MedPath

Lidocaine

Lidocaine Ointment USP, 5% FOR TOPICAL USE DO NOT USE IN THE EYES Rx Only

Approved
Approval ID

960f6d0a-82af-45e9-89d5-cea808004ebb

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 20, 2023

Manufacturers
FDA

Amneal Pharmaceuticals LLC

DUNS: 123797875

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 Code65162-918
Application NumberANDA206297
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lidocaine
Product Specifications
Route of AdministrationTOPICAL
Effective DateDecember 20, 2023
FDA Product Classification

INGREDIENTS (2)

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
LIDOCAINEActive
Quantity: 50 mg in 1 g
Code: 98PI200987
Classification: ACTIB

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

Lidocaine - FDA Drug Approval Details