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

Additional Listing Data#

Finished product
Yes
Brand name base
Brevibloc
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ESMOLOL HYDROCHLORIDE10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV05260LC8D
Rxcui1736546, 1736547

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ab3d10ea-fe48-4811-8e72-bb51600b35f9Product name520230103
9cb9173b-3912-466b-8256-366e71d49fceProduct name120190402

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0404-9825-10Brevibloc1 in 1 BAGINJECTION16
0404-9825-10Brevibloc10 mL in 1 VIAL, SINGLE-DOSEINJECTION106

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0404-9825BREVIBLOC (ESMOLOL HYDROCHLORIDE) INJECTION [HENRY SCHEIN, INC]5Current NDC, Legacy NDC, 2 package rows20241016_38a8b23a-fca8-45f4-a09a-9c8b21f522cd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1736547Brevibloc 100 MG in 10 ML InjectionPSN38a8b23a-fca8-45f4-a09a-9c8b21f522cd6
1736546esmolol HCl 100 MG in 10 ML InjectionPSN38a8b23a-fca8-45f4-a09a-9c8b21f522cd6
173654710 ML esmolol hydrochloride 10 MG/ML Injection [Brevibloc]SBD38a8b23a-fca8-45f4-a09a-9c8b21f522cd6
173654610 ML esmolol hydrochloride 10 MG/ML InjectionSCD38a8b23a-fca8-45f4-a09a-9c8b21f522cd6
173654710 ML Brevibloc 10 MG/ML InjectionSY38a8b23a-fca8-45f4-a09a-9c8b21f522cd6
1736547Brevibloc 100 MG per 10 ML InjectionSY38a8b23a-fca8-45f4-a09a-9c8b21f522cd6
1736546esmolol HCl 100 MG per 10 ML InjectionSY38a8b23a-fca8-45f4-a09a-9c8b21f522cd6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0404-9825-10004049825101 VIAL, SINGLE-DOSE in 1 BAG (0404-9825-10) / 10 mL in 1 VIAL, SINGLE-DOSE2022-01-090000-00-00NoNoCurrent