Lidocaine
LIDOCAINE PATCH 5%
Approved
Approval ID
2ce8a4fe-8aa6-4dc5-ad0f-3984ae68c4bc
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 22, 2019
Manufacturers
FDA
Par Pharmaceutical
DUNS: 011103059
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 Code0603-1880
Application NumberNDA020612
Product Classification
M
Marketing Category
C73605
G
Generic Name
lidocaine
Product Specifications
Route of AdministrationCUTANEOUS
Effective DateSeptember 17, 2018
FDA Product Classification
INGREDIENTS (16)
KAOLINInactive
Code: 24H4NWX5CO
Classification: IACT
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
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
CARBOXYMETHYLCELLULOSE SODIUMInactive
Code: K679OBS311
Classification: IACT
TARTARIC ACIDInactive
Code: W4888I119H
Classification: IACT
POLYACRYLIC ACID (250000 MW)Inactive
Code: 9G2MAD7J6W
Classification: IACT
SODIUM POLYACRYLATE (2500000 MW)Inactive
Code: 05I15JNI2J
Classification: IACT
DIHYDROXYALUMINUM AMINOACETATEInactive
Code: DO250MG0W6
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT