Xopenex - 63402-515-30 - (levalbuterol hydrochloride)

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Drug Information of Xopenex

Product NDC: 63402-515
Proprietary Name: Xopenex
Non Proprietary Name: levalbuterol hydrochloride
Active Ingredient(s): 1.25    mg/.5mL & nbsp;   levalbuterol hydrochloride
Administration Route(s): RESPIRATORY (INHALATION)
Dosage Form(s): SOLUTION, CONCENTRATE
Coding System: National Drug Codes(NDC)

Labeler Information of Xopenex

Product NDC: 63402-515
Labeler Name: Sunovion Pharmaceuticals Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: NDA020837
Marketing Category: NDA
Start Marketing Date: 20040801

Package Information of Xopenex

Package NDC: 63402-515-30
Package Description: 30 POUCH in 1 CARTON (63402-515-30) > 1 VIAL, SINGLE-DOSE in 1 POUCH (63402-515-00) > .5 mL in 1 VIAL, SINGLE-DOSE

NDC Information of Xopenex

NDC Code 63402-515-30
Proprietary Name Xopenex
Package Description 30 POUCH in 1 CARTON (63402-515-30) > 1 VIAL, SINGLE-DOSE in 1 POUCH (63402-515-00) > .5 mL in 1 VIAL, SINGLE-DOSE
Product NDC 63402-515
Product Type Name HUMAN PRESCRIPTION DRUG
Non Proprietary Name levalbuterol hydrochloride
Dosage Form Name SOLUTION, CONCENTRATE
Route Name RESPIRATORY (INHALATION)
Start Marketing Date 20040801
Marketing Category Name NDA
Labeler Name Sunovion Pharmaceuticals Inc.
Substance Name LEVALBUTEROL HYDROCHLORIDE
Strength Number 1.25
Strength Unit mg/.5mL
Pharmaceutical Classes Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]

Complete Information of Xopenex


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