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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code46708-582
Application NumberANDA213923
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lidocaine and Prilocaine
Product Specifications
Route of AdministrationTOPICAL
Effective DateApril 8, 2025
FDA Product Classification
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