albuterol sulfate
ALBUTEROL TABLETS USP
Approved
Approval ID
87b8cd3c-2849-4b50-b63e-9ea379165c07
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 30, 2019
Manufacturers
FDA
Sun Pharmaceutical Industries, Inc.
DUNS: 146974886
Products 2
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 Code53489-176
Application NumberANDA072637
Product Classification
M
Marketing Category
C73584
G
Generic Name
albuterol sulfate
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 30, 2019
FDA Product Classification
INGREDIENTS (5)
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
albuterol sulfateActive
Quantity: 2 mg in 1 1
Code: 021SEF3731
Classification: ACTIM
anhydrous lactoseInactive
Code: 3SY5LH9PMK
Classification: IACT
starch, cornInactive
Code: O8232NY3SJ
Classification: IACT
sodium starch glycolate type a potatoInactive
Code: 5856J3G2A2
Classification: IACT
albuterol sulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code53489-177
Application NumberANDA072637
Product Classification
M
Marketing Category
C73584
G
Generic Name
albuterol sulfate
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 30, 2019
FDA Product Classification
INGREDIENTS (5)
anhydrous lactoseInactive
Code: 3SY5LH9PMK
Classification: IACT
albuterol sulfateActive
Quantity: 4 mg in 1 1
Code: 021SEF3731
Classification: ACTIM
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
starch, cornInactive
Code: O8232NY3SJ
Classification: IACT
sodium starch glycolate type a potatoInactive
Code: 5856J3G2A2
Classification: IACT