NDC 67046-468

montelukast sodium

Montelukast Sodium

montelukast sodium is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Contract Pharmacy Services-pa. The primary component is Montelukast Sodium.

Product ID67046-468_59b9449b-3ad0-39f7-e053-2a91aa0a6db2
NDC67046-468
Product TypeHuman Prescription Drug
Proprietary Namemontelukast sodium
Generic NameMontelukast Sodium
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2017-09-21
Marketing CategoryANDA / ANDA
Application NumberANDA204290
Labeler NameContract Pharmacy Services-PA
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 67046-468-07

7 TABLET, FILM COATED in 1 BLISTER PACK (67046-468-07)
Marketing Start Date2017-09-21
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 67046-468-14 [67046046814]

montelukast sodium TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA204290
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-09-21

NDC 67046-468-30 [67046046830]

montelukast sodium TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA204290
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-09-21

NDC 67046-468-07 [67046046807]

montelukast sodium TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA204290
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-09-21

NDC 67046-468-20 [67046046820]

montelukast sodium TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA204290
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-09-21

NDC 67046-468-60 [67046046860]

montelukast sodium TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA204290
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-09-21

NDC 67046-468-21 [67046046821]

montelukast sodium TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA204290
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-09-21

NDC 67046-468-28 [67046046828]

montelukast sodium TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA204290
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-09-21

NDC 67046-468-15 [67046046815]

montelukast sodium TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA204290
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-09-21

Drug Details

Active Ingredients

IngredientStrength
MONTELUKAST SODIUM10 mg/1

OpenFDA Data

SPL SET ID:59b9449b-3acf-39f7-e053-2a91aa0a6db2
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 200224
    • UPC Code
  • 0329300220100

    • Pharmacological Class

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