Budesonide Inhalation (Page 8 of 8)

Package/Label Display Panel – Carton – 0.5 mg per 2 mL

NDC 60687- 524 -83

Budesonide
Inhalation Suspension

0.5 mg/2 mL

Rx Only
FOR INHALATION ONLY

Once an Ampule is opened, use the contents immediately
For use only in a jet nebulizer.
Do NOT use in an ultrasonic nebulizer.

30 x 2 mL unit-dose ampules
each in a foil pouch.

Each unit-dose ampule delivers 2 mL of a sterile suspension
containing 0.5 mg of micronized budesonide USP.

Usual Dosage: Once a foil pouch is opened, use the ampule within 2
weeks. Use as directed by physician. Follow the Patient Instructions
for proper use of Budesonide Inhalation Suspension. See package
insert for full prescribing information.

Store at 20° to 25°C (68° to 77°F); excursions permitted
between 15° to 30°C (59° to 86°F) [see USP Controlled Room
Temperature].
Do not freeze. Protect from light.

Store unopened ampule in foil pouch placed upright in the
carton.

Inactives: anhydrous citric acid, disodium edetate dihydrate,
polysorbate 80, sodium chloride, sodium citrate anhydrous and
water for injection.

Keep this and all drugs out of reach of children.

FOR YOUR PROTECTION:
Do not use if ampule appears damaged.

The unit-dose package is not child resistant.
If dispensed for outpatient use, a child-resistant
container should be utilized.

The drug product contained in this package is from
NDC# 68180-984, Lupin Pharmaceuticals, Inc.

Distributed by:
American Health Packaging Columbus, OH 43217

5552483/1021

Package/Label Display Panel – Foil Pouch – 0.5 mg per 2 mL

NDC 60687- 524 -79

Budesonide
Inhalation
Suspension

0.5 mg/2 mL

FOR INHALATION ONLY

Each unit-dose ampule delivers 2 mL of a sterile
suspension containing 0.5 mg of micronized
budesonide USP.

Shake gently using a circular motion prior to
use. Once ampule is opened, use immediately.
For use only in a jet nebulizer. Do NOT use in an
ultrasonic nebulizer.

Usual Dosage: Use as directed by physician.
Follow the Patient Instructions for proper use of
Budesonide Inhalation Suspension. See
package insert for full prescribing information.

Store at 20° to 25°C (68° to 77°F);
excursions permitted between 15° to
30°C (59° to 86°F) [see USP Controlled
Room Temperature]. Do not freeze.
Protect from light.

Store unopened ampule in foil pouch
placed upright in the carton. Once a foil
pouch is opened, use the ampule within
two weeks.

Inactives: anhydrous citric acid,
disodium edetate dihydrate, polysorbate
80, sodium chloride, sodium citrate
anhydrous and water for injection.

Keep this and all drugs
out of reach of children.

Rx Only

The drug product contained in this package is from
NDC# 68180-984, Lupin Pharmaceuticals, Inc.

Distributed by:
American Health Packaging Columbus, OH 43217

0452483/0621

BUDESONIDE INHALATION budesonide inhalation suspension

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60687-524(NDC:68180-984) Route of Administration RESPIRATORY (INHALATION) DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BUDESONIDE (BUDESONIDE) BUDESONIDE 0.5 mg in 2 mL

Inactive Ingredients Ingredient Name Strength WATER ANHYDROUS CITRIC ACID EDETATE DISODIUM POLYSORBATE 80 SODIUM CHLORIDE SODIUM CITRATE, UNSPECIFIED FORM

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:60687-524-83 30 POUCH in 1 CARTON contains a POUCH (60687-524-79) 1 NDC:60687-524-79 1 AMPULE in 1 POUCH This package is contained within the CARTON (60687-524-83) and contains a AMPULE 1 2 mL in 1 AMPULE This package is contained within a POUCH (60687-524-79) and a CARTON (60687-524-83)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA210897 12/15/2019

Labeler — American Health Packaging (929561009)

Revised: 01/2022 American Health Packaging