NDC 63629-8814

Formoterol fumarate

Formoterol Fumarate

Formoterol fumarate is a Respiratory (inhalation) Solution in the Human Prescription Drug category. It is labeled and distributed by Bryant Ranch Prepack. The primary component is Formoterol Fumarate.

Product ID63629-8814_47cd1846-a298-4541-b2f3-2a54846bc8ba
NDC63629-8814
Product TypeHuman Prescription Drug
Proprietary NameFormoterol fumarate
Generic NameFormoterol Fumarate
Dosage FormSolution
Route of AdministrationRESPIRATORY (INHALATION)
Marketing Start Date2021-06-22
Marketing CategoryANDA /
Application NumberANDA091141
Labeler NameBryant Ranch Prepack
Substance NameFORMOTEROL FUMARATE
Active Ingredient Strength20 ug/2mL
Pharm ClassesAdrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 63629-8814-1

60 POUCH in 1 CARTON (63629-8814-1) > 1 VIAL in 1 POUCH > 2 mL in 1 VIAL
Marketing Start Date2021-09-10
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "Formoterol fumarate" or generic name "Formoterol Fumarate"

NDCBrand NameGeneric Name
0093-4061Formoterol fumarateFormoterol fumarate
0378-1631FORMOTEROL FUMARATEformoterol fumarate dihydrate
62332-655Formoterol FumarateFormoterol Fumarate
63629-8813Formoterol fumarateFormoterol fumarate
63629-8814Formoterol fumarateFormoterol fumarate
70748-261formoterol fumarateformoterol fumarate
73289-0060Formoterol Fumarateformoterol fumarate dihydrate

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