Albuterol Sulfate (Page 5 of 5)

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NDC 0054-0742 -87

Albuterol Sulfate

Inhalation Aerosol

90 mcg*

With Dose Indicator

FOR ORAL INHALATION WITH

ENCLOSED ACTUATOR ONLY

200 Metered Inhalations

Contains nochlorofluorocarbons (CFCs)

Net Contents 6.7 g

Rx Only

Label
(click image for full-size original)
ALBUTEROL SULFATE
albuterol sulfate aerosol, metered
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0054-0742
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
ALCOHOL
NORFLURANE
OLEIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0054-0742-87 1 CANISTER in 1 CARTON contains a CANISTER
1 200 AEROSOL, METERED in 1 CANISTER This package is contained within the CARTON (0054-0742-87)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207085 11/30/2021
Labeler — Hikma Pharmaceuticals USA Inc. (080189610)

Revised: 07/2021 Hikma Pharmaceuticals USA Inc.

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