NDC 0143-9650

MONTELUKAST

Montelukast

MONTELUKAST is a Oral Tablet, Chewable in the Human Prescription Drug category. It is labeled and distributed by West Ward Pharmaceutical Corp. The primary component is Montelukast Sodium.

Product ID0143-9650_88edb668-e5cc-4bdc-8cb0-622ebed87063
NDC0143-9650
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 NameWest ward Pharmaceutical Corp
Substance NameMONTELUKAST SODIUM
Active Ingredient Strength5 mg/1
Pharm ClassesLeukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 0143-9650-30

30 TABLET, CHEWABLE in 1 BOTTLE (0143-9650-30)
Marketing Start Date2014-12-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0143-9650-30 [00143965030]

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

NDC 0143-9650-09 [00143965009]

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

NDC 0143-9650-10 [00143965010]

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

Drug Details

Active Ingredients

IngredientStrength
MONTELUKAST SODIUM5 mg/1

OpenFDA Data

SPL SET ID:43b80e54-bd48-46f0-835e-b055e797a8c0
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 200224
  • 311759
  • 242438
    • UPC Code
  • 0301439649304
  • 0301439651307
  • 0301439650300

    • 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
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