Lidocaine Hydrochloride
Lidocaine Hydrochloride Topical Solution USP, 4% Rx only
Approved
Approval ID
9920daef-b156-4a14-b641-f714191ffb5c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 24, 2023
Manufacturers
FDA
PAI Holdings, LLC
DUNS: 044940096
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Lidocaine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0121-0972
Application NumberANDA204494
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lidocaine Hydrochloride
Product Specifications
Route of AdministrationTOPICAL
Effective DateOctober 24, 2023
FDA Product Classification
INGREDIENTS (4)
Lidocaine HydrochlorideActive
Quantity: 40 mg in 1 mL
Code: V13007Z41A
Classification: ACTIR
WaterInactive
Code: 059QF0KO0R
Classification: IACT
MethylparabenInactive
Quantity: 1 mg in 1 mL
Code: A2I8C7HI9T
Classification: IACT
Sodium HydroxideInactive
Code: 55X04QC32I
Classification: IACT