Albuterol Sulfate Solution

NDC 60687- 395-83

Albuterol Sulfate Inhalation Solution, 0.083%*

2.5 mg/3 mL*

*Potency expressed as albuterol, equivalent to 3 mg albuterol sulfate.

30 x 3 mL Sterile Unit-Dose Vials,

each in a foil pouch

Rx Only

FOR ORAL INHALATION ONLY

Principal Display Panel - AHP Albuterol Sulfate 30 ct Carton

NDC 60687- 395-83

Albuterol Sulfate Inhalation Solution, 0.083%*

2.5 mg/3 mL*

*Potency expressed as albuterol, equivalent to 3 mg albuterol sulfate.

30 x 3 mL Sterile Unit-Dose Vials,

each in a foil pouch

Rx Only

FOR ORAL INHALATION ONLY

AHP Albuterol Sulfate 30 ct Carton

ALBUTEROL SULFATE
albuterol sulfate solution

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALBUTEROL SULFATE (UNII: 021SEF3731) (ALBUTEROL - UNII:QF8SVZ843E)	ALBUTEROL	2.5 mg in 3 mL

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:65302-045-01	30 in 1 CARTON	12/26/2018
1		1 in 1 POUCH
1		3 mL in 1 AMPULE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA077839	12/26/2018

Labeler - The Ritedose Corporation (837769546)

Name	Address	ID/FEI	Business Operations
Establishment
The Ritedose Corporation		837769546	analysis(65302-045) , manufacture(65302-045) , pack(65302-045) , label(65302-045)

Revised: 12/2019

Document Id: 9adaf3f5-104b-264f-e053-2a95a90ad788

Set id: 9adaf3f5-104a-264f-e053-2a95a90ad788

Version: 1

Effective Time: 20191229

The Ritedose Corporation