Application 214172

Type: ANDA
Sponsor: HQ SPCLT PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ESMOLOL HYDROCHLORIDE	ESMOLOL HYDROCHLORIDE	INJECTABLE;INJECTION	10MG/ML	No	No
002	ESMOLOL HYDROCHLORIDE	ESMOLOL HYDROCHLORIDE	INJECTABLE;INJECTION	20MG/ML	No	No

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.

Application-product, TE code table
Application-product	TE code
A214172-001	AP
A214172-002	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 · 52 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A214172-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214172-002	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A214172-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214172-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214172-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214172-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214172-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214172-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214172-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214172-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214172-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214172-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214172-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214172-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214172-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214172-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214172-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214172-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214172-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214172-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214172-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214172-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214172-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214172-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214172-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214172-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214172-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214172-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214172-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214172-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214172-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A214172-002	AP	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214172-001	AP	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214172-002	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214172-001	AP	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A214172-002	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214172-001	AP	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A214172-002	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214172-001	AP	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214172-002	AP	1	`a72a2bbeb626…`

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 2 · 21 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Esmolol Hydrochloride	ESMOLOL HYDROCHLORIDE	REMEDYREPACK INC.	1f5707f2-a8a7-4a5f-b846-64585b5e3f9f	2026-09-10	Warnings, Adverse reactions	Name fallback brand name: Esmolol Hydrochloride generic name: ESMOLOL HYDROCHLORIDE
Brevibloc	ESMOLOL HYDROCHLORIDE	Henry Schein, Inc	38a8b23a-fca8-45f4-a09a-9c8b21f522cd	2026-08-06	Warnings, Adverse reactions	Name fallback generic name: ESMOLOL HYDROCHLORIDE
Esmolol Hydrochloride	ESMOLOL HYDROCHLORIDE	ProPharma Distribution	3853a26d-782d-f4e7-e063-6294a90a6e47	2025-12-18	Warnings, Adverse reactions	Name fallback brand name: Esmolol Hydrochloride generic name: ESMOLOL HYDROCHLORIDE
Esmolol Hydrochloride	ESMOLOL HYDROCHLORIDE	Henry Schein, Inc.	9c1e3a64-0ef0-4071-ad6f-63ff8789b198	2025-06-18	Warnings, Adverse reactions	Name fallback brand name: Esmolol Hydrochloride generic name: ESMOLOL HYDROCHLORIDE
