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Lidocaine

Lidocaine Ointment USP, 5%

Approved
Approval ID

5e05fbdf-3495-48e5-bdf4-188c069dd1f8

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jul 11, 2023

Manufacturers
FDA

UNIT DOSE SERVICES

DUNS: 831995316

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 Code50436-0474
Application NumberANDA210958
Product Classification
M
Marketing Category
C73584
G
Generic Name
lidocaine
Product Specifications
Route of AdministrationTOPICAL
Effective DateJuly 11, 2023
FDA Product Classification

INGREDIENTS (3)

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

Drug Labeling Information

HOW SUPPLIED SECTION

LOINC: 34069-5Updated: 7/11/2023

HOW SUPPLIED

Lidocaine Ointment USP, 5% is supplied as a white to off white translucent, homogenous ointment, free of lumps and foreign matter and available in the following packs:

NDC 50436-0474-1 LIDOCAINE OINTMENT USP, 5% /50 GRM

Store at 20º to 25ºC (68º to 77ºF); excursions permitted between 15º to 30ºC (59º to 86ºF) [See USP Controlled Room Temperature].

** Manufactured by:**
Strides Pharma Science Limited.
Bengaluru, India.

** Distributed by:**
Strides Pharma Inc.,
East Brunswick, NJ 08816

Revised: 11/2018

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Lidocaine - FDA Drug Approval Details