NDC 63187-876

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 Proficient Rx Lp. The primary component is Levalbuterol Tartrate.

• Product ID: 63187-876_7f787162-c522-4f7d-a095-ff8bc08de591
• NDC: 63187-876
• 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: 2016-10-01
• Marketing Category: NDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
• Application Number: NDA021730
• Labeler Name: Proficient Rx LP
• 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: 2019-12-31

Packaging

NDC 63187-876-15

1 INHALER in 1 CARTON (63187-876-15) > 200 AEROSOL, METERED in 1 INHALER

• Marketing Start Date: 2017-08-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 63187-876-15 [63187087615]

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: 2017-08-01

Drug Details

Active Ingredients

Ingredient	Strength
LEVALBUTEROL TARTRATE	45 ug/1

OpenFDA Data

• SPL SET ID: a469689a-e64e-4117-b94a-c8b730abda1a
• Manufacturer:
  • Proficient Rx LP
• 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