Lidocaine and Prilocaine
Lidocaine and Prilocaine Cream, USP 2.5%/2.5%
Approved
Approval ID
54198bf6-c93c-42cd-9b2b-63918eb32880
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 8, 2025
Manufacturers
FDA
Alembic Pharmaceuticals Limited
DUNS: 650574663
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 Code46708-582
Application NumberANDA213923
Marketing CategoryC73584
Route of AdministrationTOPICAL
Effective DateApril 8, 2025
Generic NameLidocaine and Prilocaine
INGREDIENTS (6)
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
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