Ipratropium bromide and albuterol sulfate solution

Ingredients and appearance - Product information

Ipratropium bromide and albuterol sulfate solution- Ipratropium bromide and albuterol sulfate

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 63187-529
Route of Administration Respiratory (inhalation)

Active Ingredient/Active Moiety

Ingredient Name Strength
Ipratropium bromide ( UNII: J697UZ2A9J)( Ipratropium - UNII: GR88G0I6UL ) 0.5 mgin 3 mL
Albuterol sulfate ( UNII: 021SEF3731)( Albuterol - UNII: QF8SVZ843E ) 2.5 mgin 3 mL

Inactive Ingredients

Ingredient Name Code
Sodium chloride ( UNII: 451W47IQ8X)
Hydrochloric acid ( UNII: QTT17582CB)

Product Characteristics

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA202496 USA

Labeler - Proficient Rx LP( 079196022)

Establishment

Name ID/FEI Business Operations
Proficient Rx LP 079196022 REPACK( 63187-529), RELABEL( 63187-529)