NDC 70556-101

CROMOLYN SODIUM

Cromolyn Sodium

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

Product ID70556-101_088d1cec-4377-4a59-8c4e-f04cac40eea5
NDC70556-101
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 NameAilex Pharmaceuticals, LLC
Substance NameCROMOLYN SODIUM
Active Ingredient Strength100 mg/5mL
Pharm ClassesDecreased Histamine Release [PE],Mast Cell Stabilizer [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 70556-101-96

12 POUCH in 1 CARTON (70556-101-96) > 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 70556-101-96 [70556010196]

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

Drug Details

Active Ingredients

IngredientStrength
CROMOLYN SODIUM100 mg/5mL

OpenFDA Data

SPL SET ID:7143e897-03d2-4ef9-b95a-3d43f971b3bd
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 831261
  • Pharmacological Class

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

    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

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.