173654610 ML esmolol hydrochloride 10 MG/ML InjectionSCDd407833b-817e-4579-a226-0b02e1b497272
1736546esmolol HCl 100 MG per 10 ML InjectionSYd407833b-817e-4579-a226-0b02e1b497272
1736546esmolol HCl 100 MG in 10 ML InjectionPSN1f5707f2-a8a7-4a5f-b846-64585b5e3f9f1
173654610 ML esmolol hydrochloride 10 MG/ML InjectionSCD1f5707f2-a8a7-4a5f-b846-64585b5e3f9f1
1736546esmolol HCl 100 MG per 10 ML InjectionSY1f5707f2-a8a7-4a5f-b846-64585b5e3f9f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55150-194-105515001941025 VIAL, SINGLE-DOSE in 1 CARTON (55150-194-10) / 10 mL in 1 VIAL, SINGLE-DOSE2015-07-230000-00-00NoNoCurrent