Albuterol Sulfate: Package Insert and Label Information (Page 4 of 4)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL — Inhaler Canister Label

NDC 71205-732-85

Albuterol Sulfate Inhalation Aerosol

90 mcg per actuation

For Oral Inhalation with Enclosed Actuator Only

Rx only

200 Metered Inhalations

8.5 g Net Contents

71205-732-85
(click image for full-size original)
ALBUTEROL SULFATE albuterol sulfate aerosol, metered
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71205-732(NDC:68180-963)
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
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71205-732-85 1 CANISTER in 1 CARTON contains a CANISTER
1 200 AEROSOL, METERED in 1 CANISTER This package is contained within the CARTON (71205-732-85)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209954 08/25/2020
Labeler — Proficient Rx LP (079196022)
Establishment
Name Address ID/FEI Operations
Proficient Rx LP 079196022 RELABEL (71205-732)

Revised: 01/2023 Proficient Rx LP

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