lidocaine 5% patch (82461-611)

Drug Facts

Product Profile

Brand Name lidocaine 5% patch

Generic Name lidocaine 5%

Labeler medcore llc

Dosage Form PATCH

Routes

TOPICAL

Active Ingredients

lidocaine 700 mg/1

Manufacturer

Medcore LLC

Identifiers & Regulatory

Product NDC 82461-611

Product ID 82461-611_3133aeac-f306-4b39-92d8-d7bc83ed65a3

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA209190

Listing Expiration 2027-12-31

Marketing Start 2024-09-09

Pharmacologic Class

Established (EPC)

amide local anesthetic [epc] antiarrhythmic [epc]

Chemical Structure

amides [cs]

Physiologic Effect

local anesthesia [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 82461611

Hyphenated Format 82461-611

Supplemental Identifiers

RxCUI

1745091

UNII

98PI200987

NUI

N0000175682 M0000897 N0000175426 N0000175976

Packaging Origin

Original Packager

true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name lidocaine 5% patch (source: ndc)

Generic Name lidocaine 5% (source: ndc)

Application Number ANDA209190 (source: ndc)

Routes

TOPICAL

source: ndc

Resolved Composition

Strengths

700 mg/1

source: ndc

Packaging

15 POUCH in 1 PACKAGE (82461-611-15) / 1 PATCH in 1 POUCH (82461-611-01)

source: ndc

Packages (1)

82461-611-15 15 POUCH in 1 PACKAGE (82461-611-15) / 1 PATCH in 1 POUCH (82461-611-01)

Ingredients (1)

lidocaine (700 mg/1)

Linked Drug Pages (1)

Lidocaine 5% Patch ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["TOPICAL"], "spl_id": "3133aeac-f306-4b39-92d8-d7bc83ed65a3", "openfda": {"nui": ["N0000175682", "M0000897", "N0000175426", "N0000175976"], "unii": ["98PI200987"], "rxcui": ["1745091"], "spl_set_id": ["1afe428f-e223-4ef8-a6ba-968f4cfbf476"], "pharm_class_cs": ["Amides [CS]"], "pharm_class_pe": ["Local Anesthesia [PE]"], "pharm_class_epc": ["Amide Local Anesthetic [EPC]", "Antiarrhythmic [EPC]"], "manufacturer_name": ["Medcore LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "15 POUCH in 1 PACKAGE (82461-611-15)  / 1 PATCH in 1 POUCH (82461-611-01)", "package_ndc": "82461-611-15", "marketing_start_date": "20240909"}], "brand_name": "Lidocaine 5% Patch", "product_id": "82461-611_3133aeac-f306-4b39-92d8-d7bc83ed65a3", "dosage_form": "PATCH", "pharm_class": ["Amide Local Anesthetic [EPC]", "Amides [CS]", "Antiarrhythmic [EPC]", "Local Anesthesia [PE]"], "product_ndc": "82461-611", "generic_name": "Lidocaine 5%", "labeler_name": "Medcore LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lidocaine 5% Patch", "active_ingredients": [{"name": "LIDOCAINE", "strength": "700 mg/1"}], "application_number": "ANDA209190", "marketing_category": "ANDA", "marketing_start_date": "20240909", "listing_expiration_date": "20271231"}