Lidocaine Hydrochloride
Lidocaine Hydrochloride Topical Solution, USP Rx only
Approved
Approval ID
e1badbba-59af-e451-e053-2a95a90a49f8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 15, 2023
Manufacturers
FDA
Marlex Pharmaceuticals, Inc.
DUNS: 782540215
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 Code10135-736
Application NumberANDA216250
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lidocaine Hydrochloride
Product Specifications
Route of AdministrationTOPICAL
Effective DateNovember 15, 2023
FDA Product Classification
INGREDIENTS (4)
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
LIDOCAINE HYDROCHLORIDEActive
Quantity: 40 mg in 1 mL
Code: V13007Z41A
Classification: ACTIR