Lidocaine
Lidocaine Patch
Approved
Approval ID
20b8df6b-34d3-468c-9726-39fe947da274
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 23, 2018
Manufacturers
FDA
Unit Dose Services
DUNS: 831995316
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 Code50436-1330
Application NumberANDA200675
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lidocaine
Product Specifications
Route of AdministrationTOPICAL
Effective DateDecember 12, 2017
FDA Product Classification
INGREDIENTS (15)
UREAInactive
Code: 8W8T17847W
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
LIDOCAINEActive
Quantity: 50 mg in 1 g
Code: 98PI200987
Classification: ACTIB
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
KAOLINInactive
Code: 24H4NWX5CO
Classification: IACT
DIHYDROXYALUMINUM AMINOACETATEInactive
Code: DO250MG0W6
Classification: IACT
TARTARIC ACIDInactive
Code: W4888I119H
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMInactive
Code: K679OBS311
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT