Lidocaine
Lidocaine Ointment USP, 5%
Approved
Approval ID
2718a56f-345f-4d88-82d2-364e0f155d97
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 13, 2023
Manufacturers
FDA
Unit Dose Services
DUNS: 831995316
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
lidocaine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50436-0474
Application NumberANDA210958
Product Classification
M
Marketing Category
C73584
G
Generic Name
lidocaine
Product Specifications
Route of AdministrationTOPICAL
Effective DateJuly 13, 2023
FDA Product Classification
INGREDIENTS (3)
LIDOCAINEActive
Quantity: 50 mg in 1 g
Code: 98PI200987
Classification: ACTIB
POLYETHYLENE GLYCOL 1450Inactive
Code: OJ4Z5Z32L4
Classification: IACT
POLYETHYLENE GLYCOL 300Inactive
Code: 5655G9Y8AQ
Classification: IACT