VENTOLIN HFA (Page 5 of 5)

Ventolin HFA Inhaler

Label Image
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VENTOLIN HFA
albuterol sulfate aerosol, metered
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53002-1584(NDC:0173-0682)
Route of Administration RESPIRATORY (INHALATION) DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALBUTEROL SULFATE (ALBUTEROL) ALBUTEROL 90 ug
Inactive Ingredients
Ingredient Name Strength
NORFLURANE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53002-1584-1 1 INHALER in 1 CARTON contains a INHALER
1 60 AEROSOL, METERED in 1 INHALER This package is contained within the CARTON (53002-1584-1)
2 NDC:53002-1584-2 1 INHALER in 1 CARTON contains a INHALER
2 200 AEROSOL, METERED in 1 INHALER This package is contained within the CARTON (53002-1584-2)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020983 06/09/2006
Labeler — RPK Pharmaceuticals, Inc. (147096275)
Establishment
Name Address ID/FEI Operations
RPK Pharmaceuticals, Inc. 147096275 RELABEL (53002-1584)

Revised: 12/2020 RPK Pharmaceuticals, Inc.

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