NDC 51128-502

MONTELUKAST

Montelukast

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

Product ID51128-502_9eeede6e-480e-4b27-e053-2a95a90a34dc
NDC51128-502
Product TypeHuman Prescription Drug
Proprietary NameMONTELUKAST
Generic NameMontelukast
Dosage FormTablet, Chewable
Route of AdministrationORAL
Marketing Start Date2014-12-01
Marketing CategoryANDA / ANDA
Application NumberANDA203037
Labeler NameRecipharm Pharmaservices Private Limited
Substance NameMONTELUKAST SODIUM
Active Ingredient Strength4 mg/1
Pharm ClassesLeukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 51128-502-01

30 TABLET, CHEWABLE in 1 BOTTLE (51128-502-01)
Marketing Start Date2014-12-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 51128-502-03 [51128050203]

MONTELUKAST TABLET, CHEWABLE
Marketing CategoryANDA
Application NumberANDA203037
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-12-01
Inactivation Date2020-01-31
Reactivation Date2020-02-19

NDC 51128-502-01 [51128050201]

MONTELUKAST TABLET, CHEWABLE
Marketing CategoryANDA
Application NumberANDA203037
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-12-01
Inactivation Date2020-01-31
Reactivation Date2020-02-19

NDC 51128-502-02 [51128050202]

MONTELUKAST TABLET, CHEWABLE
Marketing CategoryANDA
Application NumberANDA203037
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-12-01
Inactivation Date2020-01-31
Reactivation Date2020-02-19

Drug Details

Active Ingredients

IngredientStrength
MONTELUKAST SODIUM4 mg/1

OpenFDA Data

SPL SET ID:8216e292-2a06-4de0-bcb6-d282eb61d302
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 200224
  • 311759
  • 242438
  • UPC Code
  • 0351128503011
  • 0351128502014
  • 0351128501017
  • Pharmacological Class

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

    NDC Crossover Matching brand name "MONTELUKAST" or generic name "Montelukast"

    NDCBrand NameGeneric Name
    0143-9649MONTELUKASTMONTELUKAST
    0143-9650MONTELUKASTMONTELUKAST
    0143-9651MONTELUKASTMONTELUKAST
    0781-5554MontelukastMontelukast
    0781-5555MontelukastMontelukast
    0781-5560MontelukastMontelukast
    0904-6808MontelukastMontelukast
    31722-726MontelukastMontelukast
    33342-102MontelukastMontelukast
    50090-6108MontelukastMontelukast
    50268-556MontelukastMontelukast
    51128-501MONTELUKASTMONTELUKAST
    51128-502MONTELUKASTMONTELUKAST
    51128-503MONTELUKASTMONTELUKAST
    54458-890MontelukastMontelukast
    55154-8075MontelukastMontelukast
    63187-626MONTELUKASTMONTELUKAST
    63629-4886MontelukastMontelukast
    68001-361MontelukastMontelukast
    68071-1652MONTELUKASTMONTELUKAST
    68071-4034MontelukastMontelukast
    68645-560MontelukastMontelukast
    68788-7387MONTELUKASTMONTELUKAST
    69452-105MONTELUKASTMONTELUKAST
    69452-107MONTELUKASTMONTELUKAST
    69452-106MONTELUKASTMONTELUKAST
    70518-1031MontelukastMontelukast
    70518-2603MontelukastMontelukast
    27241-017MONTELUKAST SODIUMMONTELUKAST
    53217-357MONTELUKAST SODIUMMONTELUKAST

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