NDC 59310-117

ProAir Digihaler

Albuterol Sulfate

ProAir Digihaler is a Respiratory (inhalation) Inhalant in the Human Prescription Drug category. It is labeled and distributed by Teva Respiratory, Llc. The primary component is Albuterol Sulfate.

Product ID59310-117_1f3216ea-911a-4226-a22c-2d91826a3b8d
NDC59310-117
Product TypeHuman Prescription Drug
Proprietary NameProAir Digihaler
Generic NameAlbuterol Sulfate
Dosage FormInhalant
Route of AdministrationRESPIRATORY (INHALATION)
Marketing Start Date2019-10-04
Marketing CategoryNDA / NDA
Application NumberNDA205636
Labeler NameTeva Respiratory, LLC
Substance NameALBUTEROL SULFATE
Active Ingredient Strength90 ug/1
Pharm ClassesAdrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 59310-117-20

1 INHALER in 1 BOX (59310-117-20) > 200 INHALANT in 1 INHALER
Marketing Start Date2019-10-04
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 59310-117-21 [59310011721]

ProAir Digihaler INHALANT
Marketing CategoryNDA
Application NumberNDA205636
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-10-04

NDC 59310-117-20 [59310011720]

ProAir Digihaler INHALANT
Marketing CategoryNDA
Application NumberNDA205636
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-10-04

Drug Details

Active Ingredients

IngredientStrength
ALBUTEROL SULFATE90 ug/1

Pharmacological Class

  • Adrenergic beta2-Agonists [MoA]
  • beta2-Adrenergic Agonist [EPC]

NDC Crossover Matching brand name "ProAir Digihaler" or generic name "Albuterol Sulfate"

NDCBrand NameGeneric Name
59310-117ProAir DigihalerProAir Digihaler
59310-540ProAir DigihalerProAir Digihaler
0378-0255Albuterolalbuterol sulfate
0378-0572Albuterolalbuterol sulfate
0054-0742Albuterol SulfateAlbuterol 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
0378-7057Albuterol SulfateAlbuterol Sulfate
0378-7058Albuterol SulfateAlbuterol Sulfate
0378-8270Albuterol SulfateAlbuterol Sulfate
0085-1132Proventil HFAAlbuterol Sulfate
0173-0682VENTOLINalbuterol sulfate

Trademark Results [ProAir Digihaler]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PROAIR DIGIHALER
PROAIR DIGIHALER
88836810 not registered Live/Pending
Teva Respiratory, LLC
2020-03-17
PROAIR DIGIHALER
PROAIR DIGIHALER
88820728 not registered Live/Pending
Teva Respiratory, LLC
2020-03-04
PROAIR DIGIHALER
PROAIR DIGIHALER
88284201 not registered Live/Pending
Teva Respiratory, LLC
2019-01-31
PROAIR DIGIHALER
PROAIR DIGIHALER
88284199 not registered Live/Pending
Teva Respiratory, LLC
2019-01-31
PROAIR DIGIHALER
PROAIR DIGIHALER
88284196 not registered Live/Pending
Teva Respiratory, LLC
2019-01-31
PROAIR DIGIHALER
PROAIR DIGIHALER
87147693 not registered Live/Pending
Teva Respiratory, LLC
2016-08-23
PROAIR DIGIHALER
PROAIR DIGIHALER
87147689 5932346 Live/Registered
Teva Respiratory, LLC
2016-08-23
PROAIR DIGIHALER
PROAIR DIGIHALER
87147684 not registered Live/Pending
Teva Respiratory, LLC
2016-08-23

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