ALBUTEROL SULFATE (Page 5 of 5)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

R_x Only

NDC 69097-142-60

Albuterol Sulfate Inhalation Aerosol

90 mcg*

With Dose Indicator

FOR ORAL INHALATION WITH

ENCLOSED ACTUATOR ONLY

200

METERED

INHALATIONS

NET CONTENTS 6.7g

Cipla

R_x Only

NDC 69097-142-60

Albuterol Sulfate

Inhalation Aerosol

90 mcg*

With Dose Indicator

FOR ORAL INHALATION WITH

ENCLOSED ACTUATOR ONLY

200

METERED

INHALATIONS

NET CONTENTS 6.7g

CONTAINS NO

CHLOROFLUOROCARBONS (CFCs).

Cipla

R_x Only

NDC 69097-142-60

Albuterol Sulfate Inhalation Aerosol

90 mcg*

With Dose Indicator

FOR ORAL INHALATION WITH

ENCLOSED ACTUATOR ONLY

200

METERED

INHALATIONS

NET CONTENTS 6.7g

Cipla

R_x Only

NDC 69097-142-60

Albuterol Sulfate

Inhalation Aerosol

90 mcg*

With Dose Indicator

FOR ORAL INHALATION WITH

ENCLOSED ACTUATOR ONLY

200

METERED

INHALATIONS

NET CONTENTS 6.7g

CONTAINS NO

CHLOROFLUOROCARBONS (CFCs).

Cipla

ALBUTEROL SULFATE albuterol sulfate inhalant

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69097-142 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 OLEIC ACID NORFLURANE ALCOHOL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:69097-142-60 1 CANISTER in 1 CARTON contains a CANISTER 1 200 INHALANT in 1 CANISTER This package is contained within the CARTON (69097-142-60)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA209959 04/08/2020

Labeler — Cipla USA Inc. (078719707)

Registrant — Cipla USA Inc. (078719707)

Establishment
Name	Address	ID/FEI	Operations
Cipla Ltd. Indore		918596409	ANALYSIS (69097-142), MANUFACTURE (69097-142), LABEL (69097-142), PACK (69097-142)

Establishment
Name	Address	ID/FEI	Operations
Cipla Ltd. Patalganga unit II		916940208	ANALYSIS (69097-142), API MANUFACTURE (69097-142)

Establishment
Name	Address	ID/FEI	Operations
Invagen Pharmaceuticals Inc., Fall River		117741117	ANALYSIS (69097-142), LABEL (69097-142), MANUFACTURE (69097-142), PACK (69097-142)

Revised: 01/2022 Cipla USA Inc.