BREVIBLOC

Product NDC
10019-672
11-digit product format
100190672
Labeler code
10019
Product ID
10019-672_d42ec921-e5eb-4a54-b420-234812c2c2a8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
esmolol hydrochloride
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Baxter Healthcare Corporation
Application
NDA019386
Marketing category
NDA
Marketing start
1986-12-31
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N019386-003BREVIBLOCESMOLOL HYDROCHLORIDE10MG/MLINJECTABLE / INJECTION1988-08-15
N019386-004BREVIBLOC IN PLASTIC CONTAINERESMOLOL HYDROCHLORIDE1GM/100MLINJECTABLE / INJECTIONAPRLD, RS2001-02-16
N019386-005BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINERESMOLOL HYDROCHLORIDE2GM/100MLINJECTABLE / INJECTIONAPRLD, RS2003-01-27
N019386-006BREVIBLOCESMOLOL HYDROCHLORIDE10MG/MLINJECTABLE / INJECTIONAPRLD, RS2003-02-25
N019386-007BREVIBLOCESMOLOL HYDROCHLORIDE20MG/MLINJECTABLE / INJECTION2003-05-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N019386-004AP
N019386-005AP
N019386-006AP

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N019386-003BREVIBLOC10MG/MLINJECTABLE / INJECTION1988-08-15caaa826d4ba7…
2026-08-18 06:07:402026-07N019386-004BREVIBLOC IN PLASTIC CONTAINER1GM/100MLINJECTABLE / INJECTIONAPRLD, RS2001-02-16caaa826d4ba7…
2026-08-18 06:07:402026-07N019386-005BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER2GM/100MLINJECTABLE / INJECTIONAPRLD, RS2003-01-27caaa826d4ba7…
2026-08-18 06:07:402026-07N019386-006BREVIBLOC10MG/MLINJECTABLE / INJECTIONAPRLD, RS2003-02-25caaa826d4ba7…
2026-08-18 06:07:402026-07N019386-007BREVIBLOC20MG/MLINJECTABLE / INJECTION2003-05-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N019386-003BREVIBLOC10MG/MLINJECTABLE / INJECTION1988-08-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019386-004BREVIBLOC IN PLASTIC CONTAINER1GM/100MLINJECTABLE / INJECTIONAPRLD, RS2001-02-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019386-005BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER2GM/100MLINJECTABLE / INJECTIONAPRLD, RS2003-01-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019386-006BREVIBLOC10MG/MLINJECTABLE / INJECTIONAPRLD, RS2003-02-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019386-007BREVIBLOC20MG/MLINJECTABLE / INJECTION2003-05-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019386-003BREVIBLOC10MG/MLINJECTABLE / INJECTION1988-08-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019386-004BREVIBLOC IN PLASTIC CONTAINER1GM/100MLINJECTABLE / INJECTIONAPRLD, RS2001-02-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019386-005BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER2GM/100MLINJECTABLE / INJECTIONAPRLD, RS2003-01-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019386-006BREVIBLOC10MG/MLINJECTABLE / INJECTIONAPRLD, RS2003-02-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019386-007BREVIBLOC20MG/MLINJECTABLE / INJECTION2003-05-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08N019386-003BREVIBLOC10MG/MLINJECTABLE / INJECTION1988-08-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019386-004BREVIBLOC