NDC 0310-7370

Budesonide and Formoterol Fumarate Dihydrate

Budesonide And Formoterol Fumarate Dihydrate

Budesonide and Formoterol Fumarate Dihydrate 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 ID0310-7370_1d266fe8-52e3-4f85-a037-c5c1afa15e60
NDC0310-7370
Product TypeHuman Prescription Drug
Proprietary NameBudesonide and Formoterol Fumarate Dihydrate
Generic NameBudesonide And Formoterol Fumarate Dihydrate
Dosage FormAerosol
Route of AdministrationRESPIRATORY (INHALATION)
Marketing Start Date2020-01-03
Marketing CategoryNDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
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 Through2021-12-31

Packaging

NDC 0310-7370-20

1 POUCH in 1 CARTON (0310-7370-20) > 1 CANISTER in 1 POUCH > 120 AEROSOL in 1 CANISTER
Marketing Start Date2020-01-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0310-7370-20 [00310737020]

Budesonide and Formoterol Fumarate Dihydrate AEROSOL
Marketing CategoryNDA authorized generic
Application NumberNDA021929
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2020-01-03

Drug Details

Active Ingredients

IngredientStrength
BUDESONIDE160 ug/1

Pharmacological Class

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

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

NDCBrand NameGeneric Name
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
0186-0370SYMBICORTBudesonide and Formoterol Fumarate Dihydrate
0186-0372SYMBICORTBudesonide and Formoterol Fumarate Dihydrate
50090-1403SYMBICORTBudesonide and Formoterol Fumarate Dihydrate
70518-2696SYMBICORTBudesonide and Formoterol Fumarate Dihydrate
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.