MedPath

Lidocaine

LIDOCAINE OINTMENT USP, 5%

Approved
Approval ID

a2e56162-2d2f-434c-8581-c7b3f68192b6

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 30, 2019

Manufacturers
FDA

IPG Pharmaceuticals, Inc.

DUNS: 080441238

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

LIDOCAINE

PRODUCT DETAILS

NDC Product Code71085-001
Application NumberANDA086724
Marketing CategoryC73584
Route of AdministrationTOPICAL
Effective DateJanuary 30, 2019
Generic NameLIDOCAINE

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

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Lidocaine - FDA Drug Approval Details