NDC 68071-1755

Montelukast Sodium

Montelukast Sodium

Montelukast Sodium is a Oral Tablet, Chewable in the Human Prescription Drug category. It is labeled and distributed by Nucare Pharmaceuticals,inc.. The primary component is Montelukast Sodium.

Product ID68071-1755_8800cf59-afcc-35a0-e053-2995a90a7dca
NDC68071-1755
Product TypeHuman Prescription Drug
Proprietary NameMontelukast Sodium
Generic NameMontelukast Sodium
Dosage FormTablet, Chewable
Route of AdministrationORAL
Marketing Start Date2012-08-03
Marketing CategoryANDA / ANDA
Application NumberANDA090984
Labeler NameNuCare Pharmaceuticals,Inc.
Substance NameMONTELUKAST SODIUM
Active Ingredient Strength5 mg/1
Pharm ClassesLeukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 68071-1755-9

90 TABLET, CHEWABLE in 1 BOTTLE (68071-1755-9)
Marketing Start Date2019-05-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68071-1755-9 [68071175509]

Montelukast Sodium TABLET, CHEWABLE
Marketing CategoryANDA
Application NumberANDA090984
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-05-03

Drug Details

Active Ingredients

IngredientStrength
MONTELUKAST SODIUM5 mg/1

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.