NDC 61314-237

Cromolyn Sodium

Cromolyn Sodium

Cromolyn Sodium is a Ophthalmic Solution/ Drops in the Human Prescription Drug category. It is labeled and distributed by Sandoz Inc. The primary component is Cromolyn Sodium.

Product ID61314-237_39318164-99b0-42a8-b572-d8ee1fe3e764
NDC61314-237
Product TypeHuman Prescription Drug
Proprietary NameCromolyn Sodium
Generic NameCromolyn Sodium
Dosage FormSolution/ Drops
Route of AdministrationOPHTHALMIC
Marketing Start Date1999-06-29
Marketing CategoryANDA / ANDA
Application NumberANDA075282
Labeler NameSandoz Inc
Substance NameCROMOLYN SODIUM
Active Ingredient Strength40 mg/mL
Pharm ClassesDecreased Histamine Release [PE],Mast Cell Stabilizer [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 61314-237-10

10 mL in 1 BOTTLE, PLASTIC (61314-237-10)
Marketing Start Date1999-06-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 61314-237-10 [61314023710]

Cromolyn Sodium SOLUTION/ DROPS
Marketing CategoryANDA
Application NumberANDA075282
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1999-06-29

NDC 61314-237-15 [61314023715]

Cromolyn Sodium SOLUTION/ DROPS
Marketing CategoryANDA
Application NumberANDA075282
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1999-06-29
Marketing End Date2014-08-15

Drug Details

Active Ingredients

IngredientStrength
CROMOLYN SODIUM40 mg/mL

OpenFDA Data

SPL SET ID:b32851c3-cd97-4be4-a09c-1deab1d6966b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 831109
  • Pharmacological Class

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

    Medicade Reported Pricing

    61314023710 CROMOLYN 4% EYE DROPS

    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

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