Home NDC 0404-9785 Esmolol Hydrochloride
Product NDC 0404-9785
11-digit product format 004049785
Labeler code 0404
Product ID 0404-9785_20a0bd84-7968-459c-8218-2b2c98beb7d0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name esmolol hydrochloride
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Henry Schein, Inc.
Application ANDA076474
Marketing category ANDA
Marketing start 2025-06-10
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A076474-001 ESMOLOL HYDROCHLORIDE ESMOLOL HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2005-05-02
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A076474-001 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.
Product history page 1 of 2 · 42 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 2026-08-18 06:07:40 2026-07 A076474-001 ESMOLOL HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2005-05-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076474-001 ESMOLOL HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2005-05-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076474-001 ESMOLOL HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2005-05-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076474-001 ESMOLOL HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2005-05-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076474-001 ESMOLOL HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2005-05-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076474-001 ESMOLOL HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2005-05-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076474-001 ESMOLOL HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2005-05-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076474-001 ESMOLOL HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2005-05-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076474-001 ESMOLOL HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2005-05-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076474-001 ESMOLOL HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2005-05-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076474-001 ESMOLOL HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2005-05-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076474-001 ESMOLOL HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2005-05-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076474-001 ESMOLOL HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2005-05-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076474-001 ESMOLOL HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2005-05-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076474-001 ESMOLOL HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2005-05-02 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076474-001 ESMOLOL HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2005-05-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076474-001 ESMOLOL HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2005-05-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076474-001 ESMOLOL HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2005-05-02 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076474-001 ESMOLOL HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2005-05-02 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076474-001 ESMOLOL HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2005-05-02 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076474-001 ESMOLOL HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2005-05-02 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A076474-001 ESMOLOL HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2005-05-02 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A076474-001 ESMOLOL HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2005-05-02 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A076474-001 ESMOLOL HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2005-05-02 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A076474-001 ESMOLOL HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2005-05-02 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A076474-001 ESMOLOL HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2005-05-02 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A076474-001 ESMOLOL HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2005-05-02 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A076474-001 ESMOLOL HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2005-05-02 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A076474-001 ESMOLOL HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2005-05-02 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A076474-001 ESMOLOL HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2005-05-02 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A076474-001 ESMOLOL HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2005-05-02 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A076474-001 ESMOLOL HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2005-05-02 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A076474-001 ESMOLOL HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2005-05-02 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A076474-001 ESMOLOL HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2005-05-02 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A076474-001 ESMOLOL HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2005-05-02 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A076474-001 ESMOLOL HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2005-05-02 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A076474-001 ESMOLOL HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2005-05-02 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A076474-001 ESMOLOL HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2005-05-02 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A076474-001 ESMOLOL HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2005-05-02 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A076474-001 ESMOLOL HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2005-05-02 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 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 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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0404-9785-10 Esmolol Hydrochloride 10 mL in 1 VIAL INJECTION, SOLUTION 10 2 0404-9785-10 Esmolol Hydrochloride 1 in 1 BAG INJECTION, SOLUTION 1 2
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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 0404-9785-10 00404978510 1 VIAL in 1 BAG (0404-9785-10) / 10 mL in 1 VIAL 1 vial 2025-06-10 No No Current