Brevibloc

Product NDC: 0404-9825
11-digit product format: 004049825
Labeler code: 0404
Product ID: 0404-9825_a2e6fea4-a597-45d7-b157-0b67c924f1bf
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: esmolol hydrochloride
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: Henry Schein, Inc
Application: NDA019386
Marketing category: NDA
Marketing start: 2022-01-09
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 · 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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Brevibloc
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
1736546	Internal RxNorm lookup
1736547	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
38a8b23a-fca8-45f4-a09a-9c8b21f522cd	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0404-9825-10	Brevibloc	1 in 1 BAG	INJECTION	1		6
0404-9825-10	Brevibloc	10 mL in 1 VIAL, SINGLE-DOSE	INJECTION	10		6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0404-9825	BREVIBLOC (ESMOLOL HYDROCHLORIDE) INJECTION [HENRY SCHEIN, INC]	5	Current NDC, Legacy NDC, 2 package rows	20241016_38a8b23a-fca8-45f4-a09a-9c8b21f522cd.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 ndc (product): 0404-9825
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1736547	Brevibloc 100 MG in 10 ML Injection	PSN	38a8b23a-fca8-45f4-a09a-9c8b21f522cd	6
1736546	esmolol HCl 100 MG in 10 ML Injection	PSN	38a8b23a-fca8-45f4-a09a-9c8b21f522cd	6
1736547	10 ML esmolol hydrochloride 10 MG/ML Injection [Brevibloc]	SBD	38a8b23a-fca8-45f4-a09a-9c8b21f522cd	6
1736546	10 ML esmolol hydrochloride 10 MG/ML Injection	SCD	38a8b23a-fca8-45f4-a09a-9c8b21f522cd	6
1736547	10 ML Brevibloc 10 MG/ML Injection	SY	38a8b23a-fca8-45f4-a09a-9c8b21f522cd	6
1736547	Brevibloc 100 MG per 10 ML Injection	SY	38a8b23a-fca8-45f4-a09a-9c8b21f522cd	6
1736546	esmolol HCl 100 MG per 10 ML Injection	SY	38a8b23a-fca8-45f4-a09a-9c8b21f522cd	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0404-9825-10	00404982510	1 VIAL, SINGLE-DOSE in 1 BAG (0404-9825-10) / 10 mL in 1 VIAL, SINGLE-DOSE	2022-01-09	0000-00-00	No	No	Current