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Lidocaine

Lidocaine Ointment USP, 5% FOR TOPICAL USEDO NOT USE IN THE EYES Rx Only

Approved
Approval ID

f8789807-cc0c-485c-aa98-1bdc39337deb

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Feb 15, 2023

Manufacturers
FDA

QUAGEN PHARMACEUTICALS LLC

DUNS: 073645339

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 Code70752-113
Application NumberANDA212695
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lidocaine
Product Specifications
Route of AdministrationTOPICAL
Effective DateFebruary 15, 2023
FDA Product Classification

INGREDIENTS (3)

LIDOCAINEActive
Quantity: 50 mg in 1 g
Code: 98PI200987
Classification: ACTIB
POLYETHYLENE GLYCOL 300Inactive
Code: 5655G9Y8AQ
Classification: IACT
POLYETHYLENE GLYCOL 1450Inactive
Code: OJ4Z5Z32L4
Classification: IACT

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Lidocaine - FDA Drug Approval Details