Lidocaine Hydrochloride
Lidocaine Hydrochloride Topical Solution, USP Rx only
Approved
Approval ID
ffb2d794-2c88-48a2-beff-d01b6fcea51f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 25, 2022
Manufacturers
FDA
Novitium Pharma LLC
DUNS: 080301870
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 Code70954-518
Application NumberANDA216250
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lidocaine Hydrochloride
Product Specifications
Route of AdministrationTOPICAL
Effective DateMarch 25, 2022
FDA Product Classification
INGREDIENTS (4)
LIDOCAINE HYDROCHLORIDEActive
Quantity: 40 mg in 1 mL
Code: V13007Z41A
Classification: ACTIR
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT