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Labetalol HCl in Sodium Chloride

These highlights do not include all the information needed to use LABETALOL HYDROCHLORIDE INJECTION safely and effectively. See full prescribing information for LABETALOL HYDROCHLORIDE. LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE injection , for intravenous use. LABETALOL HYDROCHLORIDE IN DEXTROSE injection , for intravenous use. LABETALOL HYDROCHLORIDE injection, for intravenous use. Initial U.S. Approval: 1984

Approved
Approval ID

99a715a0-4579-410c-b102-7ef6fab8db55

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Mar 1, 2022

Manufacturers
FDA

Hikma Pharmaceuticals USA Inc.

DUNS: 001230762

Products 4

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

LABETALOL HYDROCHLORIDE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0143-9364
Application NumberNDA213330
Product Classification
M
Marketing Category
C73594
G
Generic Name
LABETALOL HYDROCHLORIDE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMarch 1, 2022
FDA Product Classification

INGREDIENTS (6)

LABETALOL HYDROCHLORIDEActive
Quantity: 1 mg in 1 mL
Code: 1GEV3BAW9J
Classification: ACTIB
ANHYDROUS DEXTROSEInactive
Quantity: 9 mg in 1 mL
Code: 5SL0G7R0OK
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 7.2 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
EDETATE DISODIUMInactive
Quantity: 0.02 mg in 1 mL
Code: 7FLD91C86K
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT

LABETALOL HYDROCHLORIDE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0143-9363
Application NumberNDA213330
Product Classification
M
Marketing Category
C73594
G
Generic Name
LABETALOL HYDROCHLORIDE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMarch 1, 2022
FDA Product Classification

INGREDIENTS (6)

LABETALOL HYDROCHLORIDEActive
Quantity: 1 mg in 1 mL
Code: 1GEV3BAW9J
Classification: ACTIB
EDETATE DISODIUMInactive
Quantity: 0.02 mg in 1 mL
Code: 7FLD91C86K
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 7.2 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
ANHYDROUS DEXTROSEInactive
Quantity: 9 mg in 1 mL
Code: 5SL0G7R0OK
Classification: IACT

LABETALOL HYDROCHLORIDE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0143-9365
Application NumberNDA213330
Product Classification
M
Marketing Category
C73594
G
Generic Name
LABETALOL HYDROCHLORIDE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMarch 1, 2022
FDA Product Classification

INGREDIENTS (6)

SODIUM CHLORIDEInactive
Quantity: 7.2 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
ANHYDROUS DEXTROSEInactive
Quantity: 9 mg in 1 mL
Code: 5SL0G7R0OK
Classification: IACT
EDETATE DISODIUMInactive
Quantity: 0.02 mg in 1 mL
Code: 7FLD91C86K
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
LABETALOL HYDROCHLORIDEActive
Quantity: 1 mg in 1 mL
Code: 1GEV3BAW9J
Classification: ACTIB

Labetalol Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0143-9366
Application NumberNDA213330
Product Classification
M
Marketing Category
C73594
G
Generic Name
Labetalol Hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMarch 1, 2022
FDA Product Classification

INGREDIENTS (5)

LABETALOL HYDROCHLORIDEActive
Quantity: 1 mg in 1 mL
Code: 1GEV3BAW9J
Classification: ACTIB
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
EDETATE DISODIUMInactive
Quantity: 0.02 mg in 1 mL
Code: 7FLD91C86K
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
ANHYDROUS DEXTROSEInactive
Quantity: 45 mg in 1 mL
Code: 5SL0G7R0OK
Classification: IACT

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