Albuterol Sulfate Inhalation Solution, 0.5%
Albuterol Sulfate Inhalation Solution, EQ 0.5% Base (2.5 mg/0.5 mL)
Approved
Approval ID
fdb4ac5a-bf0d-4896-89f7-1828c081b79e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 24, 2025
Manufacturers
FDA
Ritedose Pharmaceuticals, LLC
DUNS: 968062294
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Albuterol Sulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code76204-027
Application NumberANDA218386
Product Classification
M
Marketing Category
C73584
G
Generic Name
Albuterol Sulfate
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateMarch 24, 2025
FDA Product Classification
INGREDIENTS (3)
SULFURIC ACIDInactive
Code: O40UQP6WCF
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ALBUTEROL SULFATEActive
Quantity: 2.5 mg in 0.5 mL
Code: 021SEF3731
Classification: ACTIM