Lidocaine and Prilocaine
Lidocaine 2.5% and Prilocaine 2.5% Cream
Approved
Approval ID
5900691d-8b50-7752-e053-2991aa0a5c5c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 28, 2022
Manufacturers
FDA
NuCare Pharamceuticals,Inc.
DUNS: 010632300
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 Code68071-1625
Application NumberANDA076290
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lidocaine and Prilocaine
Product Specifications
Route of AdministrationTOPICAL
Effective DateJanuary 28, 2022
FDA Product Classification
INGREDIENTS (6)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
POLYOXYL 40 HYDROGENATED CASTOR OILInactive
Code: 7YC686GQ8F
Classification: IACT
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)Inactive
Code: Z135WT9208
Classification: IACT
LIDOCAINEActive
Quantity: 25 mg in 1 g
Code: 98PI200987
Classification: ACTIB
PRILOCAINEActive
Quantity: 25 mg in 1 g
Code: 046O35D44R
Classification: ACTIB