lidocaine

Generic: lidocaine

Labeler: fougera pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lidocaine
Generic Name lidocaine
Labeler fougera pharmaceuticals, llc
Dosage Form OINTMENT
Routes
TOPICAL
Active Ingredients

lidocaine 50 mg/g

Manufacturer
Fougera Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 0168-0204
Product ID 0168-0204_76e9f389-e9f0-4568-8b13-74c9dd831001
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA080198
Listing Expiration 2027-12-31
Marketing Start 1972-06-30

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 01680204
Hyphenated Format 0168-0204

Supplemental Identifiers

RxCUI
1543069
UPC
0301680204376
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 (source: ndc)
Generic Name lidocaine (source: ndc)
Application Number ANDA080198 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (0168-0204-37) / 35.44 g in 1 TUBE
source: ndc

Packages (1)

0168-0204-37 1 TUBE in 1 CARTON (0168-0204-37) / 35.44 g in 1 TUBE

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": "76e9f389-e9f0-4568-8b13-74c9dd831001", "openfda": {"nui": ["N0000175682", "M0000897", "N0000175426", "N0000175976"], "upc": ["0301680204376"], "unii": ["98PI200987"], "rxcui": ["1543069"], "spl_set_id": ["88ca9cba-0c4a-482f-b502-ceefdb1bfbcd"], "pharm_class_cs": ["Amides [CS]"], "pharm_class_pe": ["Local Anesthesia [PE]"], "pharm_class_epc": ["Amide Local Anesthetic [EPC]", "Antiarrhythmic [EPC]"], "manufacturer_name": ["Fougera Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (0168-0204-37)  / 35.44 g in 1 TUBE", "package_ndc": "0168-0204-37", "marketing_start_date": "19720630"}], "brand_name": "Lidocaine", "product_id": "0168-0204_76e9f389-e9f0-4568-8b13-74c9dd831001", "dosage_form": "OINTMENT", "pharm_class": ["Amide Local Anesthetic [EPC]", "Amides [CS]", "Antiarrhythmic [EPC]", "Local Anesthesia [PE]"], "product_ndc": "0168-0204", "generic_name": "Lidocaine", "labeler_name": "Fougera Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lidocaine", "active_ingredients": [{"name": "LIDOCAINE", "strength": "50 mg/g"}], "application_number": "ANDA080198", "marketing_category": "ANDA", "marketing_start_date": "19720630", "listing_expiration_date": "20271231"}