lidocaine hydrochloride

Generic: lidocaine hydrochloride

Labeler: pai holdings, llc dba pai pharma
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lidocaine hydrochloride
Generic Name lidocaine hydrochloride
Labeler pai holdings, llc dba pai pharma
Dosage Form SOLUTION
Routes
TOPICAL
Active Ingredients

lidocaine hydrochloride 40 mg/mL

Manufacturer
PAI Holdings, LLC dba PAI Pharma

Identifiers & Regulatory

Product NDC 0121-0972
Product ID 0121-0972_a8761ec7-33e3-43fe-bb07-5e6144a8926e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204494
Listing Expiration 2026-12-31
Marketing Start 2023-07-31

Pharmacologic Class

Classes
amide local anesthetic [epc] amides [cs] antiarrhythmic [epc] local anesthesia [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01210972
Hyphenated Format 0121-0972

Supplemental Identifiers

RxCUI
1010878
UPC
0301210972515
UNII
V13007Z41A

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 hydrochloride (source: ndc)
Generic Name lidocaine hydrochloride (source: ndc)
Application Number ANDA204494 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, GLASS in 1 CARTON (0121-0972-51) / 50 mL in 1 BOTTLE, GLASS
source: ndc

Packages (1)

0121-0972-51 1 BOTTLE, GLASS in 1 CARTON (0121-0972-51) / 50 mL in 1 BOTTLE, GLASS

Ingredients (1)

lidocaine hydrochloride (40 mg/mL)

Linked Drug Pages (1)

Lidocaine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "a8761ec7-33e3-43fe-bb07-5e6144a8926e", "openfda": {"upc": ["0301210972515"], "unii": ["V13007Z41A"], "rxcui": ["1010878"], "spl_set_id": ["9920daef-b156-4a14-b641-f714191ffb5c"], "manufacturer_name": ["PAI Holdings, LLC dba PAI Pharma"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, GLASS in 1 CARTON (0121-0972-51)  / 50 mL in 1 BOTTLE, GLASS", "package_ndc": "0121-0972-51", "marketing_start_date": "20230731"}], "brand_name": "Lidocaine Hydrochloride", "product_id": "0121-0972_a8761ec7-33e3-43fe-bb07-5e6144a8926e", "dosage_form": "SOLUTION", "pharm_class": ["Amide Local Anesthetic [EPC]", "Amides [CS]", "Antiarrhythmic [EPC]", "Local Anesthesia [PE]"], "product_ndc": "0121-0972", "generic_name": "Lidocaine Hydrochloride", "labeler_name": "PAI Holdings, LLC dba PAI Pharma", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lidocaine Hydrochloride", "active_ingredients": [{"name": "LIDOCAINE HYDROCHLORIDE", "strength": "40 mg/mL"}], "application_number": "ANDA204494", "marketing_category": "ANDA", "marketing_start_date": "20230731", "listing_expiration_date": "20261231"}