NDC 52959-978

PROAIRHFA HFA

Albuterol Sulfate

PROAIRHFA HFA is a Respiratory (inhalation) Aerosol, Metered in the Human Prescription Drug category. It is labeled and distributed by H.j. Harkins Company, Inc.. The primary component is Albuterol Sulfate.

• Product ID: 52959-978_f3f4a975-d44b-4a91-af1a-b660b1ebb06a
• NDC: 52959-978
• Product Type: Human Prescription Drug
• Proprietary Name: PROAIRHFA HFA
• Generic Name: Albuterol Sulfate
• Dosage Form: Aerosol, Metered
• Route of Administration: RESPIRATORY (INHALATION)
• Marketing Start Date: 2004-12-01
• Marketing Category: NDA / NDA
• Application Number: NDA021457
• Labeler Name: H.J. Harkins Company, Inc.
• Substance Name: ALBUTEROL SULFATE
• Active Ingredient Strength: 90 ug/1
• Pharm Classes: Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 52959-978-01

200 AEROSOL, METERED in 1 INHALER (52959-978-01)

• Marketing Start Date: 2004-12-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 52959-978-01 [52959097801]

PROAIRHFA HFA AEROSOL, METERED

• Marketing Category: NDA
• Application Number: NDA021457
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2004-12-01
• Inactivation Date: 2019-11-13

Drug Details

Active Ingredients

Ingredient	Strength
ALBUTEROL SULFATE	90 ug/1

OpenFDA Data

• SPL SET ID: 22367ff1-5edf-429a-955a-728e42695f60
• Manufacturer:
  • H.J. Harkins Company, Inc.
• UNII:
  • 021SEF3731
• RxNorm Concept Unique ID - RxCUI:
  • 745752
  • 745679

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
52959-978	PROAIRHFA HFA	PROAIRHFA HFA
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