lidocaine hydrochloride

Generic: lidocaine hydrochloride

Labeler: international medication systems, limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lidocaine hydrochloride
Generic Name lidocaine hydrochloride
Labeler international medication systems, limited
Dosage Form JELLY
Routes
TOPICAL
Active Ingredients

lidocaine hydrochloride 20 mg/mL

Manufacturer
International Medication Systems, Limited

Identifiers & Regulatory

Product NDC 76329-3011
Product ID 76329-3011_483019ba-e338-42f2-82da-2401e40e417c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA086283
Listing Expiration 2026-12-31
Marketing Start 1979-08-07

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 763293011
Hyphenated Format 76329-3011

Supplemental Identifiers

RxCUI
1011852
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 ANDA086283 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/mL
source: ndc
Packaging
  • 25 VIAL, SINGLE-USE in 1 BOX (76329-3011-5) / 5 mL in 1 VIAL, SINGLE-USE
source: ndc

Packages (1)

76329-3011-5 25 VIAL, SINGLE-USE in 1 BOX (76329-3011-5) / 5 mL in 1 VIAL, SINGLE-USE

Ingredients (1)

lidocaine hydrochloride (20 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": "483019ba-e338-42f2-82da-2401e40e417c", "openfda": {"unii": ["V13007Z41A"], "rxcui": ["1011852"], "spl_set_id": ["0cbc37d3-c2d6-4747-9834-7c23b38fcc20"], "manufacturer_name": ["International Medication Systems, Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL, SINGLE-USE in 1 BOX (76329-3011-5)  / 5 mL in 1 VIAL, SINGLE-USE", "package_ndc": "76329-3011-5", "marketing_start_date": "19790807"}], "brand_name": "Lidocaine Hydrochloride", "product_id": "76329-3011_483019ba-e338-42f2-82da-2401e40e417c", "dosage_form": "JELLY", "pharm_class": ["Amide Local Anesthetic [EPC]", "Amides [CS]", "Antiarrhythmic [EPC]", "Local Anesthesia [PE]"], "product_ndc": "76329-3011", "generic_name": "Lidocaine Hydrochloride", "labeler_name": "International Medication Systems, Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lidocaine Hydrochloride", "active_ingredients": [{"name": "LIDOCAINE HYDROCHLORIDE", "strength": "20 mg/mL"}], "application_number": "ANDA086283", "marketing_category": "ANDA", "marketing_start_date": "19790807", "listing_expiration_date": "20261231"}