NDC 59746-359

Montelukast sodium chewable

Montelukast Sodium

Montelukast sodium chewable is a Oral Tablet, Chewable in the Human Prescription Drug category. It is labeled and distributed by Jubilant Cadista Pharmaceuticals Inc.. The primary component is Montelukast Sodium.

Product ID59746-359_758593f9-d960-4ac8-8ada-02aeae115244
NDC59746-359
Product TypeHuman Prescription Drug
Proprietary NameMontelukast sodium chewable
Generic NameMontelukast Sodium
Dosage FormTablet, Chewable
Route of AdministrationORAL
Marketing Start Date2015-02-28
Marketing CategoryANDA / ANDA
Application NumberANDA203795
Labeler NameJubilant Cadista 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 59746-359-30

30 TABLET, CHEWABLE in 1 BOTTLE (59746-359-30)
Marketing Start Date2015-02-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 59746-359-12 [59746035912]

Montelukast sodium chewable TABLET, CHEWABLE
Marketing CategoryANDA
Application NumberANDA203795
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-02-28
Marketing End Date2019-03-31

NDC 59746-359-32 [59746035932]

Montelukast sodium chewable TABLET, CHEWABLE
Marketing CategoryANDA
Application NumberANDA203795
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-02-28
Marketing End Date2019-03-31

NDC 59746-359-01 [59746035901]

Montelukast sodium chewable TABLET, CHEWABLE
Marketing CategoryANDA
Application NumberANDA203795
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-02-28
Marketing End Date2019-03-31

NDC 59746-359-30 [59746035930]

Montelukast sodium chewable TABLET, CHEWABLE
Marketing CategoryANDA
Application NumberANDA203795
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-02-28
Marketing End Date2019-03-31

NDC 59746-359-10 [59746035910]

Montelukast sodium chewable TABLET, CHEWABLE
Marketing CategoryANDA
Application NumberANDA203795
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-02-28
Marketing End Date2019-03-31

NDC 59746-359-90 [59746035990]

Montelukast sodium chewable TABLET, CHEWABLE
Marketing CategoryANDA
Application NumberANDA203795
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-02-28
Marketing End Date2019-03-31

NDC 59746-359-05 [59746035905]

Montelukast sodium chewable TABLET, CHEWABLE
Marketing CategoryANDA
Application NumberANDA203795
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-02-28
Marketing End Date2019-03-31

Drug Details

Active Ingredients

IngredientStrength
MONTELUKAST SODIUM5 mg/1

OpenFDA Data

SPL SET ID:76d4a034-0082-1d94-5f92-6b071da7cadd
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 311759
  • 242438
    • UPC Code
  • 0359746358327
  • 0359746359324
  • 0359746359300
  • 0359746358303

    • Pharmacological Class

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

    Medicade Reported Pricing

    59746035990 MONTELUKAST SOD 5 MG TAB CHEW

    Pricing Unit: EA | Drug Type:

    59746035930 MONTELUKAST SOD 5 MG TAB CHEW

    Pricing Unit: EA | Drug Type:

    NDC Crossover Matching brand name "Montelukast sodium chewable" or generic name "Montelukast Sodium"

    NDCBrand NameGeneric Name
    59746-358Montelukast sodium chewableMontelukast sodium chewable
    59746-359Montelukast sodium chewableMontelukast sodium chewable
    0054-0259Montelukast SodiumMontelukast Sodium
    0054-0288Montelukast SodiumMontelukast Sodium
    0054-0289Montelukast SodiumMontelukast Sodium
    0093-7424Montelukast SodiumMontelukast Sodium
    0093-7425Montelukast SodiumMontelukast Sodium
    0006-1711SINGULAIRmontelukast sodium
    0006-3841SINGULAIRmontelukast sodium
    0006-9117SINGULAIRmontelukast sodium
    0006-9275SINGULAIRmontelukast sodium
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.