Home NDC 25021-308 esmolol hydrochloride
Product NDC 25021-308
11-digit product format 250210308
Labeler code 25021
Product ID 25021-308_f18c8af9-7dbb-44c2-b1eb-9d0d908f9c9b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name esmolol hydrochloride
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Sagent Pharmaceuticals
Application ANDA207107
Marketing category ANDA
Marketing start 2019-07-15
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 A207107-001 ESMOLOL HYDROCHLORIDE ESMOLOL HYDROCHLORIDE 1GM/100ML INJECTABLE / INJECTION AP 2018-06-08 A207107-002 ESMOLOL HYDROCHLORIDE ESMOLOL HYDROCHLORIDE 2GM/100ML INJECTABLE / INJECTION AP 2018-06-08
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 3 · 84 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 A207107-001 ESMOLOL HYDROCHLORIDE 1GM/100ML INJECTABLE / INJECTION AP 2018-06-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A207107-002 ESMOLOL HYDROCHLORIDE 2GM/100ML INJECTABLE / INJECTION AP 2018-06-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A207107-001 ESMOLOL HYDROCHLORIDE 1GM/100ML INJECTABLE / INJECTION AP 2018-06-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207107-002 ESMOLOL HYDROCHLORIDE 2GM/100ML INJECTABLE / INJECTION AP 2018-06-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207107-001 ESMOLOL HYDROCHLORIDE 1GM/100ML INJECTABLE / INJECTION AP 2018-06-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207107-002 ESMOLOL HYDROCHLORIDE 2GM/100ML INJECTABLE / INJECTION AP 2018-06-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207107-001 ESMOLOL HYDROCHLORIDE 1GM/100ML INJECTABLE / INJECTION AP 2018-06-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207107-002 ESMOLOL HYDROCHLORIDE 2GM/100ML INJECTABLE / INJECTION AP 2018-06-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207107-001 ESMOLOL HYDROCHLORIDE 1GM/100ML INJECTABLE / INJECTION AP 2018-06-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207107-002 ESMOLOL HYDROCHLORIDE 2GM/100ML INJECTABLE / INJECTION AP 2018-06-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207107-001 ESMOLOL HYDROCHLORIDE 1GM/100ML INJECTABLE / INJECTION AP 2018-06-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207107-002 ESMOLOL HYDROCHLORIDE 2GM/100ML INJECTABLE / INJECTION AP 2018-06-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207107-001 ESMOLOL HYDROCHLORIDE 1GM/100ML INJECTABLE / INJECTION AP 2018-06-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207107-002 ESMOLOL HYDROCHLORIDE 2GM/100ML INJECTABLE / INJECTION AP 2018-06-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207107-001 ESMOLOL HYDROCHLORIDE 1GM/100ML INJECTABLE / INJECTION AP 2018-06-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207107-002 ESMOLOL HYDROCHLORIDE 2GM/100ML INJECTABLE / INJECTION AP 2018-06-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207107-001 ESMOLOL HYDROCHLORIDE 1GM/100ML INJECTABLE / INJECTION AP 2018-06-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207107-002 ESMOLOL HYDROCHLORIDE 2GM/100ML INJECTABLE / INJECTION AP 2018-06-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207107-001 ESMOLOL HYDROCHLORIDE 1GM/100ML INJECTABLE / INJECTION AP 2018-06-08 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207107-002 ESMOLOL HYDROCHLORIDE 2GM/100ML INJECTABLE / INJECTION AP 2018-06-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207107-001 ESMOLOL HYDROCHLORIDE 1GM/100ML INJECTABLE / INJECTION AP 2018-06-08 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A207107-002 ESMOLOL HYDROCHLORIDE 2GM/100ML INJECTABLE / INJECTION AP 2018-06-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207107-001 ESMOLOL HYDROCHLORIDE 1GM/100ML INJECTABLE / INJECTION AP 2018-06-08 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207107-002 ESMOLOL HYDROCHLORIDE 2GM/100ML INJECTABLE / INJECTION AP 2018-06-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207107-001 ESMOLOL HYDROCHLORIDE 1GM/100ML INJECTABLE / INJECTION AP 2018-06-08 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207107-002 ESMOLOL HYDROCHLORIDE 2GM/100ML INJECTABLE / INJECTION AP 2018-06-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207107-001 ESMOLOL HYDROCHLORIDE 1GM/100ML INJECTABLE / INJECTION AP 2018-06-08 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207107-002 ESMOLOL HYDROCHLORIDE 2GM/100ML INJECTABLE / INJECTION AP 2018-06-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A207107-001 ESMOLOL HYDROCHLORIDE 1GM/100ML INJECTABLE / INJECTION AP 2018-06-08 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A207107-002 ESMOLOL HYDROCHLORIDE 2GM/100ML INJECTABLE / INJECTION AP 2018-06-08 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207107-001 ESMOLOL HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2018-06-08 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207107-002 ESMOLOL HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 2018-06-08 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A207107-001 ESMOLOL HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2018-06-08 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A207107-002 ESMOLOL HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 2018-06-08 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A207107-001 ESMOLOL HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2018-06-08 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A207107-002 ESMOLOL HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 2018-06-08 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A207107-001 ESMOLOL HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2018-06-08 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A207107-002 ESMOLOL HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 2018-06-08 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A207107-001 ESMOLOL HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2018-06-08 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A207107-002 ESMOLOL HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 2018-06-08 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 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 · 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 25021-308-84 esmolol hydrochloride 10 in 1 CARTON INJECTION, SOLUTION 10 8 25021-308-84 esmolol hydrochloride 250 mL in 1 BAG INJECTION, SOLUTION 250 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 25021-308 ESMOLOL HYDROCHLORIDE INJECTION, SOLUTION [SAGENT PHARMACEUTICALS] 8 Current NDC, Legacy NDC, 2 package rows 20250313_f12fb0fd-fa05-49fc-b5e3-a2050b816ef2.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 25021-308-84 25021030884 10 BAG in 1 CARTON (25021-308-84) / 250 mL in 1 BAG 10 bag 2019-07-15 0000-00-00 No No Current