NDC 59310-540

ProAir Digihaler

Albuterol Sulfate

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

• Product ID: 59310-540_1f3216ea-911a-4226-a22c-2d91826a3b8d
• NDC: 59310-540
• Product Type: Human Prescription Drug
• Proprietary Name: ProAir Digihaler
• Generic Name: Albuterol Sulfate
• Dosage Form: Powder, Metered
• Route of Administration: RESPIRATORY (INHALATION)
• Marketing Start Date: 2019-10-04
• Marketing Category: NDA / NDA
• Application Number: NDA205636
• Labeler Name: Teva Respiratory, LLC
• Substance Name: ALBUTEROL SULFATE
• Active Ingredient Strength: 90 ug/1
• Pharm Classes: Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 59310-540-20

1 INHALER in 1 BOX (59310-540-20) > 200 POWDER, METERED in 1 INHALER

• Marketing Start Date: 2019-10-04
• NDC Exclude Flag: N
• Sample Package?: Y

NDC SPL Data Element Entries

NDC 59310-540-20 [59310054020]

ProAir Digihaler POWDER, METERED

• Marketing Category: NDA
• Application Number: NDA205636
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-10-04

NDC 59310-540-21 [59310054021]

ProAir Digihaler POWDER, METERED

• Marketing Category: NDA
• Application Number: NDA205636
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-10-04

Drug Details

Active Ingredients

Ingredient	Strength
ALBUTEROL SULFATE	90 ug/1

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
59310-117	ProAir Digihaler	ProAir Digihaler
59310-540	ProAir Digihaler	ProAir Digihaler
0378-0255	Albuterol	albuterol sulfate
0378-0572	Albuterol	albuterol sulfate
0054-0742	Albuterol Sulfate	Albuterol Sulfate
0093-3174	Albuterol Sulfate	Albuterol Sulfate
0254-1007	Albuterol Sulfate	Albuterol Sulfate
0378-4122	Albuterol Sulfate	albuterol sulfate
0378-4124	Albuterol Sulfate	albuterol sulfate
0378-6991	Albuterol Sulfate	albuterol sulfate
0378-6992	Albuterol Sulfate	albuterol sulfate
0378-7057	Albuterol Sulfate	Albuterol Sulfate
0378-7058	Albuterol Sulfate	Albuterol Sulfate
0378-8270	Albuterol Sulfate	Albuterol Sulfate
0085-1132	Proventil HFA	Albuterol Sulfate
0173-0682	VENTOLIN	albuterol sulfate