IN PLASTIC CONTAINER1GM/100MLINJECTABLE / INJECTIONAPRLD, RS2001-02-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019386-005BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER2GM/100MLINJECTABLE / INJECTIONAPRLD, RS2003-01-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019386-006BREVIBLOC10MG/MLINJECTABLE / INJECTIONAPRLD, RS2003-02-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019386-007BREVIBLOC20MG/MLINJECTABLE / INJECTION2003-05-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019386-003BREVIBLOC10MG/MLINJECTABLE / INJECTION1988-08-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019386-004BREVIBLOC IN PLASTIC CONTAINER1GM/100MLINJECTABLE / INJECTIONAPRLD, RS2001-02-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019386-005BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER2GM/100MLINJECTABLE / INJECTIONAPRLD, RS2003-01-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019386-006BREVIBLOC10MG/MLINJECTABLE / INJECTIONAPRLD, RS2003-02-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019386-007BREVIBLOC20MG/MLINJECTABLE / INJECTION2003-05-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019386-003BREVIBLOC10MG/MLINJECTABLE / INJECTION1988-08-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019386-004BREVIBLOC IN PLASTIC CONTAINER1GM/100MLINJECTABLE / INJECTIONAPRLD, RS2001-02-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019386-005BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER2GM/100MLINJECTABLE / INJECTIONAPRLD, RS2003-01-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019386-006BREVIBLOC10MG/MLINJECTABLE / INJECTIONAPRLD, RS2003-02-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019386-007BREVIBLOC20MG/MLINJECTABLE / INJECTION2003-05-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019386-003BREVIBLOC10MG/MLINJECTABLE / INJECTION1988-08-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019386-004BREVIBLOC IN PLASTIC CONTAINER1GM/100MLINJECTABLE / INJECTIONAPRLD, RS2001-02-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019386-005BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER2GM/100MLINJECTABLE / INJECTIONAPRLD, RS2003-01-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019386-006BREVIBLOC10MG/MLINJECTABLE / INJECTIONAPRLD, RS2003-02-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019386-007BREVIBLOC20MG/MLINJECTABLE / INJECTION2003-05-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019386-003BREVIBLOC10MG/MLINJECTABLE / INJECTION1988-08-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019386-004BREVIBLOC IN PLASTIC CONTAINER1GM/100MLINJECTABLE / INJECTIONAPRLD, RS2001-02-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019386-005BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER2GM/100MLINJECTABLE / INJECTIONAPRLD, RS2003-01-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019386-006BREVIBLOC10MG/MLINJECTABLE / INJECTIONAPRLD, RS2003-02-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019386-007BREVIBLOC20MG/MLINJECTABLE / INJECTION2003-05-282680178bc6a6…

