Lidocaine and Prilocaine
LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
Approved
Approval ID
69fed044-a6b8-40a7-9ba1-7fb10435ca74
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 29, 2023
Manufacturers
FDA
Preferred Pharmaceuticals Inc.
DUNS: 791119022
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
lidocaine and prilocaine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68788-8150
Application NumberANDA076453
Product Classification
M
Marketing Category
C73584
G
Generic Name
lidocaine and prilocaine
Product Specifications
Route of AdministrationTOPICAL
Effective DateNovember 29, 2023
FDA Product Classification
INGREDIENTS (6)
prilocaineActive
Quantity: 25 mg in 1 g
Code: 046O35D44R
Classification: ACTIB
lidocaineActive
Quantity: 25 mg in 1 g
Code: 98PI200987
Classification: ACTIB
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)Inactive
Code: Z135WT9208
Classification: IACT
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT
PEG-50 HYDROGENATED CASTOR OILInactive
Code: R07D3A9614
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT