Lidocaine and Prilocaine
Lidocaine and Prilocaine USP, 2.5%/2.5%
Approved
Approval ID
7a790e8b-ff12-411f-bacc-9141d4dfef58
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 6, 2018
Manufacturers
FDA
Teligent Pharma, Inc.
DUNS: 011036910
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 Code52565-007
Application NumberANDA205887
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lidocaine and Prilocaine
Product Specifications
Route of AdministrationTOPICAL
Effective DateJuly 10, 2018
FDA Product Classification
INGREDIENTS (6)
LidocaineActive
Quantity: 25 mg in 1 g
Code: 98PI200987
Classification: ACTIB
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Peg-60 Hydrogenated Castor OilInactive
Code: 02NG325BQG
Classification: IACT
PrilocaineActive
Quantity: 25 mg in 1 g
Code: 046O35D44R
Classification: ACTIB
Sodium HydroxideInactive
Code: 55X04QC32I
Classification: IACT
Carbomer Homopolymer Type B (allyl Pentaerythritol Crosslinked)Inactive
Code: HHT01ZNK31
Classification: IACT