NDC 0615-7687

Labetalol Hydrochloride

Labetalol Hydrochloride

Labetalol Hydrochloride 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 ID0615-7687_130580ab-9628-452b-b05f-2bd1781b2097
NDC0615-7687
Product TypeHuman Prescription Drug
Proprietary NameLabetalol Hydrochloride
Generic NameLabetalol Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2011-01-01
Marketing CategoryANDA / ANDA
Application NumberANDA074787
Labeler NameNCS HealthCare of KY, Inc dba Vangard Labs
Substance NameLABETALOL HYDROCHLORIDE
Active Ingredient Strength200 mg/1
Pharm ClassesAdrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 0615-7687-39

30 TABLET, FILM COATED in 1 BLISTER PACK (0615-7687-39)
Marketing Start Date2011-01-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0615-7687-39 [00615768739]

Labetalol Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA074787
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-01-01
Inactivation Date2019-11-13

Drug Details

Active Ingredients

IngredientStrength
LABETALOL HYDROCHLORIDE200 mg/1

OpenFDA Data

SPL SET ID:f1ae531d-8bd1-4c04-99b0-2ec2cc2fa666
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 896758
  • 896766
  • 896762
  • Pharmacological Class

    • 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

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.