NDC 72266-103

Labetalol Hydrochloride

Labetalol Hydrochloride

Labetalol Hydrochloride is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Fosun Pharma Usa Inc.. The primary component is Labetalol Hydrochloride.

Product ID72266-103_838935cb-9c42-5121-e053-2a91aa0a6ee4
NDC72266-103
Product TypeHuman Prescription Drug
Proprietary NameLabetalol Hydrochloride
Generic NameLabetalol Hydrochloride
Dosage FormInjection
Route of AdministrationINTRAVENOUS
Marketing Start Date2019-04-02
Marketing CategoryANDA / ANDA
Application NumberANDA090699
Labeler NameFosun Pharma USA Inc.
Substance NameLABETALOL HYDROCHLORIDE
Active Ingredient Strength5 mg/mL
Pharm ClassesAdrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 72266-103-01

1 VIAL, MULTI-DOSE in 1 CARTON (72266-103-01) > 40 mL in 1 VIAL, MULTI-DOSE
Marketing Start Date2019-04-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 72266-103-03 [72266010303]

Labetalol Hydrochloride INJECTION
Marketing CategoryANDA
Application NumberANDA090699
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-04-02
Marketing End Date2019-06-19

NDC 72266-103-01 [72266010301]

Labetalol Hydrochloride INJECTION
Marketing CategoryANDA
Application NumberANDA090699
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-04-02

Drug Details

Active Ingredients

IngredientStrength
LABETALOL HYDROCHLORIDE5 mg/mL

OpenFDA Data

SPL SET ID:4a5ffab2-a3b8-411e-992d-7f38d508643a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 896771
  • UPC Code
  • 0372266103017
  • 0372266103055
  • 0372266102102
  • 0372266102010
  • 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
    0904-5928Labetalol hydrochlorideLabetalol hydrochloride
    0904-5929Labetalol hydrochlorideLabetalol hydrochloride
    0904-5930Labetalol hydrochlorideLabetalol hydrochloride
    10135-711Labetalol HydrochlorideLabetalol
    10135-712Labetalol HydrochlorideLabetalol
    10135-713Labetalol HydrochlorideLabetalol
    14803-502Labetalol HydrochlorideLabetalol Hydrochloride
    14803-503Labetalol HydrochlorideLabetalol Hydrochloride
    14803-504Labetalol HydrochlorideLabetalol Hydrochloride
    17478-420Labetalol HydrochlorideLabetalol Hydrochloride
    21695-592Labetalol hydrochlorideLabetalol hydrochloride
    21695-988Labetalol hydrochlorideLabetalol hydrochloride
    21695-994Labetalol hydrochlorideLabetalol hydrochloride
    23155-723Labetalol HydrochlorideLabetalol Hydrochloride
    23155-724Labetalol HydrochlorideLabetalol Hydrochloride
    23155-725Labetalol HydrochlorideLabetalol Hydrochloride
    24979-168Labetalol HydrochlorideLabetalol Hydrochloride
    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

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