NDC 53002-2667

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 Rpk Pharmaceuticals, Inc.. The primary component is Budesonide; Formoterol Fumarate.

Product ID53002-2667_ed2f9421-5a02-4d2b-b1c0-6c1f4f03ed32
NDC53002-2667
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 NameRPK Pharmaceuticals, Inc.
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 53002-2667-1

1 POUCH in 1 CARTON (53002-2667-1) > 1 AEROSOL in 1 POUCH
Marketing Start Date2020-01-03
NDC Exclude FlagN
Sample Package?N

Drug Details

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
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