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

25ct-cards-carton

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

30ct-singles-carton

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

viatris-1.25mg-25ct-cards-carton

ALBUTEROL SULFATE INHALATION SOLUTION 
albuterol sulfate solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 65302-061
Route of AdministrationRESPIRATORY (INHALATION)
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALBUTEROL SULFATE (UNII: 021SEF3731) (ALBUTEROL - UNII:QF8SVZ843E) ALBUTEROL1.25 mg  in 3 mL
Inactive Ingredients
Ingredient NameStrength
EDETATE DISODIUM (UNII: 7FLD91C86K)  
SULFURIC ACID (UNII: O40UQP6WCF)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 65302-061-0525 in 1 CARTON01/04/2022
15 in 1 POUCH
13 mL in 1 AMPULE; Type 0: Not a Combination Product
2NDC: 65302-061-0130 in 1 CARTON01/04/2022
21 in 1 POUCH
23 mL in 1 AMPULE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21453101/04/2022
ALBUTEROL SULFATE INHALATION SOLUTION 
albuterol sulfate solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 65302-065
Route of AdministrationRESPIRATORY (INHALATION)
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALBUTEROL SULFATE (UNII: 021SEF3731) (ALBUTEROL - UNII:QF8SVZ843E) ALBUTEROL1.25 mg  in 3 mL
Inactive Ingredients
Ingredient NameStrength
EDETATE DISODIUM (UNII: 7FLD91C86K)  
SULFURIC ACID (UNII: O40UQP6WCF)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 65302-065-0525 in 1 CARTON10/07/2022
15 in 1 POUCH
13 mL in 1 AMPULE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21453110/07/2022
Labeler - The Ritedose Corporation (837769546)
Establishment
NameAddressID/FEIBusiness Operations
The Ritedose Corporation837769546analysis(65302-061, 65302-065) , label(65302-061, 65302-065) , manufacture(65302-061, 65302-065) , pack(65302-061, 65302-065)

Revised: 12/2022