NDC 0591-0607

Labetalol hydrochloride

Labetalol Hydrochloride

Labetalol hydrochloride is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Actavis Pharma, Inc.. The primary component is Labetalol Hydrochloride.

Product ID0591-0607_f542c90d-8e54-46f7-947b-772d46f74a87
NDC0591-0607
Product TypeHuman Prescription Drug
Proprietary NameLabetalol hydrochloride
Generic NameLabetalol Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date1998-08-03
Marketing CategoryANDA / ANDA
Application NumberANDA075133
Labeler NameActavis Pharma, Inc.
Substance NameLABETALOL HYDROCHLORIDE
Active Ingredient Strength300 mg/1
Pharm ClassesAdrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0591-0607-01

100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0591-0607-01)
Marketing Start Date1998-08-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0591-0607-10 [00591060710]

Labetalol hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA075133
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1998-08-03

NDC 0591-0607-05 [00591060705]

Labetalol hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA075133
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1998-08-03

NDC 0591-0607-01 [00591060701]

Labetalol hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA075133
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1998-08-03

Drug Details

Active Ingredients

IngredientStrength
LABETALOL HYDROCHLORIDE300 mg/1

OpenFDA Data

SPL SET ID:a5b65a9b-6b8a-48a4-9c72-0e605bb309eb
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 896758
  • 896766
  • 896762

    • Pharmacological Class

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