NDC 0781-5555

Montelukast

Montelukast

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

Product ID0781-5555_419ac695-fc60-4b5b-ab3e-36820c60729b
NDC0781-5555
Product TypeHuman Prescription Drug
Proprietary NameMontelukast
Generic NameMontelukast
Dosage FormTablet, Chewable
Route of AdministrationORAL
Marketing Start Date2012-08-03
Marketing CategoryANDA / ANDA
Application NumberANDA091414
Labeler NameSandoz Inc
Substance NameMONTELUKAST SODIUM
Active Ingredient Strength5 mg/1
Pharm ClassesLeukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0781-5555-05

500 TABLET, CHEWABLE in 1 BOTTLE (0781-5555-05)
Marketing Start Date2012-08-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0781-5555-92 [00781555592]

Montelukast TABLET, CHEWABLE
Marketing CategoryANDA
Application NumberANDA091414
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-08-03

NDC 0781-5555-31 [00781555531]

Montelukast TABLET, CHEWABLE
Marketing CategoryANDA
Application NumberANDA091414
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-08-03

NDC 0781-5555-05 [00781555505]

Montelukast TABLET, CHEWABLE
Marketing CategoryANDA
Application NumberANDA091414
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-08-03

NDC 0781-5555-13 [00781555513]

Montelukast TABLET, CHEWABLE
Marketing CategoryANDA
Application NumberANDA091414
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-08-03

NDC 0781-5555-06 [00781555506]

Montelukast TABLET, CHEWABLE
Marketing CategoryANDA
Application NumberANDA091414
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-08-03

NDC 0781-5555-64 [00781555564]

Montelukast TABLET, CHEWABLE
Marketing CategoryANDA
Application NumberANDA091414
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-08-03

Drug Details

Active Ingredients

IngredientStrength
MONTELUKAST SODIUM5 mg/1

OpenFDA Data

SPL SET ID:6d69e73a-76cb-4ece-9cf9-e9adb4f523b4
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 200224
  • 311759
  • 242438
    • UPC Code
  • 0307815554316
  • 0307815560317
  • 0307815555313

    • 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
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.