NDC 0037-0678

Gastrocrom

Cromolyn Sodium

Gastrocrom is a Oral Liquid in the Human Prescription Drug category. It is labeled and distributed by Meda Pharmaceuticals. The primary component is Cromolyn Sodium.

Product ID0037-0678_6c00dfda-8bd6-4f4e-a2fc-8b544c8b38d4
NDC0037-0678
Product TypeHuman Prescription Drug
Proprietary NameGastrocrom
Generic NameCromolyn Sodium
Dosage FormLiquid
Route of AdministrationORAL
Marketing Start Date2015-05-01
Marketing CategoryNDA / NDA
Application NumberNDA020479
Labeler NameMeda Pharmaceuticals
Substance NameCROMOLYN SODIUM
Active Ingredient Strength20 mg/mL
Pharm ClassesDecreased Histamine Release [PE],Mast Cell Stabilizer [EPC]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 0037-0678-96

12 POUCH in 1 CARTON (0037-0678-96) > 8 AMPULE in 1 POUCH (0037-0678-08) > 5 mL in 1 AMPULE
Marketing Start Date2015-05-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0037-0678-96 [00037067896]

Gastrocrom LIQUID
Marketing CategoryNDA
Application NumberNDA020479
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2015-05-01

NDC 0037-0678-08 [00037067808]

Gastrocrom LIQUID
Marketing CategoryNDA
Application NumberNDA020479
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2015-05-01

Drug Details

Active Ingredients

IngredientStrength
CROMOLYN SODIUM20 mg/mL

OpenFDA Data

SPL SET ID:00623958-a8fe-47d1-a0d2-0aa4e2f7966e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 831269
  • 831261

    • Pharmacological Class

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

    NDC Crossover Matching brand name "Gastrocrom" or generic name "Cromolyn Sodium"

    NDCBrand NameGeneric Name
    0037-0678Gastrocromcromolyn sodium
    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
    48102-033Cromolyn Sodium Inhalationcromolyn sodium
    60940-032Cromolyn Sodium Inhalation SolutionCromolyn Sodium
    52183-199NasalCromcromolyn sodium

    Trademark Results [Gastrocrom]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    GASTROCROM
    GASTROCROM
    87327236 5280608 Live/Registered
    Meda Pharma S.A.R.L.
    2017-02-07
    GASTROCROM
    GASTROCROM
    73256531 1173875 Dead/Cancelled
    Fisons Limited
    1980-04-03
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