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lidocaine

Lidocaine Ointment, 5% for topical use DO NOT USE IN THE EYES Rx Only

Approved
Approval ID

cde68b0c-a1ee-421d-9ca8-bc571d2990ab

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 30, 2019

Manufacturers
FDA

Northstar Rx LLC

DUNS: 830546433

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 Code16714-878
Application NumberANDA206498
Product Classification
M
Marketing Category
C73584
G
Generic Name
lidocaine
Product Specifications
Route of AdministrationTOPICAL
Effective DateNovember 30, 2019
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