NDC 33342-102

Montelukast

Montelukast

Montelukast is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Macleods Pharmaceuticals Limited. The primary component is Montelukast Sodium.

Product ID33342-102_20eecb71-3239-49b6-ae2c-126acc978124
NDC33342-102
Product TypeHuman Prescription Drug
Proprietary NameMontelukast
Generic NameMontelukast
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2014-09-11
Marketing CategoryANDA / ANDA
Application NumberANDA203366
Labeler NameMacleods Pharmaceuticals Limited
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 33342-102-07

30 TABLET in 1 BOTTLE (33342-102-07)
Marketing Start Date2014-09-11
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 33342-102-12 [33342010212]

Montelukast TABLET
Marketing CategoryANDA
Application NumberANDA203366
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-09-11

NDC 33342-102-15 [33342010215]

Montelukast TABLET
Marketing CategoryANDA
Application NumberANDA203366
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-09-11

NDC 33342-102-07 [33342010207]

Montelukast TABLET
Marketing CategoryANDA
Application NumberANDA203366
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-09-11

NDC 33342-102-10 [33342010210]

Montelukast TABLET
Marketing CategoryANDA
Application NumberANDA203366
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-09-11

NDC 33342-102-39 [33342010239]

Montelukast TABLET
Marketing CategoryANDA
Application NumberANDA203366
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-09-11

Drug Details

Active Ingredients

IngredientStrength
MONTELUKAST SODIUM10 mg/1

OpenFDA Data

SPL SET ID:e0c5b856-3f70-4ca6-9763-a90673bb82fb
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 200224
  • Pharmacological Class

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

    Medicade Reported Pricing

    33342010215 MONTELUKAST SOD 10 MG TABLET

    Pricing Unit: EA | Drug Type:

    33342010210 MONTELUKAST SOD 10 MG TABLET

    Pricing Unit: EA | Drug Type:

    33342010207 MONTELUKAST SOD 10 MG TABLET

    Pricing Unit: EA | Drug Type:

    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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