lidocaine hydrochloride

Generic: lidocaine hydrochloride

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lidocaine hydrochloride
Generic Name lidocaine hydrochloride
Labeler hikma pharmaceuticals usa inc.
Dosage Form SOLUTION
Routes
TOPICAL
Active Ingredients

lidocaine hydrochloride 40 mg/mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0054-3505
Product ID 0054-3505_3996fa01-1f0c-41ab-8dc3-9a28246138c8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA088803
Listing Expiration 2026-12-31
Marketing Start 1985-04-03

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 00543505
Hyphenated Format 0054-3505

Supplemental Identifiers

RxCUI
1010878
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 ANDA088803 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/mL
source: ndc
Packaging
  • 50 mL in 1 BOTTLE (0054-3505-47)
source: ndc

Packages (1)

0054-3505-47 50 mL in 1 BOTTLE (0054-3505-47)

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": "3996fa01-1f0c-41ab-8dc3-9a28246138c8", "openfda": {"unii": ["V13007Z41A"], "rxcui": ["1010878"], "spl_set_id": ["c5d27da0-e495-4bb6-a7e1-8eaa6595eb71"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "50 mL in 1 BOTTLE (0054-3505-47)", "package_ndc": "0054-3505-47", "marketing_start_date": "19850403"}], "brand_name": "Lidocaine Hydrochloride", "product_id": "0054-3505_3996fa01-1f0c-41ab-8dc3-9a28246138c8", "dosage_form": "SOLUTION", "pharm_class": ["Amide Local Anesthetic [EPC]", "Amides [CS]", "Antiarrhythmic [EPC]", "Local Anesthesia [PE]"], "product_ndc": "0054-3505", "generic_name": "Lidocaine Hydrochloride", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lidocaine Hydrochloride", "active_ingredients": [{"name": "LIDOCAINE HYDROCHLORIDE", "strength": "40 mg/mL"}], "application_number": "ANDA088803", "marketing_category": "ANDA", "marketing_start_date": "19850403", "listing_expiration_date": "20261231"}