Albuterol Sulfate Inhalation Solution, 1.25 mg/3 mL

Albuterol Sulfate Inhalation Solution by

Drug Labeling and Warnings

Albuterol Sulfate Inhalation Solution by is a Prescription medication manufactured, distributed, or labeled by The Ritedose Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ALBUTEROL SULFATE INHALATION SOLUTION- albuterol sulfate solution 
The Ritedose Corporation

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Albuterol Sulfate Inhalation Solution, 1.25 mg/3 mL

NDC: 76204-011-55

Albuterol Sulfate Inhalation Solution

1.25 mg* / 3 mL

*Each unit dose vial contains 1.25 mg of albuterol equivalent to 1.5 mg albuterol sulfate.

For Inhalation Only

Sterile Unit-Dose Vials

Carton contains: 5 pouches of 5 x 3 mL vials each.

RDP Albuterol Sulfate Inhalation Solution, 1.25 mg/3 mL, 25 Count Cards Carton

RDP Albuterol Sulfate Inhalation Solution, 1.25 mg/3 mL, 30 Count Singles Carton

Mylan Albuterol Sulfate Inhalation Solution, 1.25 mg/3 mL, 25 Count Cards Carton

ALBUTEROL SULFATE INHALATION SOLUTION 
albuterol sulfate solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 65302-061
Route of Administration	RESPIRATORY (INHALATION)

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALBUTEROL SULFATE (UNII: 021SEF3731) (ALBUTEROL - UNII:QF8SVZ843E)	ALBUTEROL	1.25 mg  in 3 mL

Inactive Ingredients
Ingredient Name	Strength
EDETATE DISODIUM (UNII: 7FLD91C86K)
SULFURIC ACID (UNII: O40UQP6WCF)
SODIUM CHLORIDE (UNII: 451W47IQ8X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65302-061-05	25 in 1 CARTON	01/04/2022
1		5 in 1 POUCH
1		3 mL in 1 AMPULE; Type 0: Not a Combination Product
2	NDC: 65302-061-01	30 in 1 CARTON	01/04/2022
2		1 in 1 POUCH
2		3 mL in 1 AMPULE; Type 0: Not a Combination Product

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: 65302-065
Route of Administration	RESPIRATORY (INHALATION)

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALBUTEROL SULFATE (UNII: 021SEF3731) (ALBUTEROL - UNII:QF8SVZ843E)	ALBUTEROL	1.25 mg  in 3 mL

Inactive Ingredients
Ingredient Name	Strength
EDETATE DISODIUM (UNII: 7FLD91C86K)
SULFURIC ACID (UNII: O40UQP6WCF)
SODIUM CHLORIDE (UNII: 451W47IQ8X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65302-065-05	25 in 1 CARTON	10/07/2022
1		5 in 1 POUCH
1		3 mL in 1 AMPULE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA214531	10/07/2022

Labeler - The Ritedose Corporation (837769546)

Establishment
Name	Address	ID/FEI	Business Operations
The Ritedose Corporation		837769546	analysis(65302-061, 65302-065) , label(65302-061, 65302-065) , manufacture(65302-061, 65302-065) , pack(65302-061, 65302-065)

Revised: 12/2022

Document Id: f06d3ff4-0b82-bd33-e053-2a95a90af7e9

34391-3

Set id: f06d3ff4-0b81-bd33-e053-2a95a90af7e9

Version: 1

Effective Time: 20221222