NDC 68258-3033

SINGULAIR

Montelukast Sodium

SINGULAIR is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Dispensing Solutions Inc.. The primary component is Montelukast Sodium.

Product ID68258-3033_6f5962a5-487d-4d7d-a3eb-ec9d1e77caca
NDC68258-3033
Product TypeHuman Prescription Drug
Proprietary NameSINGULAIR
Generic NameMontelukast Sodium
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2009-10-08
Marketing CategoryNDA / NDA
Application NumberNDA020829
Labeler NameDispensing Solutions Inc.
Substance NameMONTELUKAST SODIUM
Active Ingredient Strength10 mg/1
Pharm ClassesLeukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 68258-3033-3

30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68258-3033-3)
Marketing Start Date2009-10-08
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68258-3033-3 [68258303303]

SINGULAIR TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA020829
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-10-08
Inactivation Date2019-10-21

Drug Details

Active Ingredients

IngredientStrength
MONTELUKAST SODIUM10 mg/1

OpenFDA Data

SPL SET ID:10cd5ca5-6f8b-417c-af11-a2054a2dde34
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 200224
  • 153892
  • 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
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