Home NDC 44567-450 Esmolol Hydrochloride
Product NDC 44567-450
11-digit product format 445670450
Labeler code 44567
Product ID 44567-450_f86485df-3ef9-4fba-b1b6-52f359e4f683
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 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-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 · 52 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 2026-09-14 22:38:34 2026-08 A214172-001 ESMOLOL HYDROCHLORIDE 1GM/100ML INJECTABLE / INJECTION AP 2022-12-02 84e616aacf4f…2026-09-14 22:38:34 2026-08 A214172-002 ESMOLOL HYDROCHLORIDE 2GM/100ML INJECTABLE / INJECTION AP 2022-12-02 84e616aacf4f…2026-08-18 06:07:40 2026-07 A214172-001 ESMOLOL HYDROCHLORIDE 1GM/100ML INJECTABLE / INJECTION AP 2022-12-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A214172-002 ESMOLOL HYDROCHLORIDE 2GM/100ML INJECTABLE / INJECTION AP 2022-12-02 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 52 observed states.
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
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ESMOLOL HYDROCHLORIDE 10 mg/mL
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 44567-450-01 Esmolol Hydrochloride 250 mL in 1 BAG INJECTION 250 5 44567-450-10 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 44567-450 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
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 44567-450-01 44567045001 250 mL in 1 BAG 250 ml Historical 44567-450-10 44567045010 10 BAG in 1 CARTON (44567-450-10) / 250 mL in 1 BAG (44567-450-01) 10 bag 2022-12-07 0000-00-00 No No Current