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07N019386-004AP1caaa826d4ba7…
2026-08-18 06:07:402026-07N019386-005AP1caaa826d4ba7…
2026-08-18 06:07:402026-07N019386-006AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N019386-004AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019386-005AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019386-006AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019386-004AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019386-005AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019386-006AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08N019386-004AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019386-005AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019386-006AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019386-004AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019386-005AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019386-006AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019386-004AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019386-005AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019386-006AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019386-004AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019386-005AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019386-006AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019386-004AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019386-005AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019386-006AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019386-004AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019386-005AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019386-006AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019386-004AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019386-005AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019386-006AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N019386-004AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10N019386-005AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10N019386-006AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019386-004AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019386-005AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019386-006AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019386-004AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019386-005AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019386-006AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019386-004AP11e350fbaab3a…

Observed Orange Book patent history#

Patent history page 1 of 4 · 144 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2019-12-13 00:20 UTC2019-12N019386-00463100942021-01-1274a2ff9319b5…
2019-12-13 00:20 UTC2019-12N019386-00465285402021-01-1274a2ff9319b5…
2019-12-13 00:20 UTC2019-12N019386-0046310094*PED2021-07-12Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N019386-0046528540*PED2021-07-12Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N019386-00563100942021-01-1274a2ff9319b5…
2019-12-13 00:20 UTC2019-12N019386-00565285402021-01-1274a2ff9319b5…
2019-12-13 00:20 UTC2019-12N019386-0056310094*PED2021-07-12Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N019386-0056528540*PED2021-07-12Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N019386-00663100942021-01-1274a2ff9319b5…
2019-12-13 00:20 UTC2019-12N019386-00665285402021-01-1274a2ff9319b5…
2019-12-13 00:20 UTC2019-12N019386-0066310094*PED2021-07-12Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N019386-0066528540*PED2021-07-12Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N019386-00763100942021-01-1274a2ff9319b5…
2019-12-13 00:20 UTC2019-12N019386-00765285402021-01-1274a2ff9319b5…
2019-12-13 00:20 UTC2019-12N019386-0076310094*PED2021-07-12Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N019386-0076528540*PED2021-07-12Pediatric extension74a2ff9319b5…
2021-12-28 21:50 UTC2021-12N019386-00463100942021-01-12782e0a99824c…
2021-12-28 21:50 UTC2021-12N019386-00465285402021-01-12782e0a99824c…
2021-12-28 21:50 UTC2021-12N019386-0046310094*PED2021-07-12Pediatric extension782e0a99824c…
2021-12-28 21:50 UTC2021-12N019386-0046528540*PED2021-07-12Pediatric extension782e0a99824c…
2021-12-28 21:50 UTC2021-12N019386-00563100942021-01-12782e0a99824c…
2021-12-28 21:50 UTC2021-12N019386-00565285402021-01-12782e0a99824c…
2021-12-28 21:50 UTC2021-12N019386-0056310094*PED2021-07-12Pediatric extension782e0a99824c…
2021-12-28 21:50 UTC2021-12N019386-0056528540*PED2021-07-12Pediatric extension782e0a99824c…
2021-12-28 21:50 UTC2021-12N019386-00663100942021-01-12782e0a99824c…
2021-12-28 21:50 UTC2021-12N019386-00665285402021-01-12782e0a99824c…
2021-12-28 21:50 UTC2021-12N019386-0066310094*PED2021-07-12Pediatric extension782e0a99824c…
2021-12-28 21:50 UTC2021-12N019386-0066528540*PED2021-07-12Pediatric extension782e0a99824c…
2021-12-28 21:50 UTC2021-12N019386-00763100942021-01-12782e0a99824c…
2021-12-28 21:50 UTC2021-12N019386-00765285402021-01-12782e0a99824c…
2021-12-28 21:50 UTC2021-12N019386-0076310094*PED2021-07-12Pediatric extension782e0a99824c…
2021-12-28 21:50 UTC2021-12N019386-0076528540*PED2021-07-12Pediatric extension782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N019386-00463100942021-01-1287673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N019386-00465285402021-01-1287673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N019386-0046310094*PED2021-07-12Pediatric extension87673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N019386-0046528540*PED2021-07-12Pediatric extension87673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N019386-00563100942021-01-1287673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N019386-00565285402021-01-1287673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N019386-0056310094*PED2021-07-12Pediatric extension87673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N019386-0056528540*PED2021-07-12Pediatric extension87673890dc5c…

