NDC 69784-200

CROMOLYN SODIUM

Cromolyn Sodium

CROMOLYN SODIUM is a Oral Solution, Concentrate in the Human Prescription Drug category. It is labeled and distributed by Woodward Pharma Services Llc. The primary component is Cromolyn Sodium.

Product ID69784-200_40a4a9e8-3853-4097-85ff-3774a0718f7c
NDC69784-200
Product TypeHuman Prescription Drug
Proprietary NameCROMOLYN SODIUM
Generic NameCromolyn Sodium
Dosage FormSolution, Concentrate
Route of AdministrationORAL
Marketing Start Date2017-10-16
Marketing CategoryANDA / ANDA
Application NumberANDA209264
Labeler NameWoodward Pharma Services LLC
Substance NameCROMOLYN SODIUM
Active Ingredient Strength100 mg/5mL
Pharm ClassesDecreased Histamine Release [PE],Mast Cell Stabilizer [EPC]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 69784-200-96

12 POUCH in 1 CARTON (69784-200-96) > 8 AMPULE in 1 POUCH > 5 mL in 1 AMPULE
Marketing Start Date2017-10-16
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69784-200-08 [69784020008]

CROMOLYN SODIUM SOLUTION, CONCENTRATE
Marketing CategoryANDA
Application NumberANDA209264
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-10-16
Marketing End Date2018-02-07

NDC 69784-200-96 [69784020096]

CROMOLYN SODIUM SOLUTION, CONCENTRATE
Marketing CategoryANDA
Application NumberANDA209264
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2017-10-16

Drug Details

Active Ingredients

IngredientStrength
CROMOLYN SODIUM100 mg/5mL

OpenFDA Data

SPL SET ID:6be24bee-c252-49d3-8352-399ad8394f2d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 831261

    • Pharmacological Class

    • Decreased Histamine Release [PE]
    • Mast Cell Stabilizer [EPC]

    Medicade Reported Pricing

    69784020096 CROMOLYN 100 MG/5 ML ORAL CONC

    Pricing Unit: ML | Drug Type:

    NDC Crossover Matching brand name "CROMOLYN SODIUM" or generic name "Cromolyn Sodium"

    NDCBrand NameGeneric Name
    0172-6406Cromolyn SodiumCromolyn Sodium
    0904-5532Cromolyn SodiumCromolyn Sodium
    16571-600CROMOLYN SODIUMCROMOLYN SODIUM
    17478-291Cromolyn SodiumCromolyn Sodium
    37205-223Cromolyn SodiumCromolyn Sodium
    42571-132CROMOLYN SODIUMCromolyn sodium
    42571-350Cromolyn SodiumCromolyn Sodium
    50090-1202Cromolyn SodiumCromolyn Sodium
    50090-3042Cromolyn SodiumCromolyn Sodium
    50090-3125Cromolyn Sodiumcromolyn sodium
    51525-0470cromolyn sodiumcromolyn sodium
    53002-0140Cromolyn SodiumCromolyn Sodium
    57782-397Cromolyn SodiumCromolyn Sodium
    59779-075Cromolyn SodiumCromolyn Sodium
    61314-237Cromolyn SodiumCromolyn Sodium
    63187-473Cromolyn Sodiumcromolyn sodium
    63629-2483CROMOLYN SODIUMCROMOLYN SODIUM
    68071-3231Cromolyn SodiumCromolyn Sodium
    69784-200CROMOLYN SODIUMCROMOLYN SODIUM
    69784-205Cromolyn SodiumCromolyn Sodium
    70556-101CROMOLYN SODIUMCROMOLYN SODIUM
    70556-102Cromolyn SodiumCromolyn Sodium
    71205-085Cromolyn SodiumCromolyn Sodium
    71205-230Cromolyn SodiumCromolyn Sodium
    48102-033Cromolyn Sodium Inhalationcromolyn sodium
    60940-032Cromolyn Sodium Inhalation SolutionCromolyn Sodium
    0037-0678Gastrocromcromolyn sodium
    52183-199NasalCromcromolyn sodium
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.