lidocaine hydrochloride

Generic: lidocaine hydrochloride

Labeler: novagenix labs llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lidocaine hydrochloride
Generic Name lidocaine hydrochloride
Labeler novagenix labs llc
Dosage Form SOLUTION
Routes
INTRAVENOUS
Active Ingredients

lidocaine hydrochloride 10 mg/mL

Manufacturer
Novagenix Labs LLC

Identifiers & Regulatory

Product NDC 84769-0001
Product ID 84769-0001_302f313a-e838-a040-e063-6394a90ae806
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212821
Listing Expiration 2026-12-31
Marketing Start 2025-03-31

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 847690001
Hyphenated Format 84769-0001

Supplemental Identifiers

RxCUI
1737566 1737761
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 ANDA212821 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 10 VIAL, SINGLE-DOSE in 1 BOX (84769-0001-2) / 5 mL in 1 VIAL, SINGLE-DOSE (84769-0001-1)
source: ndc

Packages (1)

84769-0001-2 10 VIAL, SINGLE-DOSE in 1 BOX (84769-0001-2) / 5 mL in 1 VIAL, SINGLE-DOSE (84769-0001-1)

Ingredients (1)

lidocaine hydrochloride (10 mg/mL)

Linked Drug Pages (1)

Lidocaine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "302f313a-e838-a040-e063-6394a90ae806", "openfda": {"unii": ["V13007Z41A"], "rxcui": ["1737566", "1737761"], "spl_set_id": ["7567ffb5-953a-4be9-9a02-c5a50dcd9306"], "manufacturer_name": ["Novagenix Labs LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 BOX (84769-0001-2)  / 5 mL in 1 VIAL, SINGLE-DOSE (84769-0001-1)", "package_ndc": "84769-0001-2", "marketing_start_date": "20250331"}], "brand_name": "Lidocaine Hydrochloride", "product_id": "84769-0001_302f313a-e838-a040-e063-6394a90ae806", "dosage_form": "SOLUTION", "pharm_class": ["Amide Local Anesthetic [EPC]", "Amides [CS]", "Antiarrhythmic [EPC]", "Local Anesthesia [PE]"], "product_ndc": "84769-0001", "generic_name": "lidocaine hydrochloride", "labeler_name": "Novagenix Labs LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lidocaine Hydrochloride", "active_ingredients": [{"name": "LIDOCAINE HYDROCHLORIDE", "strength": "10 mg/mL"}], "application_number": "ANDA212821", "marketing_category": "ANDA", "marketing_start_date": "20250331", "listing_expiration_date": "20261231"}