lidocaine hydrochloride

Generic: lidocaine hydrochloride

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lidocaine hydrochloride
Generic Name lidocaine hydrochloride
Labeler sun pharmaceutical industries, inc.
Dosage Form SOLUTION
Routes
TOPICAL
Active Ingredients

lidocaine hydrochloride 40 mg/mL

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 51672-1411
Product ID 51672-1411_39623a94-8b8c-17c6-e063-6294a90a4c31
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218182
Listing Expiration 2026-12-31
Marketing Start 2023-12-08

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 516721411
Hyphenated Format 51672-1411

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 ANDA218182 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (51672-1411-3) / 50 mL in 1 BOTTLE
source: ndc

Packages (1)

51672-1411-3 1 BOTTLE in 1 CARTON (51672-1411-3) / 50 mL in 1 BOTTLE

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": "39623a94-8b8c-17c6-e063-6294a90a4c31", "openfda": {"unii": ["V13007Z41A"], "rxcui": ["1010878"], "spl_set_id": ["845b96c1-36a3-431f-8316-112ae881d934"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (51672-1411-3)  / 50 mL in 1 BOTTLE", "package_ndc": "51672-1411-3", "marketing_start_date": "20231208"}], "brand_name": "Lidocaine Hydrochloride", "product_id": "51672-1411_39623a94-8b8c-17c6-e063-6294a90a4c31", "dosage_form": "SOLUTION", "pharm_class": ["Amide Local Anesthetic [EPC]", "Amides [CS]", "Antiarrhythmic [EPC]", "Local Anesthesia [PE]"], "product_ndc": "51672-1411", "generic_name": "Lidocaine Hydrochloride", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lidocaine Hydrochloride", "active_ingredients": [{"name": "LIDOCAINE HYDROCHLORIDE", "strength": "40 mg/mL"}], "application_number": "ANDA218182", "marketing_category": "ANDA", "marketing_start_date": "20231208", "listing_expiration_date": "20261231"}