NDC 68788-8988

Montelukast Sodium

Montelukast Sodium

Montelukast Sodium 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 ID68788-8988_83415087-ed71-403a-b111-b3ac0959e179
NDC68788-8988
Product TypeHuman Prescription Drug
Proprietary NameMontelukast Sodium
Generic NameMontelukast Sodium
Dosage FormTablet, Chewable
Route of AdministrationORAL
Marketing Start Date2016-02-01
Marketing CategoryANDA / ANDA
Application NumberANDA091588
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 68788-8988-9

90 TABLET, CHEWABLE in 1 BOTTLE (68788-8988-9)
Marketing Start Date2016-02-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68788-8988-4 [68788898804]

Montelukast Sodium TABLET, CHEWABLE
Marketing CategoryANDA
Application NumberANDA091588
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-02-01
Marketing End Date2019-10-31

NDC 68788-8988-6 [68788898806]

Montelukast Sodium TABLET, CHEWABLE
Marketing CategoryANDA
Application NumberANDA091588
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-02-01
Marketing End Date2019-10-31

NDC 68788-8988-1 [68788898801]

Montelukast Sodium TABLET, CHEWABLE
Marketing CategoryANDA
Application NumberANDA091588
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-02-01
Marketing End Date2019-10-31

NDC 68788-8988-2 [68788898802]

Montelukast Sodium TABLET, CHEWABLE
Marketing CategoryANDA
Application NumberANDA091588
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-02-01
Marketing End Date2019-10-31

NDC 68788-8988-3 [68788898803]

Montelukast Sodium TABLET, CHEWABLE
Marketing CategoryANDA
Application NumberANDA091588
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-02-01
Marketing End Date2019-10-31

NDC 68788-8988-9 [68788898809]

Montelukast Sodium TABLET, CHEWABLE
Marketing CategoryANDA
Application NumberANDA091588
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-02-01
Marketing End Date2019-10-31

Drug Details

Active Ingredients

IngredientStrength
MONTELUKAST SODIUM5 mg/1

OpenFDA Data

SPL SET ID:f8e39c21-ed2d-45b3-b2ec-8850a1b06c6b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 242438

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    0054-0259Montelukast SodiumMontelukast Sodium
    0054-0288Montelukast SodiumMontelukast Sodium
    0054-0289Montelukast SodiumMontelukast Sodium
    0093-7424Montelukast SodiumMontelukast Sodium
    0093-7425Montelukast SodiumMontelukast Sodium
    68001-248montelukast sodiummontelukast sodium
    68071-4047Montelukast SodiumMontelukast Sodium
    68071-4054Montelukast SodiumMontelukast Sodium
    68071-3355Montelukast SodiumMontelukast Sodium
    68084-875Montelukast SodiumMontelukast Sodium
    68151-3494Montelukast SodiumMontelukast Sodium
    68151-4186Montelukast SodiumMontelukast Sodium
    68151-3498Montelukast SodiumMontelukast Sodium
    68151-4338Montelukast SodiumMontelukast Sodium
    68462-392montelukast sodiummontelukast sodium
    68788-6410Montelukast SodiumMontelukast Sodium
    68788-6946Montelukast SodiumMontelukast Sodium
    68788-8988Montelukast SodiumMontelukast Sodium
    68788-7064Montelukast SodiumMontelukast Sodium
    68788-9438Montelukast SodiumMontelukast Sodium
    68788-9439Montelukast SodiumMontelukast Sodium
    70436-091Montelukast SodiumMontelukast Sodium
    70436-090Montelukast SodiumMontelukast Sodium
    70518-0172Montelukast SodiumMontelukast Sodium
    70518-0294MONTELUKAST SODIUMMONTELUKAST SODIUM
    70518-0684Montelukast SodiumMontelukast Sodium
    70518-0331Montelukast SodiumMontelukast Sodium
    70518-0805Montelukast SodiumMontelukast Sodium
    70518-1075Montelukast SodiumMontelukast Sodium
    70518-1085Montelukast SodiumMontelukast Sodium
    70518-1784Montelukast SodiumMontelukast Sodium
    0603-4655Montelukast SodiumMontelukast Sodium
    70934-202Montelukast SodiumMontelukast Sodium
    71205-128MONTELUKAST SODIUMMONTELUKAST SODIUM
    0603-4653Montelukast SodiumMontelukast Sodium
    0603-4654Montelukast SodiumMontelukast Sodium
    71335-0629MONTELUKAST SODIUMMONTELUKAST SODIUM
    71335-0611Montelukast SodiumMontelukast Sodium
    71205-181montelukast sodiummontelukast sodium
    71335-0514Montelukast SodiumMontelukast Sodium
    71335-0620Montelukast SodiumMontelukast Sodium
    71335-0301Montelukast SodiumMontelukast Sodium
    71610-129Montelukast SodiumMontelukast Sodium
    71610-026Montelukast SodiumMontelukast Sodium
    71610-051Montelukast SodiumMontelukast Sodium
    0615-7748Montelukast SodiumMontelukast Sodium
    0615-7983Montelukast SodiumMontelukast Sodium
    0904-6529Montelukast SodiumMontelukast Sodium
    13668-079Montelukast SodiumMontelukast Sodium
    13668-081Montelukast SodiumMontelukast Sodium
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