NDC 47335-743

Levalbuterol Inhalation Solution

Levalbuterol Inhalation Solution

Levalbuterol Inhalation Solution is a Respiratory (inhalation) Solution in the Human Prescription Drug category. It is labeled and distributed by Sun Pharmaceutical Industries, Inc.. The primary component is Levalbuterol Hydrochloride.

Product ID47335-743_927ff610-9e74-442d-9144-21d5e06cf0a0
NDC47335-743
Product TypeHuman Prescription Drug
Proprietary NameLevalbuterol Inhalation Solution
Generic NameLevalbuterol Inhalation Solution
Dosage FormSolution
Route of AdministrationRESPIRATORY (INHALATION)
Marketing Start Date2018-12-01
Marketing CategoryANDA / ANDA
Application NumberANDA207820
Labeler NameSun Pharmaceutical Industries, Inc.
Substance NameLEVALBUTEROL HYDROCHLORIDE
Active Ingredient Strength0 mg/3mL
Pharm ClassesAdrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 47335-743-01

5 POUCH in 1 CARTON (47335-743-01) > 5 VIAL, SINGLE-DOSE in 1 POUCH > 3 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2020-07-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 47335-743-52 [47335074352]

Levalbuterol Inhalation Solution SOLUTION
Marketing CategoryANDA
Application NumberANDA207820
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-12-01

NDC 47335-743-49 [47335074349]

Levalbuterol Inhalation Solution SOLUTION
Marketing CategoryANDA
Application NumberANDA207820
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-12-01

NDC 47335-743-51 [47335074351]

Levalbuterol Inhalation Solution SOLUTION
Marketing CategoryANDA
Application NumberANDA207820
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-12-01
Marketing End Date2020-04-30

NDC 47335-743-48 [47335074348]

Levalbuterol Inhalation Solution SOLUTION
Marketing CategoryANDA
Application NumberANDA207820
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-12-01
Marketing End Date2020-04-30

Drug Details

Active Ingredients

IngredientStrength
LEVALBUTEROL HYDROCHLORIDE.31 mg/3mL

OpenFDA Data

SPL SET ID:85a59e0c-ff09-49a6-b7b8-616e033107b4
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 311286
  • 349590
  • 242754
  • Pharmacological Class

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

    NDC Crossover Matching brand name "Levalbuterol Inhalation Solution" or generic name "Levalbuterol Inhalation Solution"

    NDCBrand NameGeneric Name
    16714-094Levalbuterol Inhalation SolutionLevalbuterol Inhalation Solution
    16714-095Levalbuterol Inhalation SolutionLevalbuterol Inhalation Solution
    16714-096Levalbuterol Inhalation SolutionLevalbuterol Inhalation Solution
    47335-743Levalbuterol Inhalation SolutionLevalbuterol Inhalation Solution
    47335-746Levalbuterol Inhalation SolutionLevalbuterol Inhalation Solution
    47335-753Levalbuterol Inhalation SolutionLevalbuterol Inhalation Solution

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