LIDODERM
LIDODERM® (Lidocaine Patch 5%)
Approved
Approval ID
f1c40164-4626-4290-9012-c00e33420a33
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 27, 2022
Manufacturers
FDA
Endo Pharmaceuticals Inc.
DUNS: 178074951
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 Code63481-687
Application NumberNDA020612
Product Classification
M
Marketing Category
C73594
G
Generic Name
lidocaine
Product Specifications
Route of AdministrationCUTANEOUS
Effective DateJanuary 20, 2023
FDA Product Classification
INGREDIENTS (11)
LIDOCAINEActive
Quantity: 50 mg in 1 g
Code: 98PI200987
Classification: ACTIB
UREAInactive
Code: 8W8T17847W
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
TARTARIC ACIDInactive
Code: W4888I119H
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
CARBOXYMETHYLCELLULOSE SODIUMInactive
Code: K679OBS311
Classification: IACT