BREVIBLOC	ESMOLOL HYDROCHLORIDE	Baxter Healthcare Company	220a07b8-5c68-41a3-8705-fd91f14c50b4	2025-03-14	Warnings, Adverse reactions	Name fallback generic name: ESMOLOL HYDROCHLORIDE
BREVIBLOC	ESMOLOL HYDROCHLORIDE	Baxter Healthcare Company	9c593cdb-cdfe-4492-8862-9b05116aa25e	2025-03-14	Warnings, Adverse reactions	Name fallback generic name: ESMOLOL HYDROCHLORIDE
Brevibloc	ESMOLOL HYDROCHLORIDE	Baxter Healthcare Company	595cc3d5-1306-4828-aefa-5595219ffd62	2025-03-14	Warnings, Adverse reactions	Name fallback generic name: ESMOLOL HYDROCHLORIDE
Esmolol Hydrochloride	ESMOLOL HYDROCHLORIDE	Mylan Institutional LLC	94f069f9-dd52-4a69-a103-ebdb4294f088	2025-02-27	Warnings, Adverse reactions	Name fallback brand name: Esmolol Hydrochloride generic name: ESMOLOL HYDROCHLORIDE
ESMOLOL HYDROCHLORIDE	ESMOLOL HYDROCHLORIDE	Henry Schein, Inc.	519cc19c-e2b6-4984-bfad-45276d4cf0e6	2025-01-27	Warnings, Adverse reactions	Name fallback brand name: ESMOLOL HYDROCHLORIDE generic name: ESMOLOL HYDROCHLORIDE
ESMOLOL HYDROCHLORIDE	ESMOLOL HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	9a3e69ab-3ffe-33af-e053-2a95a90a6524	2025-01-08	Warnings, Adverse reactions	Name fallback brand name: ESMOLOL HYDROCHLORIDE generic name: ESMOLOL HYDROCHLORIDE
Esmolol Hydrochloride	ESMOLOL HYDROCHLORIDE	Fresenius Kabi USA, LLC	fdc9cea8-0eb4-4930-9e1c-d44bfa9346d2	2024-11-14	Warnings, Adverse reactions	Name fallback brand name: Esmolol Hydrochloride generic name: ESMOLOL HYDROCHLORIDE
Esmolol Hydrochloride	ESMOLOL HYDROCHLORIDE	Eugia US LLC	ac22475d-2d78-469f-9435-b403ac4ee380	2024-09-17	Warnings, Adverse reactions	Name fallback brand name: Esmolol Hydrochloride generic name: ESMOLOL HYDROCHLORIDE
Esmolol Hydrochloride	ESMOLOL HYDROCHLORIDE IN SODIUM CHLORIDE	Amneal Pharmaceuticals LLC	4cfdfa50-579b-43e7-bc0a-e831d3099bfd	2024-04-19	Warnings, Adverse reactions	Name fallback brand name: Esmolol Hydrochloride
ESMOLOL HYDROCHLORIDE	ESMOLOL HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	789730fa-eaca-4986-e053-2a91aa0a5339	2024-02-19	Warnings, Adverse reactions	Name fallback brand name: ESMOLOL HYDROCHLORIDE generic name: ESMOLOL HYDROCHLORIDE
ESMOLOL HYDROCHLORIDE	ESMOLOL HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	9a52d2fd-e551-f8f1-e053-2995a90a6c09	2024-01-29	Warnings, Adverse reactions	Name fallback brand name: ESMOLOL HYDROCHLORIDE generic name: ESMOLOL HYDROCHLORIDE
esmolol hydrochloride	ESMOLOL HYDROCHLORIDE	Sagent Pharmaceuticals	f12fb0fd-fa05-49fc-b5e3-a2050b816ef2	2023-07-12	Warnings, Adverse reactions	Name fallback brand name: esmolol hydrochloride generic name: ESMOLOL HYDROCHLORIDE
Esmolol Hydrochloride	ESMOLOL HYDROCHLORIDE	Gland Pharma Limited	017023a9-00f0-4284-861f-a3634d4fdb17	2023-06-23	Warnings, Adverse reactions	Name fallback brand name: Esmolol Hydrochloride generic name: ESMOLOL HYDROCHLORIDE
Esmolol Hydrochloride	ESMOLOL HYDROCHLORIDE	Baxter Healthcare Corporation	f0a56c07-8f0f-4499-8d00-f13a966bf988	2023-06-15	Warnings, Adverse reactions	Name fallback brand name: Esmolol Hydrochloride generic name: ESMOLOL HYDROCHLORIDE
Esmolol Hydrochloride	ESMOLOL HYDROCHLORIDE	Medical Purchasing Solutions, LLC	6bb9921c-a0f9-309f-e053-2a91aa0a1e5e	2023-05-30	Warnings, Adverse reactions	Name fallback brand name: Esmolol Hydrochloride generic name: ESMOLOL HYDROCHLORIDE
Esmolol Hydrochloride	ESMOLOL HYDROCHLORIDE	Medical Purchasing Solutions, LLC	6bdd5315-75ce-1537-e053-2991aa0a6549	2023-05-22	Warnings, Adverse reactions	Name fallback brand name: Esmolol Hydrochloride generic name: ESMOLOL HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
44567-450	Esmolol Hydrochloride	Esmolol Hydrochloride	WG Critical Care, LLC	ANDA	Current
44567-451	Esmolol Hydrochloride	Esmolol Hydrochloride	WG Critical Care, LLC	ANDA	Current