NDC 63629-3701

SINGULAIR

Montelukast Sodium

SINGULAIR is a Oral Tablet, Chewable in the Human Prescription Drug category. It is labeled and distributed by Bryant Ranch Prepack. The primary component is Montelukast Sodium.

Product ID63629-3701_a8054858-c322-4f42-ae25-127247706b57
NDC63629-3701
Product TypeHuman Prescription Drug
Proprietary NameSINGULAIR
Generic NameMontelukast Sodium
Dosage FormTablet, Chewable
Route of AdministrationORAL
Marketing Start Date1998-02-20
Marketing CategoryNDA / NDA
Application NumberNDA020830
Labeler NameBryant Ranch Prepack
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 63629-3701-1

1 TABLET, CHEWABLE in 1 BOTTLE (63629-3701-1)
Marketing Start Date1998-02-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63629-3701-1 [63629370101]

SINGULAIR TABLET, CHEWABLE
Marketing CategoryNDA
Application NumberNDA020830
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1998-02-20
Inactivation Date2019-11-27

Drug Details

Active Ingredients

IngredientStrength
MONTELUKAST SODIUM5 mg/1

OpenFDA Data

SPL SET ID:bb2ed030-851f-495c-adb6-8708c4b64f1b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 153893
  • 242438

    • Pharmacological Class

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

    NDC Crossover Matching brand name "SINGULAIR" or generic name "Montelukast Sodium"

    NDCBrand NameGeneric Name
    0006-1711SINGULAIRmontelukast sodium
    0006-3841SINGULAIRmontelukast sodium
    0006-9117SINGULAIRmontelukast sodium
    0006-9275SINGULAIRmontelukast sodium
    68258-3033SINGULAIRSINGULAIR
    68258-3032SINGULAIRSINGULAIR
    21695-221SINGULAIRSINGULAIR
    21695-565SINGULAIRSINGULAIR
    63629-2979SINGULAIRSINGULAIR
    63629-3701SINGULAIRSINGULAIR
    0054-0259Montelukast SodiumMontelukast Sodium
    0054-0288Montelukast SodiumMontelukast Sodium
    0054-0289Montelukast SodiumMontelukast Sodium
    0093-7424Montelukast SodiumMontelukast Sodium
    0093-7425Montelukast SodiumMontelukast Sodium

    Trademark Results [SINGULAIR]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    SINGULAIR
    SINGULAIR
    74589438 2048127 Live/Registered
    MERCK SHARP & DOHME CORP.
    1994-10-24
    SINGULAIR
    SINGULAIR
    73793956 1570791 Live/Registered
    NORWALK WASTEWATER EQUIPMENT COMPANY
    1989-04-17
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.