NDC 68788-7387

MONTELUKAST

Montelukast

MONTELUKAST is a Oral Tablet, Chewable in the Human Prescription Drug category. It is labeled and distributed by Preferred Pharmaceuticals Inc.. The primary component is Montelukast Sodium.

Product ID68788-7387_5741eb27-cd88-45a6-9387-79a80f5a788a
NDC68788-7387
Product TypeHuman Prescription Drug
Proprietary NameMONTELUKAST
Generic NameMontelukast
Dosage FormTablet, Chewable
Route of AdministrationORAL
Marketing Start Date2016-09-13
Marketing CategoryANDA / ANDA
Application NumberANDA203037
Labeler NamePreferred Pharmaceuticals Inc.
Substance NameMONTELUKAST SODIUM
Active Ingredient Strength5 mg/1
Pharm ClassesLeukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA]
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 68788-7387-9

90 TABLET, CHEWABLE in 1 BOTTLE (68788-7387-9)
Marketing Start Date2016-09-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68788-7387-4 [68788738704]

MONTELUKAST TABLET, CHEWABLE
Marketing CategoryANDA
Application NumberANDA203037
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-09-13

NDC 68788-7387-9 [68788738709]

MONTELUKAST TABLET, CHEWABLE
Marketing CategoryANDA
Application NumberANDA203037
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-09-13

NDC 68788-7387-2 [68788738702]

MONTELUKAST TABLET, CHEWABLE
Marketing CategoryANDA
Application NumberANDA203037
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-09-13

NDC 68788-7387-3 [68788738703]

MONTELUKAST TABLET, CHEWABLE
Marketing CategoryANDA
Application NumberANDA203037
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-09-13

NDC 68788-7387-1 [68788738701]

MONTELUKAST TABLET, CHEWABLE
Marketing CategoryANDA
Application NumberANDA203037
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-09-13

NDC 68788-7387-6 [68788738706]

MONTELUKAST TABLET, CHEWABLE
Marketing CategoryANDA
Application NumberANDA203037
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-09-13

Drug Details

Active Ingredients

IngredientStrength
MONTELUKAST SODIUM5 mg/1

OpenFDA Data

SPL SET ID:19fdb2f0-05ae-4d30-966f-d229bb9acaf8
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 242438

    • Pharmacological Class

    • 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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