Levalbuterol hydrochloride solution

Ingredients and appearance - Product information

Levalbuterol hydrochloride solution- Levalbuterol hydrochloride

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 0591-2918
Route of Administration Respiratory (inhalation)

Active Ingredient/Active Moiety

Ingredient Name Strength
Levalbuterol hydrochloride ( UNII: WDQ1526QJM)( Levalbuterol - UNII: EDN2NBH5SS ) 0.31 mgin 3 mL

Inactive Ingredients

Ingredient Name Code
Sodium chloride ( UNII: 451W47IQ8X)
Sulfuric acid ( UNII: O40UQP6WCF)
Water ( UNII: 059QF0KO0R)
Nitrogen ( UNII: N762921K75)

Product Characteristics

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
NDA NDA020837 USA

Levalbuterol hydrochloride solution- Levalbuterol hydrochloride

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 0591-2919
Route of Administration Respiratory (inhalation)

Active Ingredient/Active Moiety

Ingredient Name Strength
Levalbuterol hydrochloride ( UNII: WDQ1526QJM)( Levalbuterol - UNII: EDN2NBH5SS ) 0.63 mgin 3 mL

Inactive Ingredients

Ingredient Name Code
Sodium chloride ( UNII: 451W47IQ8X)
Sulfuric acid ( UNII: O40UQP6WCF)
Water ( UNII: 059QF0KO0R)
Nitrogen ( UNII: N762921K75)

Product Characteristics

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
NDA NDA020837 USA

Levalbuterol hydrochloride solution- Levalbuterol hydrochloride

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 0591-2920
Route of Administration Respiratory (inhalation)

Active Ingredient/Active Moiety

Ingredient Name Strength
Levalbuterol hydrochloride ( UNII: WDQ1526QJM)( Levalbuterol - UNII: EDN2NBH5SS ) 1.25 mgin 3 mL

Inactive Ingredients

Ingredient Name Code
Sodium chloride ( UNII: 451W47IQ8X)
Sulfuric acid ( UNII: O40UQP6WCF)
Water ( UNII: 059QF0KO0R)
Nitrogen ( UNII: N762921K75)

Product Characteristics

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
NDA NDA020837 USA

Labeler - Actavis Pharma, Inc.( 119723554)

Establishment

Name ID/FEI Business Operations
Actavis Pharma, Inc. 119723554 ANALYSIS( 0591-2918, 0591-2919, 0591-2920), LABEL( 0591-2918, 0591-2919, 0591-2920), MANUFACTURE( 0591-2918, 0591-2919, 0591-2920), PACK( 0591-2918, 0591-2919, 0591-2920)