ALBUTEROL SULFATE
ALBUTEROL SULFATE
Approved
Approval ID
8ee98719-c248-4373-e053-2995a90ae626
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 30, 2019
Manufacturers
FDA
Direct_Rx
DUNS: 079254320
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 Code72189-002
Application NumberANDA077839
Product Classification
M
Marketing Category
C73584
G
Generic Name
ALBUTEROL SULFATE
Product Specifications
Route of AdministrationINTRABRONCHIAL
Effective DateJuly 30, 2019
FDA Product Classification
INGREDIENTS (3)
ALBUTEROL SULFATEActive
Quantity: 2.5 mg in 3 mL
Code: 021SEF3731
Classification: ACTIM
SULFURIC ACIDInactive
Code: O40UQP6WCF
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT