NDC 63187-626

MONTELUKAST

Montelukast

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

Product ID63187-626_3079e963-1ee8-4b6d-a4c0-4d35a9a43f2b
NDC63187-626
Product TypeHuman Prescription Drug
Proprietary NameMONTELUKAST
Generic NameMontelukast
Dosage FormTablet, Chewable
Route of AdministrationORAL
Marketing Start Date2014-12-01
Marketing CategoryANDA / ANDA
Application NumberANDA203037
Labeler NameProficient Rx LP
Substance NameMONTELUKAST SODIUM
Active Ingredient Strength5 mg/1
Pharm ClassesLeukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 63187-626-30

30 TABLET, CHEWABLE in 1 BOTTLE (63187-626-30)
Marketing Start Date2018-12-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63187-626-90 [63187062690]

MONTELUKAST TABLET, CHEWABLE
Marketing CategoryANDA
Application NumberANDA203037
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-12-01

NDC 63187-626-30 [63187062630]

MONTELUKAST TABLET, CHEWABLE
Marketing CategoryANDA
Application NumberANDA203037
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-12-01

NDC 63187-626-60 [63187062660]

MONTELUKAST TABLET, CHEWABLE
Marketing CategoryANDA
Application NumberANDA203037
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-12-01

Drug Details

Active Ingredients

IngredientStrength
MONTELUKAST SODIUM5 mg/1

OpenFDA Data

SPL SET ID:9705627c-283e-4743-b261-cfeb88d96e9b
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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