NDC 0409-2267

Labetalol Hydrochloride

Labetalol Hydrochloride

Labetalol Hydrochloride is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Hospira, Inc.. The primary component is Labetalol Hydrochloride.

Product ID0409-2267_254b1317-2ac9-4e9c-9488-6291ed04fba6
NDC0409-2267
Product TypeHuman Prescription Drug
Proprietary NameLabetalol Hydrochloride
Generic NameLabetalol Hydrochloride
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2005-12-30
Marketing CategoryANDA / ANDA
Application NumberANDA075240
Labeler NameHospira, Inc.
Substance NameLABETALOL HYDROCHLORIDE
Active Ingredient Strength5 mg/mL
Pharm ClassesAdrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 0409-2267-20

1 VIAL, MULTI-DOSE in 1 CARTON (0409-2267-20) > 20 mL in 1 VIAL, MULTI-DOSE
Marketing Start Date2006-02-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0409-2267-26 [00409226726]

Labetalol Hydrochloride INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA075240
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2013-10-16
Marketing End Date2018-12-01

NDC 0409-2267-20 [00409226720]

Labetalol Hydrochloride INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA075240
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2006-02-01

NDC 0409-2267-25 [00409226725]

Labetalol Hydrochloride INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA075240
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2013-07-22
Marketing End Date2018-11-01

NDC 0409-2267-54 [00409226754]

Labetalol Hydrochloride INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA075240
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2005-12-30

Drug Details

Active Ingredients

IngredientStrength
LABETALOL HYDROCHLORIDE5 mg/mL

OpenFDA Data

SPL SET ID:abfc6b75-1ed5-41f1-0484-4597488237bc
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 896771

    • Pharmacological Class

    • Adrenergic beta-Antagonists [MoA]
    • beta-Adrenergic Blocker [EPC]

    NDC Crossover Matching brand name "Labetalol Hydrochloride" or generic name "Labetalol Hydrochloride"

    NDCBrand NameGeneric Name
    0143-9320Labetalol HydrochlorideLabetalol Hydrochloride
    0143-9622Labetalol HydrochlorideLabetalol Hydrochloride
    0143-9623Labetalol HydrochlorideLabetalol Hydrochloride
    0409-2267Labetalol HydrochlorideLabetalol Hydrochloride
    0409-2339Labetalol HydrochlorideLabetalol Hydrochloride
    0591-0605Labetalol hydrochlorideLabetalol hydrochloride
    0591-0606Labetalol hydrochlorideLabetalol hydrochloride
    0591-0607Labetalol hydrochlorideLabetalol hydrochloride
    0615-4539Labetalol HydrochlorideLabetalol Hydrochloride
    0615-7686Labetalol HydrochlorideLabetalol Hydrochloride
    0615-7687Labetalol HydrochlorideLabetalol Hydrochloride
    0615-7688Labetalol HydrochlorideLabetalol Hydrochloride
    0641-6252Labetalol HydrochlorideLabetalol Hydrochloride
    0904-5928Labetalol hydrochlorideLabetalol hydrochloride
    0904-5929Labetalol hydrochlorideLabetalol hydrochloride
    0904-5930Labetalol hydrochlorideLabetalol hydrochloride
    0904-7109Labetalol HydrochlorideLabetalol Hydrochloride
    0904-7110Labetalol HydrochlorideLabetalol Hydrochloride
    0904-7111Labetalol HydrochlorideLabetalol Hydrochloride
    10135-711Labetalol HydrochlorideLabetalol
    68001-381Labetalol HydrochlorideLabetalol Hydrochloride
    68001-383Labetalol HydrochlorideLabetalol Hydrochloride
    68001-382Labetalol HydrochlorideLabetalol Hydrochloride
    68071-3180Labetalol HydrochlorideLabetalol Hydrochloride
    68083-111Labetalol HydrochlorideLabetalol Hydrochloride
    68258-6047Labetalol HydrochlorideLabetalol Hydrochloride
    68382-800Labetalol HydrochlorideLabetalol Hydrochloride
    68382-798Labetalol HydrochlorideLabetalol Hydrochloride
    68382-799Labetalol HydrochlorideLabetalol Hydrochloride
    69292-501Labetalol HydrochlorideLabetalol Hydrochloride
    69292-503Labetalol HydrochlorideLabetalol Hydrochloride
    69292-502Labetalol HydrochlorideLabetalol Hydrochloride
    70518-0027Labetalol HydrochlorideLabetalol Hydrochloride
    70518-1163Labetalol HydrochlorideLabetalol Hydrochloride
    70518-1132Labetalol HydrochlorideLabetalol Hydrochloride
    70518-1887Labetalol HydrochlorideLabetalol Hydrochloride
    70771-1163Labetalol HydrochlorideLabetalol Hydrochloride
    70771-1165Labetalol HydrochlorideLabetalol Hydrochloride
    70771-1164Labetalol HydrochlorideLabetalol Hydrochloride
    71205-095Labetalol hydrochlorideLabetalol hydrochloride
    71335-0118Labetalol HydrochlorideLabetalol Hydrochloride
    72266-103Labetalol HydrochlorideLabetalol Hydrochloride
    72266-102Labetalol HydrochlorideLabetalol Hydrochloride
    17478-420Labetalol HydrochlorideLabetalol Hydrochloride
    21695-994Labetalol hydrochlorideLabetalol hydrochloride
    21695-988Labetalol hydrochlorideLabetalol hydrochloride
    21695-592Labetalol hydrochlorideLabetalol hydrochloride
    24979-169Labetalol HydrochlorideLabetalol Hydrochloride
    24979-170Labetalol HydrochlorideLabetalol Hydrochloride
    24979-168Labetalol HydrochlorideLabetalol Hydrochloride
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