NDC 0378-9680

Levalbuterol

Levalbuterol

Levalbuterol is a Respiratory (inhalation) Solution in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Levalbuterol Hydrochloride.

Product ID0378-9680_111e97b2-4366-4552-8bf8-c2f944fd317e
NDC0378-9680
Product TypeHuman Prescription Drug
Proprietary NameLevalbuterol
Generic NameLevalbuterol
Dosage FormSolution
Route of AdministrationRESPIRATORY (INHALATION)
Marketing Start Date2013-03-15
Marketing End Date2019-08-31
Marketing CategoryANDA / ANDA
Application NumberANDA077800
Labeler NameMylan Pharmaceuticals Inc.
Substance NameLEVALBUTEROL HYDROCHLORIDE
Active Ingredient Strength0 mg/3mL
Pharm ClassesAdrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]
NDC Exclude FlagN

Packaging

NDC 0378-9680-44

2 POUCH in 1 CARTON (0378-9680-44) > 12 VIAL in 1 POUCH (0378-9680-96) > 3 mL in 1 VIAL
Marketing Start Date2013-03-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-9680-96 [00378968096]

Levalbuterol SOLUTION
Marketing CategoryANDA
Application NumberANDA077800
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2013-03-15
Marketing End Date2019-08-31

NDC 0378-9680-44 [00378968044]

Levalbuterol SOLUTION
Marketing CategoryANDA
Application NumberANDA077800
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2013-03-15
Marketing End Date2019-08-31

Drug Details

Active Ingredients

IngredientStrength
LEVALBUTEROL HYDROCHLORIDE.31 mg/3mL

OpenFDA Data

SPL SET ID:322c7883-f01b-4ce9-b667-4924717a4e6c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 311286
  • 349590
  • 242754

    • Pharmacological Class

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