Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Proficient Rx LP
Proficient Rx LP
079196022
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Levalbuterol
Product Details
NDC Product Code
63187-953Application Number
ANDA090297Marketing Category
ANDA (C73584)Route of Administration
RESPIRATORY (INHALATION)Effective Date
December 1, 2018SULFURIC ACIDInactive
Code: O40UQP6WCFClass: IACT
LevosalbutamolActive
Code: WDQ1526QJMClass: ACTIMQuantity: 0.63 mg in 3 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86KClass: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95KClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT