Brevibloc
These highlights do not include all the information needed to use BREVIBLOC injection safely and effectively. See full prescribing information for BREVIBLOC injection.BREVIBLOC (Esmolol Hydrochloride) injection, for intravenous use Initial U.S. Approval: 1986
Approved
Approval ID
595cc3d5-1306-4828-aefa-5595219ffd62
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 15, 2023
Manufacturers
FDA
Baxter Healthcare Corporation
DUNS: 005083209
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Esmolol Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code10019-115
Application NumberNDA019386
Product Classification
M
Marketing Category
C73594
G
Generic Name
Esmolol Hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateApril 1, 2014
FDA Product Classification
INGREDIENTS (7)
ESMOLOL HYDROCHLORIDEActive
Quantity: 10 mg in 1 mL
Code: V05260LC8D
Classification: ACTIB
SODIUM ACETATEInactive
Quantity: 2.8 mg in 1 mL
Code: 4550K0SC9B
Classification: IACT
ACETIC ACIDInactive
Quantity: 0.546 mg in 1 mL
Code: Q40Q9N063P
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 5.9 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
Esmolol Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code10019-075
Application NumberNDA019386
Product Classification
M
Marketing Category
C73594
G
Generic Name
Esmolol Hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateApril 1, 2014
FDA Product Classification
INGREDIENTS (7)
SODIUM ACETATEInactive
Quantity: 2.8 mg in 1 mL
Code: 4550K0SC9B
Classification: IACT
ESMOLOL HYDROCHLORIDEActive
Quantity: 20 mg in 1 mL
Code: V05260LC8D
Classification: ACTIB
SODIUM CHLORIDEInactive
Quantity: 4.1 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
ACETIC ACIDInactive
Quantity: 0.546 mg in 1 mL
Code: Q40Q9N063P
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Esmolol Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code10019-055
Application NumberNDA019386
Product Classification
M
Marketing Category
C73594
G
Generic Name
Esmolol Hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateApril 1, 2014
FDA Product Classification
INGREDIENTS (7)
SODIUM ACETATEInactive
Quantity: 2.8 mg in 1 mL
Code: 4550K0SC9B
Classification: IACT
ESMOLOL HYDROCHLORIDEActive
Quantity: 10 mg in 1 mL
Code: V05260LC8D
Classification: ACTIB
ACETIC ACIDInactive
Quantity: 0.546 mg in 1 mL
Code: Q40Q9N063P
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 5.9 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT