Albuterol Sulfate (Page 3 of )

ALBUTEROL SULFATE- albuterol sulfate solution
The Ritedose Corporation

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
(click image for full-size original)
ALBUTEROL SULFATE
albuterol sulfate solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65302-045
Route of Administration RESPIRATORY (INHALATION) DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALBUTEROL SULFATE (ALBUTEROL) ALBUTEROL 2.5 mg in 3 mL
Inactive Ingredients
Ingredient Name Strength
SULFURIC ACID
WATER
SODIUM CHLORIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65302-045-01 30 POUCH in 1 CARTON contains a POUCH
1 1 AMPULE in 1 POUCH This package is contained within the CARTON (65302-045-01) and contains a AMPULE
1 3 mL in 1 AMPULE This package is contained within a POUCH and a CARTON (65302-045-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077839 12/26/2018
Labeler — The Ritedose Corporation (837769546)
Establishment
Name Address ID/FEI Operations
The Ritedose Corporation 837769546 analysis (65302-045), manufacture (65302-045), pack (65302-045), label (65302-045)

Revised: 12/2019 The Ritedose Corporation

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