Lidocaine and Prilocaine
Lidocaine 2.5% and Prilocaine 2.5% Cream, USP
Approved
Approval ID
973d188e-8e96-4e7d-b94f-0349ca19cfe8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 24, 2023
Manufacturers
FDA
Rhodes Pharmaceuticals L.P.
DUNS: 831928986
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
NDC Product Code42858-029
Application NumberANDA213253
Marketing CategoryC73584
Route of AdministrationTOPICAL
Effective DateMarch 24, 2023
Generic NameLidocaine and Prilocaine
INGREDIENTS (6)
LidocaineActive
Quantity: 25 mg in 1 g
Code: 98PI200987
Classification: ACTIB
PrilocaineActive
Quantity: 25 mg in 1 g
Code: 046O35D44R
Classification: ACTIB
PEG-54 HYDROGENATED CASTOR OILInactive
Code: 0WZF1506N9
Classification: IACT
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)Inactive
Code: HHT01ZNK31
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT