FDA.reportPublic FDA data

Brevibloc

Product NDC
10019-075
11-digit product format
100190075
Labeler code
10019
Product ID
10019-075_ff209fbb-f087-4772-8945-9b1ab9a8c3a2
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, 1736546, 1736547

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
10019-075-87Brevibloc100 mL in 1 BAGINJECTION10029
10019-075-87Brevibloc10 in 1 CARTONINJECTION1029

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10019-075-87ML - Milliliter10019-0754bea5174-e1f5-4f16-aaf1-82cfcbc9141c12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ESMOLOL HYDROCHLORIDEACTIVE INGREDIENTV05260LC8DBREVIBLOC (ESMOLOL HYDROCHLORIDE) INJECTION [BAXTER HEALTHCARE CORPORATION]7
ESMOLOLACTIVE MOIETYMDY902UXSRBREVIBLOC (ESMOLOL HYDROCHLORIDE) INJECTION [BAXTER HEALTHCARE CORPORATION]7
ACETIC ACIDINACTIVE INGREDIENTQ40Q9N063PBREVIBLOC (ESMOLOL HYDROCHLORIDE) INJECTION [BAXTER HEALTHCARE CORPORATION]7
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBBREVIBLOC (ESMOLOL HYDROCHLORIDE) INJECTION [BAXTER HEALTHCARE CORPORATION]7
SODIUM ACETATEINACTIVE INGREDIENT4550K0SC9BBREVIBLOC (ESMOLOL HYDROCHLORIDE) INJECTION [BAXTER HEALTHCARE CORPORATION]7
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XBREVIBLOC (ESMOLOL HYDROCHLORIDE) INJECTION [BAXTER HEALTHCARE CORPORATION]7
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IBREVIBLOC (ESMOLOL HYDROCHLORIDE) INJECTION [BAXTER HEALTHCARE CORPORATION]7
WATERINACTIVE INGREDIENT059QF0KO0RBREVIBLOC (ESMOLOL HYDROCHLORIDE) INJECTION [BAXTER HEALTHCARE CORPORATION]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10019-075BREVIBLOC (ESMOLOL HYDROCHLORIDE) INJECTION [BAXTER HEALTHCARE CORPORATION]27Current NDC, Legacy NDC, 2 package rows20250322_595cc3d5-1306-4828-aefa-5595219ffd62.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1736547Brevibloc 100 MG in 10 ML InjectionPSN595cc3d5-1306-4828-aefa-5595219ffd6229
979434Brevibloc 2000 MG in 100 ML InjectionPSN595cc3d5-1306-4828-aefa-5595219ffd6229
1736543Brevibloc 2500 MG in 250 ML InjectionPSN595cc3d5-1306-4828-aefa-5595219ffd6229
1736546esmolol HCl 100 MG in 10 ML InjectionPSN595cc3d5-1306-4828-aefa-5595219ffd6229
979432esmolol HCl 2000 MG in 100 ML InjectionPSN595cc3d5-1306-4828-aefa-5595219ffd6229
1736541esmolol HCl 2500 MG in 250 ML InjectionPSN595cc3d5-1306-4828-aefa-5595219ffd6229
173654710 ML esmolol hydrochloride 10 MG/ML Injection [Brevibloc]SBD595cc3d5-1306-4828-aefa-5595219ffd6229
979434100 ML esmolol hydrochloride 20 MG/ML Injection [Brevibloc]SBD595cc3d5-1306-4828-aefa-5595219ffd6229
1736543250 ML esmolol hydrochloride 10 MG/ML Injection [Brevibloc]SBD595cc3d5-1306-4828-aefa-5595219ffd6229
173654610 ML esmolol hydrochloride 10 MG/ML InjectionSCD595cc3d5-1306-4828-aefa-5595219ffd6229
979432100 ML esmolol hydrochloride 20 MG/ML InjectionSCD595cc3d5-1306-4828-aefa-5595219ffd6229
1736541250 ML esmolol hydrochloride 10 MG/ML InjectionSCD595cc3d5-1306-4828-aefa-5595219ffd6229
173654710 ML Brevibloc 10 MG/ML InjectionSY595cc3d5-1306-4828-aefa-5595219ffd6229
979434100 ML Brevibloc 20 MG/ML InjectionSY595cc3d5-1306-4828-aefa-5595219ffd6229
1736543250 ML Brevibloc 10 MG/ML InjectionSY595cc3d5-1306-4828-aefa-5595219ffd6229
1736547Brevibloc 100 MG per 10 ML InjectionSY595cc3d5-1306-4828-aefa-5595219ffd6229
979434Brevibloc 2000 MG per 100 ML InjectionSY595cc3d5-1306-4828-aefa-5595219ffd6229
1736543Brevibloc 2500 MG per 250 ML InjectionSY595cc3d5-1306-4828-aefa-5595219ffd6229
1736546esmolol HCl 100 MG per 10 ML InjectionSY595cc3d5-1306-4828-aefa-5595219ffd6229
979432esmolol HCl 2000 MG per 100 ML InjectionSY595cc3d5-1306-4828-aefa-5595219ffd6229
1736541esmolol HCl 2500 MG per 250 ML InjectionSY595cc3d5-1306-4828-aefa-5595219ffd6229

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10019-075-871001900758710 BAG in 1 CARTON (10019-075-87) / 100 mL in 1 BAG10 bag1986-12-310000-00-00NoNoCurrent