Albuterol Sulfate Inhalation Solution (Page 5 of 5)

0.63 mg 25 Count Brick Carton

0.63 mg brick carton
(click image for full-size original)

0.63 mg 25 Count Cards Carton

0.63 mg cards carton
(click image for full-size original)

0.63 mg 30 Count Singles Carton

0.63 mg singles carton
(click image for full-size original)

1.25 mg 25 count Brick Carton

1.25 mg brick carton
(click image for full-size original)

1.25 mg 25 Count Cards Carton

1.25 mg cards carton
(click image for full-size original)

1.25 mg 30 Count Singles Carton

1.25 mg singles carton
(click image for full-size original)

ALBUTEROL SULFATE INHALATION SOLUTION albuterol sulfate solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:76204-011
Route of Administration RESPIRATORY (INHALATION) DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALBUTEROL SULFATE (ALBUTEROL) ALBUTEROL 1.25 mg in 3 mL
Inactive Ingredients
Ingredient Name Strength
EDETATE DISODIUM
SODIUM CHLORIDE
SULFURIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:76204-011-01 30 POUCH in 1 CARTON contains a POUCH (76204-011-11)
1 NDC:76204-011-11 1 VIAL in 1 POUCH This package is contained within the CARTON (76204-011-01) and contains a VIAL
1 3 mL in 1 VIAL This package is contained within a POUCH (76204-011-11) and a CARTON (76204-011-01)
2 NDC:76204-011-55 25 POUCH in 1 CARTON contains a POUCH (76204-011-05)
2 NDC:76204-011-05 5 VIAL in 1 POUCH This package is contained within the CARTON (76204-011-55) and contains a VIAL
2 3 mL in 1 VIAL This package is contained within a POUCH (76204-011-05) and a CARTON (76204-011-55)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA214531 01/04/2022
ALBUTEROL SULFATE INHALATION SOLUTION albuterol sulfate solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:76204-010
Route of Administration RESPIRATORY (INHALATION) DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALBUTEROL SULFATE (ALBUTEROL) ALBUTEROL 0.63 mg in 3 mL
Inactive Ingredients
Ingredient Name Strength
EDETATE DISODIUM
SODIUM CHLORIDE
SULFURIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:76204-010-01 30 POUCH in 1 CARTON contains a POUCH (76204-010-11)
1 NDC:76204-010-11 1 VIAL in 1 POUCH This package is contained within the CARTON (76204-010-01) and contains a VIAL
1 3 mL in 1 VIAL This package is contained within a POUCH (76204-010-11) and a CARTON (76204-010-01)
2 NDC:76204-010-55 25 POUCH in 1 CARTON contains a POUCH (76204-010-05)
2 NDC:76204-010-05 5 VIAL in 1 POUCH This package is contained within the CARTON (76204-010-55) and contains a VIAL
2 3 mL in 1 VIAL This package is contained within a POUCH (76204-010-05) and a CARTON (76204-010-55)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA214531 01/04/2022
Labeler — Ritedose Pharmaceuticals, LLC (968062294)
Establishment
Name Address ID/FEI Operations
The Ritedose Corporation 837769546 analysis (76204-010), manufacture (76204-010), pack (76204-010), label (76204-010), analysis (76204-011), manufacture (76204-011), pack (76204-011), label (76204-011)

Revised: 06/2022 Ritedose Pharmaceuticals, LLC

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