NDC 0054-0259

Montelukast Sodium

Montelukast Sodium

Montelukast Sodium is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by West-ward Pharmaceuticals Corp.. The primary component is Montelukast Sodium.

Product ID0054-0259_3be73e09-6003-4d61-ab70-959ea8d4cf66
NDC0054-0259
Product TypeHuman Prescription Drug
Proprietary NameMontelukast Sodium
Generic NameMontelukast Sodium
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2012-08-03
Marketing CategoryANDA / ANDA
Application NumberANDA090655
Labeler NameWest-Ward Pharmaceuticals Corp.
Substance NameMONTELUKAST SODIUM
Active Ingredient Strength10 mg/1
Pharm ClassesLeukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0054-0259-22

90 TABLET in 1 BOTTLE (0054-0259-22)
Marketing Start Date2012-08-03
Marketing End Date2021-02-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0054-0259-22 [00054025922]

Montelukast Sodium TABLET
Marketing CategoryANDA
Application NumberANDA090655
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-08-03
Marketing End Date2021-02-28

NDC 0054-0259-31 [00054025931]

Montelukast Sodium TABLET
Marketing CategoryANDA
Application NumberANDA090655
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-08-03
Marketing End Date2012-08-03

NDC 0054-0259-13 [00054025913]

Montelukast Sodium TABLET
Marketing CategoryANDA
Application NumberANDA090655
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-08-03
Marketing End Date2021-01-31

Drug Details

Active Ingredients

IngredientStrength
MONTELUKAST SODIUM10 mg/1

OpenFDA Data

SPL SET ID:d606a983-3146-4f50-a9d5-634cb4aef580
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 200224
  • 311759
  • 242438
  • UPC Code
  • 0300540288136
  • 0300540259136
  • 0300540289133
  • 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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