Additional Listing Data#

Finished product
Yes
Brand name base
BREVIBLOC
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ESMOLOL HYDROCHLORIDE10 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
V05260LC8DInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
979432Internal RxNorm lookup
979434Internal RxNorm lookup
1736541Internal RxNorm lookup
1736543Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
220a07b8-5c68-41a3-8705-fd91f14c50b4Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
ab3d10ea-fe48-4811-8e72-bb51600b35f9Product name520230103
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
9cb9173b-3912-466b-8256-366e71d49fceProduct name120190402
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10019-672-10BREVIBLOC250 mL in 1 BAGINJECTION25015
10019-672-10BREVIBLOC10 in 1 CARTONINJECTION1015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10019-672-10ML - Milliliter10019-672b2111608-4716-478f-b73b-b77671af023712018-06-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10019-672BREVIBLOC (ESMOLOL HYDROCHLORIDE) INJECTION [BAXTER HEALTHCARE CORPORATION]13Current NDC, Legacy NDC, 2 package rows20250328_220a07b8-5c68-41a3-8705-fd91f14c50b4.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BreviblocESMOLOL HYDROCHLORIDEHenry Schein, Inc38a8b23a-fca8-45f4-a09a-9c8b21f522cd2025-10-27Warnings, Adverse reactionsExact identifier
application applno (NDA): 019386
application number: NDA019386
BREVIBLOCESMOLOL HYDROCHLORIDEBaxter Healthcare Company220a07b8-5c68-41a3-8705-fd91f14c50b42025-03-14Warnings, Adverse reactionsExact identifier
application applno (NDA): 019386
application number: NDA019386
ndc (product): 10019-672
BREVIBLOCESMOLOL HYDROCHLORIDEBaxter Healthcare Company9c593cdb-cdfe-4492-8862-9b05116aa25e2025-03-14Warnings, Adverse reactionsExact identifier
application applno (NDA): 019386
application number: NDA019386
BreviblocESMOLOL HYDROCHLORIDEBaxter Healthcare Company595cc3d5-1306-4828-aefa-5595219ffd622025-03-14Warnings, Adverse reactionsExact identifier
application applno (NDA): 019386
application number: NDA019386
ESMOLOL HYDROCHLORIDEESMOLOL HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirst9a3e69ab-3ffe-33af-e053-2a95a90a65242025-01-08Warnings, Adverse reactionsExact identifier
application applno (NDA): 019386
application number: NDA019386
Esmolol HydrochlorideESMOLOL HYDROCHLORIDEBaxter Healthcare Corporationf0a56c07-8f0f-4499-8d00-f13a966bf9882023-06-15Warnings, Adverse reactionsExact identifier
application applno (NDA): 019386
application number: NDA019386
Esmolol HydrochlorideESMOLOL HYDROCHLORIDEMedical Purchasing Solutions, LLC6bdd5315-75ce-1537-e053-2991aa0a65492023-05-22Warnings, Adverse reactionsExact identifier
application applno (NDA): 019386
application number: NDA019386

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979434Brevibloc 2000 MG in 100 ML InjectionPSN220a07b8-5c68-41a3-8705-fd91f14c50b415
1736543Brevibloc 2500 MG in 250 ML InjectionPSN220a07b8-5c68-41a3-8705-fd91f14c50b415
979432esmolol HCl 2000 MG in 100 ML InjectionPSN220a07b8-5c68-41a3-8705-fd91f14c50b415
1736541esmolol HCl 2500 MG in 250 ML InjectionPSN220a07b8-5c68-41a3-8705-fd91f14c50b415
979434100 ML esmolol hydrochloride 20 MG/ML Injection [Brevibloc]SBD220a07b8-5c68-41a3-8705-fd91f14c50b415
1736543250 ML esmolol hydrochloride 10 MG/ML Injection [Brevibloc]SBD220a07b8-5c68-41a3-8705-fd91f14c50b415
979432100 ML esmolol hydrochloride 20 MG/ML InjectionSCD220a07b8-5c68-41a3-8705-fd91f14c50b415
1736541250 ML esmolol hydrochloride 10 MG/ML InjectionSCD220a07b8-5c68-41a3-8705-fd91f14c50b415
979434100 ML Brevibloc 20 MG/ML InjectionSY220a07b8-5c68-41a3-8705-fd91f14c50b415
1736543250 ML Brevibloc 10 MG/ML InjectionSY220a07b8-5c68-41a3-8705-fd91f14c50b415
979434Brevibloc 2000 MG per 100 ML InjectionSY220a07b8-5c68-41a3-8705-fd91f14c50b415
1736543Brevibloc 2500 MG per 250 ML InjectionSY220a07b8-5c68-41a3-8705-fd91f14c50b415
979432esmolol HCl 2000 MG per 100 ML InjectionSY220a07b8-5c68-41a3-8705-fd91f14c50b415
1736541esmolol HCl 2500 MG per 250 ML InjectionSY220a07b8-5c68-41a3-8705-fd91f14c50b415

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10019-672-101001906721010 BAG in 1 CARTON (10019-672-10) / 250 mL in 1 BAG10 bag2018-01-310000-00-00NoNoCurrent