LIDOCAINE
Lidocaine Patch 5%Rx only
Approved
Approval ID
1b0786e1-cd62-4a76-8866-f2206faea69a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 28, 2021
Manufacturers
FDA
EXELAN PHARMACEUTICALS, INC.
DUNS: 967795266
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 Code76282-669
Application NumberANDA205882
Product Classification
M
Marketing Category
C73584
G
Generic Name
LIDOCAINE
Product Specifications
Route of AdministrationCUTANEOUS
Effective DateOctober 28, 2021
FDA Product Classification
INGREDIENTS (16)
LIDOCAINEActive
Quantity: 700 mg in 1 1
Code: 98PI200987
Classification: ACTIB
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
DIETHYLENE GLYCOL MONOETHYL ETHERInactive
Code: A1A1I8X02B
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PHOSPHORIC ACIDInactive
Code: E4GA8884NN
Classification: IACT
DIHYDROXYALUMINUM AMINOACETATEInactive
Code: DO250MG0W6
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
TARTARIC ACIDInactive
Code: W4888I119H
Classification: IACT
UREAInactive
Code: 8W8T17847W
Classification: IACT
CARBOXYMETHYLCELLULOSE SODIUM (0.9 CARBOXYMETHYL SUBSTITUTION PER SACCHARIDE; 120 MPA.S AT 1%)Inactive
Code: 379M03VC9O
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT