Lidocaine
LIDOCAINE OINTMENT USP, 5%
Approved
Approval ID
c18f0c2b-cd05-4458-888f-47b4a1106937
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 3, 2020
Manufacturers
FDA
Asclemed USA, Inc.
DUNS: 059888437
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 Code76420-131
Application NumberANDA205318
Product Classification
M
Marketing Category
C73584
G
Generic Name
lidocaine
Product Specifications
Route of AdministrationTOPICAL
Effective DateNovember 3, 2020
FDA Product Classification
INGREDIENTS (3)
POLYETHYLENE GLYCOL 300Inactive
Code: 5655G9Y8AQ
Classification: IACT
POLYETHYLENE GLYCOL 1450Inactive
Code: OJ4Z5Z32L4
Classification: IACT
LIDOCAINEActive
Quantity: 50 mg in 1 g
Code: 98PI200987
Classification: ACTIB