NDC 35573-443

Levalbuterol

Levalbuterol Hydrochloride

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

Product ID35573-443_055db544-4c08-4142-ba8e-88fbe0364c54
NDC35573-443
Product TypeHuman Prescription Drug
Proprietary NameLevalbuterol
Generic NameLevalbuterol Hydrochloride
Dosage FormSolution
Route of AdministrationRESPIRATORY (INHALATION)
Marketing Start Date2021-04-01
Marketing CategoryANDA /
Application NumberANDA203653
Labeler NameBurel Pharmaceuticals, Inc.
Substance NameLEVALBUTEROL HYDROCHLORIDE
Active Ingredient Strength0 mg/3mL
Pharm ClassesAdrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 35573-443-25

25 POUCH in 1 CARTON (35573-443-25) > 25 VIAL, SINGLE-DOSE in 1 POUCH > 3 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2021-04-01
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "Levalbuterol" or generic name "Levalbuterol Hydrochloride"

NDCBrand NameGeneric Name
0093-4145LevalbuterolLevalbuterol
0093-4146LevalbuterolLevalbuterol
0093-4147LevalbuterolLevalbuterol
0093-4148LevalbuterolLevalbuterol
0115-9930LevalbuterolLevalbuterol Hydrochloride
0115-9931LevalbuterolLevalbuterol Hydrochloride
0115-9932LevalbuterolLevalbuterol Hydrochloride
0378-6993Levalbuterollevalbuterol
0378-9680Levalbuterollevalbuterol
0378-9681Levalbuterollevalbuterol
0378-9682Levalbuterollevalbuterol
0378-9690LevalbuterolLevalbuterol
0378-9691LevalbuterolLevalbuterol
0378-9692LevalbuterolLevalbuterol
68788-6777LevalbuterolLevalbuterol
76204-900LevalbuterolLevalbuterol
76204-800LevalbuterolLevalbuterol
76204-700LevalbuterolLevalbuterol
63187-953LevalbuterolLevalbuterol
65862-944LevalbuterolLevalbuterol
65862-942LEVALBUTEROLLEVALBUTEROL
65862-945LevalbuterolLevalbuterol
65862-943LevalbuterolLevalbuterol
68071-5027LevalbuterolLevalbuterol
68071-2340LevalbuterolLevalbuterol
17478-171XopenexLevalbuterol Hydrochloride
17478-172XopenexLevalbuterol Hydrochloride
17478-173XopenexLevalbuterol Hydrochloride
17478-174XopenexLevalbuterol Hydrochloride
21695-153Xopenexlevalbuterol hydrochloride
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