LIDOCAINE HYDROCHLORIDE
LIDOCAINE HYDROCHLORIDE TOPICAL SOLUTION, USP 4%
Approved
Approval ID
6f79a974-6d8f-480a-93be-1b4bea1cf603
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 28, 2023
Manufacturers
FDA
Wockhardt USA LLC.
DUNS: 170508365
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 Code64679-465
Application NumberANDA087881
Product Classification
M
Marketing Category
C73584
G
Generic Name
lidocaine hydrochloride
Product Specifications
Route of AdministrationTOPICAL
Effective DateMarch 28, 2023
FDA Product Classification
INGREDIENTS (5)
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
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