Albuterol
Albuterol Tablets, USP Rx only
Approved
Approval ID
601a18ed-d66e-498f-a804-f1a3330827d4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 27, 2023
Manufacturers
FDA
Bryant Ranch Prepack
DUNS: 171714327
Products 1
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 Code63629-2611
Application NumberANDA207046
Product Classification
M
Marketing Category
C73584
G
Generic Name
albuterol
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 3, 2022
FDA Product Classification
INGREDIENTS (5)
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
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 LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT