Esmolol

Product NDC: 52584-017
11-digit product format: 525840017
Labeler code: 52584
Product ID: 52584-017_53bd9a5c-596a-4692-a48e-676f5f8d8657
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Esmolol
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: General Injectables & Vaccines, Inc
Application: NDA019386
Marketing category: NDA
Marketing start: 2010-04-01
Marketing end: 0000-00-00
Substance: ESMOLOL HYDROCHLORIDE
Active strength: 10 mg/mL
Pharmacologic classes: Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
NDC exclude flag: E
Listing certified through: 2018-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	52584-017		I	Inactivated by FDA		2026-08-17
excluded package	package	52584-017	52584-017-41	D	Discontinued by firm		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 34 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52584-017-41	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52584-017-41	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52584-017-41	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52584-017-41	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52584-017-41	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52584-017-41	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	52584-017-41	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	52584-017-41	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	52584-017-41	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	52584-017-41	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	52584-017-41	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	52584-017-41	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N019386-003	BREVIBLOC	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION			1988-08-15
N019386-004	BREVIBLOC IN PLASTIC CONTAINER	ESMOLOL HYDROCHLORIDE	1GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	2001-02-16
N019386-005	BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER	ESMOLOL HYDROCHLORIDE	2GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	2003-01-27
N019386-006	BREVIBLOC	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2003-02-25
N019386-007	BREVIBLOC	ESMOLOL HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION			2003-05-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
N019386-004	AP
N019386-005	AP
N019386-006	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 6 · 210 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	N019386-003	BREVIBLOC	10MG/ML	INJECTABLE / INJECTION			1988-08-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019386-004	BREVIBLOC IN PLASTIC CONTAINER	1GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	2001-02-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019386-005	BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER	2GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	2003-01-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019386-006	BREVIBLOC	10MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2003-02-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019386-007	BREVIBLOC	20MG/ML	INJECTABLE / INJECTION			2003-05-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019386-003	BREVIBLOC	10MG/ML	INJECTABLE / INJECTION			1988-08-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019386-004	BREVIBLOC IN PLASTIC CONTAINER	1GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	2001-02-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019386-005	BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER	2GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	2003-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019386-006	BREVIBLOC	10MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2003-02-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019386-007	BREVIBLOC	20MG/ML	INJECTABLE / INJECTION			2003-05-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019386-003	BREVIBLOC	10MG/ML	INJECTABLE / INJECTION			1988-08-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019386-004	BREVIBLOC IN PLASTIC CONTAINER	1GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	2001-02-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019386-005	BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER	2GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	2003-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019386-006	BREVIBLOC	10MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2003-02-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019386-007	BREVIBLOC	20MG/ML	INJECTABLE / INJECTION			2003-05-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019386-003	BREVIBLOC	10MG/ML	INJECTABLE / INJECTION			1988-08-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019386-004	BREVIBLOC IN PLASTIC CONTAINER	1GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	2001-02-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019386-005	BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER	2GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	2003-01-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019386-006	BREVIBLOC	10MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2003-02-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019386-007	BREVIBLOC	20MG/ML	INJECTABLE / INJECTION			2003-05-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019386-003	BREVIBLOC	10MG/ML	INJECTABLE / INJECTION			1988-08-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019386-004	BREVIBLOC IN PLASTIC CONTAINER	1GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	2001-02-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019386-005	BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER	2GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	2003-01-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019386-006	BREVIBLOC	10MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2003-02-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019386-007	BREVIBLOC	20MG/ML	INJECTABLE / INJECTION			2003-05-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019386-003	BREVIBLOC	10MG/ML	INJECTABLE / INJECTION			1988-08-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019386-004	BREVIBLOC IN PLASTIC CONTAINER	1GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	2001-02-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019386-005	BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER	2GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	2003-01-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019386-006	BREVIBLOC	10MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2003-02-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019386-007	BREVIBLOC	20MG/ML	INJECTABLE / INJECTION			2003-05-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019386-003	BREVIBLOC	10MG/ML	INJECTABLE / INJECTION			1988-08-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019386-004	BREVIBLOC IN PLASTIC CONTAINER	1GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	2001-02-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019386-005	BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER	2GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	2003-01-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019386-006	BREVIBLOC	10MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2003-02-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019386-007	BREVIBLOC	20MG/ML	INJECTABLE / INJECTION			2003-05-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019386-003	BREVIBLOC	10MG/ML	INJECTABLE / INJECTION			1988-08-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019386-004	BREVIBLOC IN PLASTIC CONTAINER	1GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	2001-02-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019386-005	BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER	2GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	2003-01-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019386-006	BREVIBLOC	10MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2003-02-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019386-007	BREVIBLOC	20MG/ML	INJECTABLE / INJECTION			2003-05-28	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 90 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N019386-004	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019386-005	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019386-006	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019386-004	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019386-005	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019386-006	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019386-004	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019386-005	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019386-006	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019386-004	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019386-005	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019386-006	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019386-004	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019386-005	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019386-006	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019386-004	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019386-005	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019386-006	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019386-004	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019386-005	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019386-006	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019386-004	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019386-005	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019386-006	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019386-004	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019386-005	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019386-006	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019386-004	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019386-005	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019386-006	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019386-004	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019386-005	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019386-006	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019386-004	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019386-005	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019386-006	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019386-004	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019386-005	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019386-006	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019386-004	AP	1	`1e350fbaab3a…`

