NDC 42291-621

Montelukast Sodium

Montelukast Sodium

Montelukast Sodium is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Avkare, Inc.. The primary component is Montelukast Sodium.

Product ID42291-621_8166ca03-8792-9639-e053-2a91aa0a985f
NDC42291-621
Product TypeHuman Prescription Drug
Proprietary NameMontelukast Sodium
Generic NameMontelukast Sodium
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2012-08-13
Marketing CategoryANDA / ANDA
Application NumberANDA201522
Labeler NameAvKARE, Inc.
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 42291-621-10

1000 TABLET, FILM COATED in 1 BOTTLE (42291-621-10)
Marketing Start Date2012-09-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 42291-621-10 [42291062110]

Montelukast Sodium TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA201522
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-09-14

NDC 42291-621-90 [42291062190]

Montelukast Sodium TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA201522
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-08-13

NDC 42291-621-55 [42291062155]

Montelukast Sodium TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA201522
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-02-02
Marketing End Date2018-09-19

NDC 42291-621-30 [42291062130]

Montelukast Sodium TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA201522
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-07-01
Marketing End Date2018-09-19

Drug Details

Active Ingredients

IngredientStrength
MONTELUKAST SODIUM10 mg/1

OpenFDA Data

SPL SET ID:ed2caffa-a75c-1c27-ae30-2d8280eaea7d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 200224
  • 311759
  • 242438
  • UPC Code
  • 0342291621909
  • 0342291623903
  • 0342291622906
  • 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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