NDC 51079-928

Labetalol HCl

Labetalol Hcl

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

Product ID51079-928_7c61eb26-c81b-dad1-e053-2a91aa0a5803
NDC51079-928
Product TypeHuman Prescription Drug
Proprietary NameLabetalol HCl
Generic NameLabetalol Hcl
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2000-01-15
Marketing End Date2019-11-30
Marketing CategoryANDA / ANDA
Application NumberANDA075113
Labeler NameMylan Institutional Inc.
Substance NameLABETALOL HYDROCHLORIDE
Active Ingredient Strength100 mg/1
Pharm ClassesAdrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
NDC Exclude FlagN

Packaging

NDC 51079-928-20

100 BLISTER PACK in 1 CARTON (51079-928-20) > 1 TABLET, FILM COATED in 1 BLISTER PACK (51079-928-01)
Marketing Start Date2000-01-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 51079-928-20 [51079092820]

Labetalol HCl TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA075113
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2000-01-15
Marketing End Date2019-11-30

NDC 51079-928-01 [51079092801]

Labetalol HCl TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA075113
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2000-01-15
Marketing End Date2019-11-30

Drug Details

Active Ingredients

IngredientStrength
LABETALOL HYDROCHLORIDE100 mg/1

OpenFDA Data

SPL SET ID:f900dfb7-7a0d-4f56-a082-d7bd76f366bf
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 896758
  • 896762

    • Pharmacological Class

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

    Medicade Reported Pricing

    51079092820 LABETALOL HCL 100 MG TABLET

    Pricing Unit: EA | Drug Type:

    51079092801 LABETALOL HCL 100 MG TABLET

    Pricing Unit: EA | Drug Type:

    NDC Crossover Matching brand name "Labetalol HCl" or generic name "Labetalol Hcl"

    NDCBrand NameGeneric Name
    0185-0010Labetalol HClLabetalol HCl
    0185-0117Labetalol HClLabetalol HCl
    0185-0118Labetalol HClLabetalol HCl
    0615-8130Labetalol HCLLabetalol Hydrochloride
    0615-8131Labetalol HCLLabetalol Hydrochloride
    49884-122Labetalol HCLLabetalol Hydrochloride
    49884-123Labetalol HCLLabetalol Hydrochloride
    49884-124Labetalol HCLLabetalol Hydrochloride
    50090-1161Labetalol HCLLabetalol Hydrochloride
    50090-1290Labetalol HCLLabetalol Hydrochloride
    50090-1291Labetalol HCLLabetalol Hydrochloride
    51079-928Labetalol HClLabetalol HCl
    51079-929Labetalol HClLabetalol HCl
    51662-1602LABETALOL HClLABETALOL HCl
    52533-034Labetalol HClLabetalol HCl
    55154-5485Labetalol HClLabetalol HCl
    60687-114Labetalol HClLabetalol HCl
    60687-125Labetalol HClLabetalol HCl
    60687-136Labetalol HClLabetalol HCl
    60760-610Labetalol HClLabetalol HCl
    60760-628Labetalol HCLLabetalol Hydrochloride
    63629-2211Labetalol HCLLabetalol Hydrochloride
    63629-2212Labetalol HCLLabetalol Hydrochloride
    63629-2213Labetalol HCLLabetalol Hydrochloride
    63629-2214Labetalol HCLLabetalol Hydrochloride
    63629-2215Labetalol HCLLabetalol Hydrochloride
    63629-2216Labetalol 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
    63739-366Labetalol HClLabetalol HCl
    71335-1410Labetalol HCLLabetalol HCL
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