NDC 71335-0696

Labetalol HCl

Labetalol Hcl

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

Product ID71335-0696_1cc047f3-b3d9-4782-9964-e05b8f1a4339
NDC71335-0696
Product TypeHuman Prescription Drug
Proprietary NameLabetalol HCl
Generic NameLabetalol Hcl
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date1998-08-04
Marketing CategoryANDA / ANDA
Application NumberANDA075113
Labeler NameBryant Ranch Prepack
Substance NameLABETALOL HYDROCHLORIDE
Active Ingredient Strength300 mg/1
Pharm ClassesAdrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 71335-0696-1

30 TABLET, FILM COATED in 1 BOTTLE (71335-0696-1)
Marketing Start Date2018-02-21
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71335-0696-3 [71335069603]

Labetalol HCl TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA075113
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-02-21

NDC 71335-0696-5 [71335069605]

Labetalol HCl TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA075113
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-02-21

NDC 71335-0696-4 [71335069604]

Labetalol HCl TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA075113
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-02-21

NDC 71335-0696-2 [71335069602]

Labetalol HCl TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA075113
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-02-21

NDC 71335-0696-1 [71335069601]

Labetalol HCl TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA075113
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-02-21

Drug Details

Active Ingredients

IngredientStrength
LABETALOL HYDROCHLORIDE300 mg/1

OpenFDA Data

SPL SET ID:19373e87-6885-42db-95dc-b8a72c61e254
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 896758
  • 896766

    • Pharmacological Class

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

    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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