NDC 55154-8075

Montelukast

Montelukast

Montelukast is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Cardinal Health. The primary component is Montelukast Sodium.

Product ID55154-8075_0ae8f61a-ce7b-4336-962d-b84934b11d1a
NDC55154-8075
Product TypeHuman Prescription Drug
Proprietary NameMontelukast
Generic NameMontelukast
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2014-09-10
Marketing CategoryANDA / ANDA
Application NumberANDA202843
Labeler NameCardinal Health
Substance NameMONTELUKAST SODIUM
Active Ingredient Strength10 mg/1
Pharm ClassesLeukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 55154-8075-0

10 BLISTER PACK in 1 BAG (55154-8075-0) > 1 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Start Date2014-09-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55154-8075-0 [55154807500]

Montelukast TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA202843
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-09-10

Drug Details

Active Ingredients

IngredientStrength
MONTELUKAST SODIUM10 mg/1

OpenFDA Data

SPL SET ID:9287d2f1-2414-4ee2-aecc-b6b59c6a0a4c
Manufacturer
UNII
UPC Code
  • 0055154807500
  • Pharmacological Class

    • Leukotriene Receptor Antagonist [EPC]
    • Leukotriene Receptor Antagonists [MoA]
    • Leukotriene Receptor Antagonist [EPC]
    • Leukotriene Receptor Antagonists [MoA]

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

    NDCBrand NameGeneric Name
    0143-9649MONTELUKASTMONTELUKAST
    0143-9650MONTELUKASTMONTELUKAST
    0143-9651MONTELUKASTMONTELUKAST
    0781-5554MontelukastMontelukast
    0781-5555MontelukastMontelukast
    0781-5560MontelukastMontelukast
    0904-6808MontelukastMontelukast
    31722-726MontelukastMontelukast
    33342-102MontelukastMontelukast
    50090-6108MontelukastMontelukast
    50268-556MontelukastMontelukast
    51128-501MONTELUKASTMONTELUKAST
    51128-502MONTELUKASTMONTELUKAST
    51128-503MONTELUKASTMONTELUKAST
    54458-890MontelukastMontelukast
    55154-8075MontelukastMontelukast
    63187-626MONTELUKASTMONTELUKAST
    63629-4886MontelukastMontelukast
    68001-361MontelukastMontelukast
    68071-1652MONTELUKASTMONTELUKAST
    68071-4034MontelukastMontelukast
    68645-560MontelukastMontelukast
    68788-7387MONTELUKASTMONTELUKAST
    69452-105MONTELUKASTMONTELUKAST
    69452-107MONTELUKASTMONTELUKAST
    69452-106MONTELUKASTMONTELUKAST
    70518-1031MontelukastMontelukast
    70518-2603MontelukastMontelukast
    27241-017MONTELUKAST SODIUMMONTELUKAST
    53217-357MONTELUKAST SODIUMMONTELUKAST

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