lidocaine 5%

Generic: lidocaine 5%

Labeler: yaral pharma inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lidocaine 5%
Generic Name lidocaine 5%
Labeler yaral pharma inc.
Dosage Form PATCH
Routes
TOPICAL
Active Ingredients

lidocaine 50 mg/g

Manufacturer
YARAL Pharma Inc.

Identifiers & Regulatory

Product NDC 82347-0505
Product ID 82347-0505_47a77682-dfdc-1f00-e063-6294a90ac52c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209190
Listing Expiration 2027-12-31
Marketing Start 2023-06-15

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 823470505
Hyphenated Format 82347-0505

Supplemental Identifiers

RxCUI
1745091
UPC
0382347050550
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% (source: ndc)
Generic Name lidocaine 5% (source: ndc)
Application Number ANDA209190 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/g
source: ndc
Packaging
  • 30 POUCH in 1 PACKAGE (82347-0505-5) / 14 g in 1 POUCH (82347-0505-4)
source: ndc

Packages (1)

82347-0505-5 30 POUCH in 1 PACKAGE (82347-0505-5) / 14 g in 1 POUCH (82347-0505-4)

Ingredients (1)

lidocaine (50 mg/g)

Linked Drug Pages (1)

Lidocaine 5% ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "47a77682-dfdc-1f00-e063-6294a90ac52c", "openfda": {"nui": ["N0000175682", "M0000897", "N0000175426", "N0000175976"], "upc": ["0382347050550"], "unii": ["98PI200987"], "rxcui": ["1745091"], "spl_set_id": ["fc495fc8-15d6-27c7-e053-6394a90ab30d"], "pharm_class_cs": ["Amides [CS]"], "pharm_class_pe": ["Local Anesthesia [PE]"], "pharm_class_epc": ["Amide Local Anesthetic [EPC]", "Antiarrhythmic [EPC]"], "manufacturer_name": ["YARAL Pharma Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 POUCH in 1 PACKAGE (82347-0505-5)  / 14 g in 1 POUCH (82347-0505-4)", "package_ndc": "82347-0505-5", "marketing_start_date": "20230615"}], "brand_name": "Lidocaine 5%", "product_id": "82347-0505_47a77682-dfdc-1f00-e063-6294a90ac52c", "dosage_form": "PATCH", "pharm_class": ["Amide Local Anesthetic [EPC]", "Amides [CS]", "Antiarrhythmic [EPC]", "Local Anesthesia [PE]"], "product_ndc": "82347-0505", "generic_name": "Lidocaine 5%", "labeler_name": "YARAL Pharma Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lidocaine 5%", "active_ingredients": [{"name": "LIDOCAINE", "strength": "50 mg/g"}], "application_number": "ANDA209190", "marketing_category": "ANDA", "marketing_start_date": "20230615", "listing_expiration_date": "20271231"}