ALBUTEROL SULFATE (Page 5 of 5)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Rx Only

NDC 72572-014-01

Albuterol Sulfate Inhalation Aerosol

90 mcg*

With Dose Indicator

FOR ORAL INHALATION WITH

ENCLOSED ACTUATOR ONLY

200

METERED

INHALATIONS

NET CONTENTS 6.7g

90mcg
(click image for full-size original)

Rx Only

NDC 72572-014-01

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).

carton
(click image for full-size original)
ALBUTEROL SULFATE albuterol sulfate inhalant
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72572-014
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:72572-014-01 1 CANISTER in 1 CARTON contains a CANISTER
1 200 INHALANT in 1 CANISTER This package is contained within the CARTON (72572-014-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209959 06/07/2021
Labeler — Civica Inc. (081373942)
Registrant — Cipla USA Inc. (078719707)
Establishment
Name Address ID/FEI Operations
Cipla Ltd. Indore 918596409 ANALYSIS (72572-014), MANUFACTURE (72572-014), PACK (72572-014)

Revised: 02/2022 Civica Inc.

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