Lidocaine
LIDOCAINE OINTMENT USP, 5% (Spearmint Flavored)
Approved
Approval ID
7d4cc646-5678-4dc7-9f8d-e34347d52981
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 20, 2023
Manufacturers
FDA
Preferred Pharmaceuticals Inc.
DUNS: 791119022
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Lidocaine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68788-7865
Application NumberANDA086724
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lidocaine
Product Specifications
Route of AdministrationTOPICAL
Effective DateJuly 20, 2023
FDA Product Classification
INGREDIENTS (4)
LidocaineActive
Quantity: 50 mg in 1 g
Code: 98PI200987
Classification: ACTIB
polyethylene glycol 400Inactive
Code: B697894SGQ
Classification: IACT
polyethylene glycol 3350Inactive
Code: G2M7P15E5P
Classification: IACT
propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT