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

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code71085-001
Application NumberANDA086724
Product Classification
M
Marketing Category
C73584
G
Generic Name
LIDOCAINE
Product Specifications
Route of AdministrationTOPICAL
Effective DateJanuary 30, 2019
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

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Lidocaine - FDA Drug Approval Details