Home NDC 44567-451-10 Esmolol Hydrochloride
Product NDC 44567-451
Requested package NDC 44567-451-10
11-digit product format 445670451
Labeler code 44567
Product ID 44567-451_2ee062ee-e28c-4bd7-96b3-e02e3e425d8f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Esmolol Hydrochloride in Sodium Chloride
Dosage form INJECTION
Route INTRAVENOUS
Labeler WG Critical Care, LLC
Application ANDA214172
Marketing category ANDA
Marketing start 2022-12-07
Substance ESMOLOL HYDROCHLORIDE
Active strength 20 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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A214172-001 ESMOLOL HYDROCHLORIDE ESMOLOL HYDROCHLORIDE 1GM/100ML INJECTABLE / INJECTION AP 2022-12-02 A214172-002 ESMOLOL HYDROCHLORIDE ESMOLOL HYDROCHLORIDE 2GM/100ML INJECTABLE / INJECTION AP 2022-12-02
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 · 48 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A214172-001 ESMOLOL HYDROCHLORIDE 1GM/100ML INJECTABLE / INJECTION AP 2022-12-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214172-002 ESMOLOL HYDROCHLORIDE 2GM/100ML INJECTABLE / INJECTION AP 2022-12-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214172-001 ESMOLOL HYDROCHLORIDE 1GM/100ML INJECTABLE / INJECTION AP 2022-12-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214172-002 ESMOLOL HYDROCHLORIDE 2GM/100ML INJECTABLE / INJECTION AP 2022-12-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214172-001 ESMOLOL HYDROCHLORIDE 1GM/100ML INJECTABLE / INJECTION AP 2022-12-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214172-002 ESMOLOL HYDROCHLORIDE 2GM/100ML INJECTABLE / INJECTION AP 2022-12-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214172-001 ESMOLOL HYDROCHLORIDE 1GM/100ML INJECTABLE / INJECTION AP 2022-12-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214172-002 ESMOLOL HYDROCHLORIDE 2GM/100ML INJECTABLE / INJECTION AP 2022-12-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214172-001 ESMOLOL HYDROCHLORIDE 1GM/100ML INJECTABLE / INJECTION AP 2022-12-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214172-002 ESMOLOL HYDROCHLORIDE 2GM/100ML INJECTABLE / INJECTION AP 2022-12-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214172-001 ESMOLOL HYDROCHLORIDE 1GM/100ML INJECTABLE / INJECTION AP 2022-12-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214172-002 ESMOLOL HYDROCHLORIDE 2GM/100ML INJECTABLE / INJECTION AP 2022-12-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214172-001 ESMOLOL HYDROCHLORIDE 1GM/100ML INJECTABLE / INJECTION AP 2022-12-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214172-002 ESMOLOL HYDROCHLORIDE 2GM/100ML INJECTABLE / INJECTION AP 2022-12-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214172-001 ESMOLOL HYDROCHLORIDE 1GM/100ML INJECTABLE / INJECTION AP 2022-12-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214172-002 ESMOLOL HYDROCHLORIDE 2GM/100ML INJECTABLE / INJECTION AP 2022-12-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214172-001 ESMOLOL HYDROCHLORIDE 1GM/100ML INJECTABLE / INJECTION AP 2022-12-02 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214172-002 ESMOLOL HYDROCHLORIDE 2GM/100ML INJECTABLE / INJECTION AP 2022-12-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A214172-001 ESMOLOL HYDROCHLORIDE 1GM/100ML INJECTABLE / INJECTION AP 2022-12-02 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A214172-002 ESMOLOL HYDROCHLORIDE 2GM/100ML INJECTABLE / INJECTION AP 2022-12-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214172-001 ESMOLOL HYDROCHLORIDE 1GM/100ML INJECTABLE / INJECTION AP 2022-12-02 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214172-002 ESMOLOL HYDROCHLORIDE 2GM/100ML INJECTABLE / INJECTION AP 2022-12-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214172-001 ESMOLOL HYDROCHLORIDE 1GM/100ML INJECTABLE / INJECTION AP 2022-12-02 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214172-002 ESMOLOL HYDROCHLORIDE 2GM/100ML INJECTABLE / INJECTION AP 2022-12-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214172-001 ESMOLOL HYDROCHLORIDE 1GM/100ML INJECTABLE / INJECTION AP 2022-12-02 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214172-002 ESMOLOL HYDROCHLORIDE 2GM/100ML INJECTABLE / INJECTION AP 2022-12-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A214172-001 ESMOLOL HYDROCHLORIDE 1GM/100ML INJECTABLE / INJECTION AP 2022-12-02 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A214172-002 ESMOLOL HYDROCHLORIDE 2GM/100ML INJECTABLE / INJECTION AP 2022-12-02 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A214172-001 ESMOLOL HYDROCHLORIDE 1GM/100ML INJECTABLE / INJECTION AP 2022-12-02 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A214172-002 ESMOLOL HYDROCHLORIDE 2GM/100ML INJECTABLE / INJECTION AP 2022-12-02 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A214172-001 ESMOLOL HYDROCHLORIDE 1GM/100ML INJECTABLE / INJECTION AP 2022-12-02 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A214172-002 ESMOLOL HYDROCHLORIDE 2GM/100ML INJECTABLE / INJECTION AP 2022-12-02 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A214172-001 ESMOLOL HYDROCHLORIDE 1GM/100ML INJECTABLE / INJECTION AP 2022-12-02 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A214172-002 ESMOLOL HYDROCHLORIDE 2GM/100ML INJECTABLE / INJECTION AP 2022-12-02 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A214172-001 ESMOLOL HYDROCHLORIDE 1GM/100ML INJECTABLE / INJECTION AP 2022-12-02 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A214172-002 ESMOLOL HYDROCHLORIDE 2GM/100ML INJECTABLE / INJECTION AP 2022-12-02 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A214172-001 ESMOLOL HYDROCHLORIDE 1GM/100ML INJECTABLE / INJECTION AP 2022-12-02 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A214172-002 ESMOLOL HYDROCHLORIDE 2GM/100ML INJECTABLE / INJECTION AP 2022-12-02 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A214172-001 ESMOLOL HYDROCHLORIDE 1GM/100ML INJECTABLE / INJECTION AP 2022-12-02 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A214172-002 ESMOLOL HYDROCHLORIDE 2GM/100ML INJECTABLE / INJECTION AP 2022-12-02 a67488948f0b…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 48 observed states.
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 20 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 979432 Internal RxNorm lookup 1736541 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 44567-451-01 Esmolol Hydrochloride 100 mL in 1 BAG INJECTION 100 5 44567-451-10 Esmolol Hydrochloride 10 in 1 CARTON INJECTION 10 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 44567-451 ESMOLOL HYDROCHLORIDE (ESMOLOL HYDROCHLORIDE IN SODIUM CHLORIDE) INJECTION [WG CRITICAL CARE, LLC] 4 Current NDC, Legacy NDC, 2 package rows 20240620_59ba978b-a393-421c-9a67-77e690249d88.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 44567-451-10 44567045110 10 BAG in 1 CARTON (44567-451-10) / 100 mL in 1 BAG (44567-451-01) 10 bag 2022-12-07 0000-00-00 No No Current