Lidocaine
Lidocaine 5% Ointment
Approved
Approval ID
f18be373-09d2-6fc3-e053-2a95a90a2a06
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 10, 2023
Manufacturers
FDA
Advanced Rx Pharmacy of Tennessee, LLC
DUNS: 117023142
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 Code80425-0249
Application NumberANDA205318
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lidocaine
Product Specifications
Route of AdministrationTOPICAL
Effective DateJanuary 10, 2023
FDA Product Classification
INGREDIENTS (1)
LIDOCAINEActive
Quantity: 50 mg in 1 g
Code: 98PI200987
Classification: ACTIB
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
LOINC: 51945-4Updated: 1/10/2023
Principal Display Panel
SPL UNCLASSIFIED SECTION
LOINC: 42229-5Updated: 1/10/2023
SPL Unclassified Section
FOR TOPICAL USE ONLY
DO NOT USE IN THE EYES
Rx Only