NDC 66758-959

Proventil HFA

Albuterol Sulfate

Proventil HFA is a Respiratory (inhalation) Aerosol, Metered in the Human Prescription Drug category. It is labeled and distributed by Sandoz. The primary component is Albuterol Sulfate.

Product ID66758-959_c0e3057d-2dc4-de2b-e053-2995a90a1a1d
Product TypeHuman Prescription Drug
Proprietary NameProventil HFA
Generic NameAlbuterol Sulfate
Dosage FormAerosol, Metered
Route of AdministrationRESPIRATORY (INHALATION)
Marketing Start Date2021-05-04
Marketing CategoryNDA /
Application NumberNDA020503
Labeler NameSandoz
Active Ingredient Strength108 ug/1
Pharm ClassesAdrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]
NDC Exclude FlagN
Listing Certified Through2022-12-31


NDC 66758-959-85

1 CANISTER in 1 CARTON (66758-959-85) > 200 AEROSOL, METERED in 1 CANISTER
Marketing Start Date2021-05-04
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "Proventil HFA" or generic name "Albuterol Sulfate"

NDCBrand NameGeneric Name
0085-1132Proventil HFAAlbuterol Sulfate
42254-004Proventil HFAProventil HFA
50090-0624Proventil HFAProventil HFA
50090-4326Proventil HFAProventil HFA
0378-0255Albuterolalbuterol sulfate
0378-0572Albuterolalbuterol sulfate
0093-3174Albuterol SulfateAlbuterol Sulfate
0254-1007Albuterol SulfateAlbuterol Sulfate
0378-4122Albuterol Sulfatealbuterol sulfate
0378-4124Albuterol Sulfatealbuterol sulfate
0378-6991Albuterol Sulfatealbuterol sulfate
0378-6992Albuterol Sulfatealbuterol sulfate
0378-8270Albuterol SulfateAlbuterol Sulfate
0472-0825Albuterol SulfateAlbuterol Sulfate
0487-0301Albuterol SulfateAlbuterol Sulfate
0487-9501Albuterol SulfateAlbuterol Sulfate
0487-9901Albuterol SulfateAlbuterol Sulfate
0487-9904Albuterol SulfateAlbuterol Sulfate
0591-3467Albuterol SulfateAlbuterol Sulfate
0173-0682VENTOLINalbuterol sulfate

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.