Albuterol Sulfate
Albuterol Sulfate Inhalation Solution, 0.083% 2.5 mg*/3 ml
Approved
Approval ID
8153d82c-b5c5-4aa2-bce5-b69cf2d23f5d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 16, 2020
Manufacturers
FDA
Asclemed USA, Inc.
DUNS: 059888437
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 Code76420-087
Application NumberANDA074880
Product Classification
M
Marketing Category
C73584
G
Generic Name
Albuterol Sulfate
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateOctober 16, 2020
FDA Product Classification
INGREDIENTS (4)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SULFURIC ACIDInactive
Code: O40UQP6WCF
Classification: IACT
ALBUTEROL SULFATEActive
Quantity: 2.5 mg in 3 mL
Code: 021SEF3731
Classification: ACTIM