NDC 13668-079

Montelukast Sodium

Montelukast Sodium

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

Product ID13668-079_8663d05f-bc28-4357-9620-ff3ca2996c27
NDC13668-079
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 NameTorrent Pharmaceuticals Limited
Substance NameMONTELUKAST SODIUM
Active Ingredient Strength4 mg/1
Pharm ClassesLeukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 13668-079-05

500 TABLET, CHEWABLE in 1 BOTTLE (13668-079-05)
Marketing Start Date2012-08-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 13668-079-74 [13668007974]

Montelukast Sodium TABLET, CHEWABLE
Marketing CategoryANDA
Application NumberANDA090984
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-08-03

NDC 13668-079-30 [13668007930]

Montelukast Sodium TABLET, CHEWABLE
Marketing CategoryANDA
Application NumberANDA090984
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-08-03

NDC 13668-079-05 [13668007905]

Montelukast Sodium TABLET, CHEWABLE
Marketing CategoryANDA
Application NumberANDA090984
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-08-03

NDC 13668-079-90 [13668007990]

Montelukast Sodium TABLET, CHEWABLE
Marketing CategoryANDA
Application NumberANDA090984
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-08-03

Drug Details

Active Ingredients

IngredientStrength
MONTELUKAST SODIUM4 mg/1

OpenFDA Data

SPL SET ID:da038cf6-cfad-43a4-ab8e-d81d028d6087
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 200224
  • 311759
  • 242438
    • UPC Code
  • 0313668080056
  • 0313668081053
  • 0313668079050

    • Pharmacological Class

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

    Medicade Reported Pricing

    13668007990 MONTELUKAST SOD 4 MG TAB CHEW

    Pricing Unit: EA | Drug Type:

    13668007930 MONTELUKAST SOD 4 MG TAB CHEW

    Pricing Unit: EA | Drug Type:

    13668007905 MONTELUKAST SOD 4 MG TAB CHEW

    Pricing Unit: EA | Drug Type:

    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.