NDC 70518-1546

Labetalol HCL

Labetalol Hydrochloride

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

Product ID70518-1546_78765cc3-27dc-0373-e053-2991aa0a7fe1
NDC70518-1546
Product TypeHuman Prescription Drug
Proprietary NameLabetalol HCL
Generic NameLabetalol Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2018-10-17
Marketing CategoryANDA / ANDA
Application NumberANDA200908
Labeler NameREMEDYREPACK INC.
Substance NameLABETALOL HYDROCHLORIDE
Active Ingredient Strength100 mg/1
Pharm ClassesAdrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 70518-1546-1

30 TABLET, FILM COATED in 1 BLISTER PACK (70518-1546-1)
Marketing Start Date2021-06-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70518-1546-0 [70518154600]

Labetalol HCL TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA200908
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-10-17
Marketing End Date2020-05-27

Drug Details

Active Ingredients

IngredientStrength
LABETALOL HYDROCHLORIDE100 mg/1

OpenFDA Data

SPL SET ID:f81baebd-424d-4d39-893c-d9d622377c53
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 896758
  • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    0185-0010Labetalol HClLabetalol HCl
    0185-0117Labetalol HClLabetalol HCl
    0185-0118Labetalol HClLabetalol HCl
    0615-8130Labetalol HCLLabetalol Hydrochloride
    0615-8131Labetalol HCLLabetalol Hydrochloride
    68001-204Labetalol HClLabetalol HCl
    68001-205Labetalol HClLabetalol HCl
    68001-206Labetalol HClLabetalol HCl
    70518-0534Labetalol HClLabetalol HCl
    70518-1546Labetalol HCLLabetalol HCL
    71335-0696Labetalol HClLabetalol HCl
    71335-0733Labetalol HClLabetalol HCl
    49884-123Labetalol HCLLabetalol HCL
    49884-122Labetalol HCLLabetalol HCL
    49884-124Labetalol HCLLabetalol HCL
    50090-1161Labetalol HCLLabetalol HCL
    50090-1291Labetalol HCLLabetalol HCL
    51079-929Labetalol HClLabetalol HCl
    51079-928Labetalol HClLabetalol HCl
    52533-034Labetalol HClLabetalol HCl
    55154-5485Labetalol HClLabetalol HCl
    60687-125Labetalol HClLabetalol HCl
    60687-136Labetalol HClLabetalol HCl
    60687-114Labetalol HClLabetalol HCl
    63739-366Labetalol HClLabetalol HCl
    60760-610Labetalol HClLabetalol HCl
    71335-1410Labetalol HCLLabetalol HCL
    63629-2212Labetalol HCLLabetalol HCL
    63629-2216Labetalol HCLLabetalol HCL
    63629-2211Labetalol HCLLabetalol HCL
    63629-2213Labetalol HCLLabetalol HCL
    63629-2215Labetalol HCLLabetalol HCL
    0143-9366Labetalol HCl in DextroseLabetalol Hydrochloride
    0143-9363Labetalol HCl in Sodium ChlorideLABETALOL HYDROCHLORIDE
    0143-9364Labetalol HCl in Sodium ChlorideLABETALOL HYDROCHLORIDE
    0143-9365Labetalol HCl in Sodium ChlorideLABETALOL HYDROCHLORIDE
    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

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