NDC 10135-642

Labetalol

Labetalol

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

Product ID10135-642_d283e94b-266e-40c6-bee9-856ce2d6ceb9
NDC10135-642
Product TypeHuman Prescription Drug
Proprietary NameLabetalol
Generic NameLabetalol
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2018-04-01
Marketing CategoryANDA / ANDA
Application NumberANDA075215
Labeler NameMarlex Pharmaceuticals Inc
Substance NameLABETALOL
Active Ingredient Strength200 mg/1
Pharm ClassesAdrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 10135-642-01

100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (10135-642-01)
Marketing Start Date2018-04-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 10135-642-01 [10135064201]

Labetalol TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA075215
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-04-01
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
LABETALOL200 mg/1

OpenFDA Data

SPL SET ID:b4c13317-88eb-48f2-aba2-50f01c8ff938
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 896758
  • 896766
  • 896762
  • UPC Code
  • 0310135643011
  • 0310135642014
  • 0310135641017
  • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    10135-641LabetalolLabetalol
    10135-642LabetalolLabetalol
    10135-643LabetalolLabetalol
    10135-711Labetalol HydrochlorideLabetalol
    10135-712Labetalol HydrochlorideLabetalol
    10135-713Labetalol HydrochlorideLabetalol
    58657-605Labetalol HydrochlorideLabetalol
    58657-606Labetalol HydrochlorideLabetalol
    58657-607Labetalol HydrochlorideLabetalol

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