NDC 16714-094

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 Northstar Rxllc. The primary component is Levalbuterol Hydrochloride.

Product ID16714-094_a60ea366-65a8-4559-9af5-5afd97875d2e
NDC16714-094
Product TypeHuman Prescription Drug
Proprietary NameLevalbuterol Inhalation Solution
Generic NameLevalbuterol Inhalation Solution
Dosage FormSolution
Route of AdministrationRESPIRATORY (INHALATION)
Marketing Start Date2020-05-05
Marketing CategoryANDA / ANDA
Application NumberANDA207820
Labeler NameNorthStar RxLLC
Substance NameLEVALBUTEROL HYDROCHLORIDE
Active Ingredient Strength0 mg/3mL
Pharm ClassesAdrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 16714-094-25

5 POUCH in 1 CARTON (16714-094-25) > 5 VIAL, SINGLE-DOSE in 1 POUCH > 3 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2020-05-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 16714-094-30 [16714009430]

Levalbuterol Inhalation Solution SOLUTION
Marketing CategoryANDA
Application NumberANDA207820
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-05-05

NDC 16714-094-25 [16714009425]

Levalbuterol Inhalation Solution SOLUTION
Marketing CategoryANDA
Application NumberANDA207820
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-05-05

Drug Details

Active Ingredients

IngredientStrength
LEVALBUTEROL HYDROCHLORIDE.31 mg/3mL

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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