Albuterol
Albuterol Tablets, USP (2 mg and 4 mg) Rx only
Approved
Approval ID
230d66fc-f62c-42a6-adb3-0a0f879c8ad4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 20, 2023
Manufacturers
FDA
Amneal Pharmaceuticals NY LLC
DUNS: 123797875
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Albuterol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69238-1345
Application NumberANDA208804
Product Classification
M
Marketing Category
C73584
G
Generic Name
Albuterol
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 20, 2023
FDA Product Classification
INGREDIENTS (5)
ALBUTEROL SULFATEActive
Quantity: 4 mg in 1 1
Code: 021SEF3731
Classification: ACTIM
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Albuterol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69238-1344
Application NumberANDA208804
Product Classification
M
Marketing Category
C73584
G
Generic Name
Albuterol
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 20, 2023
FDA Product Classification
INGREDIENTS (5)
ALBUTEROL SULFATEActive
Quantity: 2 mg in 1 1
Code: 021SEF3731
Classification: ACTIM
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT