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 SOLUTION
Routes
TOPICAL
Active Ingredients

lidocaine hydrochloride 40 mg/mL

Manufacturer
International Medication Systems, Limited

Identifiers & Regulatory

Product NDC 76329-6300
Product ID 76329-6300_8e30c3dd-67a2-4973-9325-1765b95c047d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA086364
Listing Expiration 2026-12-31
Marketing Start 2012-06-19

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 763296300
Hyphenated Format 76329-6300

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 ANDA086364 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/mL
source: ndc
Packaging
  • 25 VIAL in 1 CARTON (76329-6300-5) / 4 mL in 1 VIAL
source: ndc

Packages (1)

76329-6300-5 25 VIAL in 1 CARTON (76329-6300-5) / 4 mL in 1 VIAL

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": "8e30c3dd-67a2-4973-9325-1765b95c047d", "openfda": {"unii": ["V13007Z41A"], "rxcui": ["1010878"], "spl_set_id": ["2c48cfac-81eb-4a81-8590-bc94574dd4c3"], "manufacturer_name": ["International Medication Systems, Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL in 1 CARTON (76329-6300-5)  / 4 mL in 1 VIAL", "package_ndc": "76329-6300-5", "marketing_start_date": "20120619"}], "brand_name": "Lidocaine Hydrochloride", "product_id": "76329-6300_8e30c3dd-67a2-4973-9325-1765b95c047d", "dosage_form": "SOLUTION", "pharm_class": ["Amide Local Anesthetic [EPC]", "Amides [CS]", "Antiarrhythmic [EPC]", "Local Anesthesia [PE]"], "product_ndc": "76329-6300", "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": "40 mg/mL"}], "application_number": "ANDA086364", "marketing_category": "ANDA", "marketing_start_date": "20120619", "listing_expiration_date": "20261231"}