NDC 0615-8130

Labetalol HCL

Labetalol Hydrochloride

Labetalol HCL is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Ncs Healthcare Of Ky, Inc Dba Vangard Labs. The primary component is Labetalol Hydrochloride.

Product ID0615-8130_4a4d945a-d675-483d-ba43-e6adda4ead30
NDC0615-8130
Product TypeHuman Prescription Drug
Proprietary NameLabetalol HCL
Generic NameLabetalol Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2012-07-24
Marketing End Date2022-01-31
Marketing CategoryANDA / ANDA
Application NumberANDA200908
Labeler NameNCS HealthCare of KY, Inc dba Vangard Labs
Substance NameLABETALOL HYDROCHLORIDE
Active Ingredient Strength100 mg/1
Pharm ClassesAdrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
NDC Exclude FlagN

Packaging

NDC 0615-8130-39

30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8130-39)
Marketing Start Date2018-07-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0615-8130-39 [00615813039]

Labetalol HCL TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA200908
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-06-26
Marketing End Date2022-01-31

Drug Details

Active Ingredients

IngredientStrength
LABETALOL HYDROCHLORIDE100 mg/1

OpenFDA Data

SPL SET ID:cce89d14-cc6b-4d86-b84b-309f56637e53
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 896758
  • 896762
  • 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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