Lidocaine
LIDOCAINE OINTMENT USP, 5%
Approved
Approval ID
88ca9cba-0c4a-482f-b502-ceefdb1bfbcd
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 7, 2022
Manufacturers
FDA
Fougera Pharmaceuticals Inc.
DUNS: 043838424
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 Code0168-0204
Application NumberANDA080198
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lidocaine
Product Specifications
Route of AdministrationTOPICAL
Effective DateOctober 15, 2011
FDA Product Classification
INGREDIENTS (3)
polyethylene glycol 300Inactive
Code: 5655G9Y8AQ
Classification: IACT
lidocaineActive
Quantity: 50 mg in 1 g
Code: 98PI200987
Classification: ACTIB
polyethylene glycol 1450Inactive
Code: OJ4Z5Z32L4
Classification: IACT