FDA.reportPublic FDA data

BREVIBLOC

Product NDC
10019-666
11-digit product format
100190666
Labeler code
10019
Product ID
10019-666_2172ae57-a40f-42c5-9f3a-c94a346d24eb
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
20 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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ESMOLOL HYDROCHLORIDE20 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV05260LC8D
Rxcui979432, 979434, 1736541, 1736543

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
ab3d10ea-fe48-4811-8e72-bb51600b35f9Product name520230103
9cb9173b-3912-466b-8256-366e71d49fceProduct name120190402
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10019-666-10BREVIBLOC100 mL in 1 BAGINJECTION10014
10019-666-10BREVIBLOC10 in 1 CARTONINJECTION1014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10019-666-10ML - Milliliter10019-666713cb736-b0be-4b41-8ec2-6aa8a6677c3612018-06-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10019-666BREVIBLOC (ESMOLOL HYDROCHLORIDE) INJECTION [BAXTER HEALTHCARE CORPORATION]12Current NDC, Legacy NDC, 2 package rows20250328_9c593cdb-cdfe-4492-8862-9b05116aa25e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979434Brevibloc 2000 MG in 100 ML InjectionPSN9c593cdb-cdfe-4492-8862-9b05116aa25e14
1736543Brevibloc 2500 MG in 250 ML InjectionPSN9c593cdb-cdfe-4492-8862-9b05116aa25e14
979432esmolol HCl 2000 MG in 100 ML InjectionPSN9c593cdb-cdfe-4492-8862-9b05116aa25e14
1736541esmolol HCl 2500 MG in 250 ML InjectionPSN9c593cdb-cdfe-4492-8862-9b05116aa25e14
979434100 ML esmolol hydrochloride 20 MG/ML Injection [Brevibloc]SBD9c593cdb-cdfe-4492-8862-9b05116aa25e14
1736543250 ML esmolol hydrochloride 10 MG/ML Injection [Brevibloc]SBD9c593cdb-cdfe-4492-8862-9b05116aa25e14
979432100 ML esmolol hydrochloride 20 MG/ML InjectionSCD9c593cdb-cdfe-4492-8862-9b05116aa25e14
1736541250 ML esmolol hydrochloride 10 MG/ML InjectionSCD9c593cdb-cdfe-4492-8862-9b05116aa25e14
979434100 ML Brevibloc 20 MG/ML InjectionSY9c593cdb-cdfe-4492-8862-9b05116aa25e14
1736543250 ML Brevibloc 10 MG/ML InjectionSY9c593cdb-cdfe-4492-8862-9b05116aa25e14
979434Brevibloc 2000 MG per 100 ML InjectionSY9c593cdb-cdfe-4492-8862-9b05116aa25e14
1736543Brevibloc 2500 MG per 250 ML InjectionSY9c593cdb-cdfe-4492-8862-9b05116aa25e14
979432esmolol HCl 2000 MG per 100 ML InjectionSY9c593cdb-cdfe-4492-8862-9b05116aa25e14
1736541esmolol HCl 2500 MG per 250 ML InjectionSY9c593cdb-cdfe-4492-8862-9b05116aa25e14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10019-666-101001906661010 BAG in 1 CARTON (10019-666-10) / 100 mL in 1 BAG10 bag2017-11-010000-00-00NoNoCurrent