lidocaine

Generic: lidocaine

Labeler: advanced rx of tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lidocaine
Generic Name lidocaine
Labeler advanced rx of tennessee, llc
Dosage Form OINTMENT
Routes
TOPICAL
Active Ingredients

lidocaine 50 mg/g

Manufacturer
Advanced Rx of Tennessee, LLC

Identifiers & Regulatory

Product NDC 80425-0538
Product ID 80425-0538_3a9aed71-0064-6931-e063-6294a90a0957
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA086724
Listing Expiration 2026-12-31
Marketing Start 2025-07-23

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 804250538
Hyphenated Format 80425-0538

Supplemental Identifiers

RxCUI
1543069
UNII
98PI200987
NUI
N0000175682 M0000897 N0000175426 N0000175976

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 (source: ndc)
Generic Name lidocaine (source: ndc)
Application Number ANDA086724 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/g
source: ndc
Packaging
  • 1 JAR in 1 CARTON (80425-0538-1) / 50 g in 1 JAR
source: ndc

Packages (1)

80425-0538-1 1 JAR in 1 CARTON (80425-0538-1) / 50 g in 1 JAR

Ingredients (1)

lidocaine (50 mg/g)

Linked Drug Pages (1)

Lidocaine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "3a9aed71-0064-6931-e063-6294a90a0957", "openfda": {"nui": ["N0000175682", "M0000897", "N0000175426", "N0000175976"], "unii": ["98PI200987"], "rxcui": ["1543069"], "spl_set_id": ["3a9a6630-e470-b794-e063-6394a90aaab5"], "pharm_class_cs": ["Amides [CS]"], "pharm_class_pe": ["Local Anesthesia [PE]"], "pharm_class_epc": ["Amide Local Anesthetic [EPC]", "Antiarrhythmic [EPC]"], "manufacturer_name": ["Advanced Rx of Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "1 JAR in 1 CARTON (80425-0538-1)  / 50 g in 1 JAR", "package_ndc": "80425-0538-1", "marketing_start_date": "20250723"}], "brand_name": "Lidocaine", "product_id": "80425-0538_3a9aed71-0064-6931-e063-6294a90a0957", "dosage_form": "OINTMENT", "pharm_class": ["Amide Local Anesthetic [EPC]", "Amides [CS]", "Antiarrhythmic [EPC]", "Local Anesthesia [PE]"], "product_ndc": "80425-0538", "generic_name": "Lidocaine", "labeler_name": "Advanced Rx of Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lidocaine", "active_ingredients": [{"name": "LIDOCAINE", "strength": "50 mg/g"}], "application_number": "ANDA086724", "marketing_category": "ANDA", "marketing_start_date": "20250723", "listing_expiration_date": "20261231"}