NDC 0186-0370

SYMBICORT

Budesonide And Formoterol Fumarate Dihydrate

SYMBICORT is a Respiratory (inhalation) Aerosol in the Human Prescription Drug category. It is labeled and distributed by Astrazeneca Pharmaceuticals Lp. The primary component is Budesonide; Formoterol Fumarate.

Product ID0186-0370_5b03fd09-2533-4975-88da-a0b9c8495d1e
NDC0186-0370
Product TypeHuman Prescription Drug
Proprietary NameSYMBICORT
Generic NameBudesonide And Formoterol Fumarate Dihydrate
Dosage FormAerosol
Route of AdministrationRESPIRATORY (INHALATION)
Marketing Start Date2007-05-29
Marketing CategoryNDA / NDA
Application NumberNDA021929
Labeler NameAstraZeneca Pharmaceuticals LP
Substance NameBUDESONIDE; FORMOTEROL FUMARATE
Active Ingredient Strength160 ug/1; ug/1
Pharm ClassesCorticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0186-0370-20

1 POUCH in 1 CARTON (0186-0370-20) > 1 CANISTER in 1 POUCH > 120 AEROSOL in 1 CANISTER
Marketing Start Date2007-05-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0186-0370-28 [00186037028]

SYMBICORT AEROSOL
Marketing CategoryNDA
Application NumberNDA021929
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2007-09-06

NDC 0186-0370-20 [00186037020]

SYMBICORT AEROSOL
Marketing CategoryNDA
Application NumberNDA021929
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2007-05-29

NDC 0186-0370-60 [00186037060]

SYMBICORT AEROSOL
Marketing CategoryNDA
Application NumberNDA021929
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-09-06

Drug Details

Active Ingredients

IngredientStrength
BUDESONIDE160 ug/1

OpenFDA Data

SPL SET ID:fafa4cf1-99c2-43d5-73ad-51f256de3be0
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1246290
  • 1246288
  • 1246304
  • 1246306
  • 1246316
  • 1246317
  • 1246314
  • 1246315
  • Pharmacological Class

    • Corticosteroid [EPC]
    • Corticosteroid Hormone Receptor Agonists [MoA]
    • Adrenergic beta2-Agonists [MoA]
    • beta2-Adrenergic Agonist [EPC]

    NDC Crossover Matching brand name "SYMBICORT" or generic name "Budesonide And Formoterol Fumarate Dihydrate"

    NDCBrand NameGeneric Name
    0186-0370SYMBICORTBudesonide and Formoterol Fumarate Dihydrate
    0186-0372SYMBICORTBudesonide and Formoterol Fumarate Dihydrate
    50090-1403SYMBICORTBudesonide and Formoterol Fumarate Dihydrate
    70518-2696SYMBICORTBudesonide and Formoterol Fumarate Dihydrate
    0310-7370Budesonide and Formoterol Fumarate DihydrateBudesonide and Formoterol Fumarate Dihydrate
    0310-7372Budesonide and Formoterol Fumarate DihydrateBudesonide and Formoterol Fumarate Dihydrate
    53002-2666Budesonide and Formoterol Fumarate DihydrateBudesonide and Formoterol Fumarate Dihydrate
    53002-2667Budesonide and Formoterol Fumarate DihydrateBudesonide and Formoterol Fumarate Dihydrate
    70518-3107Budesonide and Formoterol Fumarate DihydrateBudesonide and Formoterol Fumarate Dihydrate

    Trademark Results [SYMBICORT]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    SYMBICORT
    SYMBICORT
    78798384 not registered Dead/Abandoned
    AstraZeneca AB
    2006-01-24
    SYMBICORT
    SYMBICORT
    76191436 2567090 Live/Registered
    AstraZeneca AB
    2001-01-08
    SYMBICORT
    SYMBICORT
    74497859 1885787 Dead/Cancelled
    AKTIEBOLAGET ASTRA
    1994-03-07
    SYMBICORT
    SYMBICORT
    74285663 not registered Dead/Abandoned
    AKTIEBOLAGET ASTRA
    1992-06-17

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