NDC 0615-7748

Montelukast Sodium

Montelukast Sodium

Montelukast Sodium is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Ncs Healthcare Of Ky, Inc Dba Vangard Labs. The primary component is Montelukast Sodium.

Product ID0615-7748_508c39f3-66a8-4db2-b1ec-87533ab2ca03
NDC0615-7748
Product TypeHuman Prescription Drug
Proprietary NameMontelukast Sodium
Generic NameMontelukast Sodium
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2012-08-03
Marketing CategoryANDA / ANDA
Application NumberANDA078605
Labeler NameNCS HealthCare of KY, Inc dba Vangard Labs
Substance NameMONTELUKAST SODIUM
Active Ingredient Strength10 mg/1
Pharm ClassesLeukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 0615-7748-05

15 TABLET, FILM COATED in 1 BLISTER PACK (0615-7748-05)
Marketing Start Date2012-08-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0615-7748-05 [00615774805]

Montelukast Sodium TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078605
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-08-03
Inactivation Date2020-01-31

NDC 0615-7748-39 [00615774839]

Montelukast Sodium TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078605
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-08-03
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
MONTELUKAST SODIUM10 mg/1

OpenFDA Data

SPL SET ID:2d507e8c-d3e0-419b-9ad4-b712e52162de
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 200224
  • 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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