NDC 0591-2927

Levalbuterol tartrate HFA inhalation

Levalbuterol Tartrate

Levalbuterol tartrate HFA inhalation is a Oral Aerosol, Metered in the Human Prescription Drug category. It is labeled and distributed by Actavis Pharma, Inc.. The primary component is Levalbuterol Tartrate.

• Product ID: 0591-2927_47ae9104-0a80-4c9a-a2ed-24c8845bb333
• NDC: 0591-2927
• Product Type: Human Prescription Drug
• Proprietary Name: Levalbuterol tartrate HFA inhalation
• Generic Name: Levalbuterol Tartrate
• Dosage Form: Aerosol, Metered
• Route of Administration: ORAL
• Marketing Start Date: 2016-10-03
• Marketing Category: NDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
• Application Number: NDA021730
• Labeler Name: Actavis Pharma, Inc.
• Substance Name: LEVALBUTEROL TARTRATE
• Active Ingredient Strength: 45 ug/1
• Pharm Classes: Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0591-2927-54

1 INHALER in 1 CARTON (0591-2927-54) > 200 AEROSOL, METERED in 1 INHALER

• Marketing Start Date: 2016-10-03
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0591-2927-54 [00591292754]

Levalbuterol tartrate HFA inhalation AEROSOL, METERED

• Marketing Category: NDA AUTHORIZED GENERIC
• Application Number: NDA021730
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2016-10-03

Drug Details

Active Ingredients

Ingredient	Strength
LEVALBUTEROL TARTRATE	45 ug/1

OpenFDA Data

• SPL SET ID: ac85703a-17a2-4f0b-87f4-78f1756d2f85
• Manufacturer:
  • Actavis Pharma, Inc.
• UNII:
  • ADS4I3E22M
• RxNorm Concept Unique ID - RxCUI:
  • 745791

Pharmacological Class

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

NDC Crossover Matching brand name "Levalbuterol tartrate HFA inhalation" or generic name "Levalbuterol Tartrate"

NDC	Brand Name	Generic Name
0591-2927	Levalbuterol tartrate HFA inhalation	levalbuterol tartrate
63187-876	Levalbuterol tartrate HFA inhalation	levalbuterol tartrate
63629-8822	Levalbuterol tartrate HFA inhalation	levalbuterol tartrate
68788-6845	Levalbuterol tartrate HFA inhalation	levalbuterol tartrate
63402-510	Xopenex HFA	levalbuterol tartrate