ALBUTEROL SULFATE INHALATION SOLUTION- albuterol sulfate solution 
The Ritedose Corporation

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Albuterol Sulfate Inhalation Solution, 0.63 mg/3 mL

NDC 76204-010-55

Albuterol Sulfate Inhalation Solution

0.63 mg* / 3 mL

*Each unit does vial contains 0.63 mg of albuterol equivalent to 0.75 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, 0.63 mg/3 mL, 25 Count Cards Carton

25ct-cards-carton

RDP Albuterol Sulfate Inhalation Solution, 0.63 mg/3 mL, 30 Count Singles Carton

30ct-singles-carton

Mylan Albuterol Sulfate Inhalation Solution, 0.63 mg/3 mL, 25 Count Cards carton

viatris-25ct-cards-carton

ALBUTEROL SULFATE INHALATION SOLUTION 
albuterol sulfate solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65302-060
Route of AdministrationRESPIRATORY (INHALATION)
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALBUTEROL SULFATE (UNII: 021SEF3731) (ALBUTEROL - UNII:QF8SVZ843E) ALBUTEROL0.63 mg  in 3 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
SULFURIC ACID (UNII: O40UQP6WCF)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65302-060-0130 in 1 CARTON01/04/2022
11 in 1 POUCH
13 mL in 1 AMPULE; Type 0: Not a Combination Product
2NDC:65302-060-0525 in 1 CARTON01/04/2022
25 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:65302-064
Route of AdministrationRESPIRATORY (INHALATION)
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALBUTEROL SULFATE (UNII: 021SEF3731) (ALBUTEROL - UNII:QF8SVZ843E) ALBUTEROL0.63 mg  in 3 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
SULFURIC ACID (UNII: O40UQP6WCF)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65302-064-0525 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(65302-060, 65302-064) , label(65302-060, 65302-064) , manufacture(65302-060, 65302-064) , pack(65302-060, 65302-064)

Revised: 12/2022
Document Id: f06cec73-d56c-eb04-e053-2a95a90a4d50
Set id: f06cec73-d56b-eb04-e053-2a95a90a4d50
Version: 1
Effective Time: 20221222
 
The Ritedose Corporation