Observed Orange Book patent history#

Patent history page 1 of 4 · 144 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N019386-004	6310094	2021-01-12		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019386-004	6528540	2021-01-12		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019386-004	6310094*PED	2021-07-12	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019386-004	6528540*PED	2021-07-12	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019386-005	6310094	2021-01-12		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019386-005	6528540	2021-01-12		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019386-005	6310094*PED	2021-07-12	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019386-005	6528540*PED	2021-07-12	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019386-006	6310094	2021-01-12		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019386-006	6528540	2021-01-12		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019386-006	6310094*PED	2021-07-12	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019386-006	6528540*PED	2021-07-12	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019386-007	6310094	2021-01-12		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019386-007	6528540	2021-01-12		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019386-007	6310094*PED	2021-07-12	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019386-007	6528540*PED	2021-07-12	Pediatric extension	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N019386-004	6310094	2021-01-12		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N019386-004	6528540	2021-01-12		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N019386-004	6310094*PED	2021-07-12	Pediatric extension	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N019386-004	6528540*PED	2021-07-12	Pediatric extension	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N019386-005	6310094	2021-01-12		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N019386-005	6528540	2021-01-12		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N019386-005	6310094*PED	2021-07-12	Pediatric extension	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N019386-005	6528540*PED	2021-07-12	Pediatric extension	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N019386-006	6310094	2021-01-12		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N019386-006	6528540	2021-01-12		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N019386-006	6310094*PED	2021-07-12	Pediatric extension	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N019386-006	6528540*PED	2021-07-12	Pediatric extension	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N019386-007	6310094	2021-01-12		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N019386-007	6528540	2021-01-12		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N019386-007	6310094*PED	2021-07-12	Pediatric extension	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N019386-007	6528540*PED	2021-07-12	Pediatric extension	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019386-004	6310094	2021-01-12		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019386-004	6528540	2021-01-12		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019386-004	6310094*PED	2021-07-12	Pediatric extension	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019386-004	6528540*PED	2021-07-12	Pediatric extension	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019386-005	6310094	2021-01-12		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019386-005	6528540	2021-01-12		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019386-005	6310094*PED	2021-07-12	Pediatric extension	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019386-005	6528540*PED	2021-07-12	Pediatric extension	`87673890dc5c…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ab3d10ea-fe48-4811-8e72-bb51600b35f9	Product name	5	20230103
9cb9173b-3912-466b-8256-366e71d49fce	Product name	1	20190402

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
52584-017-41	2020-01-31	C162847	48780-1	9d75b9d0-6ff1-f424-e053-dadaa90a57ce	Esmolol HCL 10 mg/mL Injection 10mL Single Dose Vial

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
52584-017-41	Esmolol	1 in 1 BAG	INJECTION	1		3
52584-017-41	Esmolol	10 mL in 1 VIAL, SINGLE-DOSE	INJECTION	10		3

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
Esmolol Hydrochloride	ACTIVE INGREDIENT	V05260LC8D	ESMOLOL INJECTION [GENERAL INJECTABLES & VACCINES, INC]	2
Esmolol	ACTIVE MOIETY	MDY902UXSR	ESMOLOL INJECTION [GENERAL INJECTABLES & VACCINES, INC]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52584-017	ESMOLOL INJECTION [GENERAL INJECTABLES & VACCINES, INC]	3	Legacy NDC, 2 package rows	20170119_35460df2-18d3-4132-85e6-5289bad4c670.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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Brevibloc	ESMOLOL HYDROCHLORIDE	Henry Schein, Inc	38a8b23a-fca8-45f4-a09a-9c8b21f522cd	2025-10-27	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019386 application number: NDA019386
BREVIBLOC	ESMOLOL HYDROCHLORIDE	Baxter Healthcare Company	220a07b8-5c68-41a3-8705-fd91f14c50b4	2025-03-14	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019386 application number: NDA019386
BREVIBLOC	ESMOLOL HYDROCHLORIDE	Baxter Healthcare Company	9c593cdb-cdfe-4492-8862-9b05116aa25e	2025-03-14	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019386 application number: NDA019386
Brevibloc	ESMOLOL HYDROCHLORIDE	Baxter Healthcare Company	595cc3d5-1306-4828-aefa-5595219ffd62	2025-03-14	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019386 application number: NDA019386
ESMOLOL HYDROCHLORIDE	ESMOLOL HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	9a3e69ab-3ffe-33af-e053-2a95a90a6524	2025-01-08	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019386 application number: NDA019386
Esmolol Hydrochloride	ESMOLOL HYDROCHLORIDE	Baxter Healthcare Corporation	f0a56c07-8f0f-4499-8d00-f13a966bf988	2023-06-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019386 application number: NDA019386
Esmolol Hydrochloride	ESMOLOL HYDROCHLORIDE	Medical Purchasing Solutions, LLC	6bdd5315-75ce-1537-e053-2991aa0a6549	2023-05-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019386 application number: NDA019386

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
V05260LC8D	ESMOLOL HYDROCHLORIDE	81161-17-3	ESMOLOL HYDROCHLORIDE
MDY902UXSR	ESMOLOL	81147-92-4	Esmolol

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1736546	esmolol HCl 100 MG in 10 ML Injection	PSN	35460df2-18d3-4132-85e6-5289bad4c670	3
1736546	10 ML esmolol hydrochloride 10 MG/ML Injection	SCD	35460df2-18d3-4132-85e6-5289bad4c670	3
1736546	esmolol HCl 100 MG per 10 ML Injection	SY	35460df2-18d3-4132-85e6-5289bad4c670	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
52584-017-41	52584001741	1 in 1 BAG	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Esmolol HCL 10 mg/mL Injection 10mL Single Dose Vial	General Injectables & Vaccines, Inc	2017-01-18	HUMAN PRESCRIPTION DRUG LABEL	3