lidocaine

Generic: lidocaine hydrochloride

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name lidocaine
Generic Name lidocaine hydrochloride
Labeler fresenius kabi usa, llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

lidocaine hydrochloride 20 mg/mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-208
Product ID 63323-208_289524c2-d0be-443d-aedf-39d621f217a5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA017584
Listing Expiration 2026-12-31
Marketing Start 2000-09-05

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 63323208
Hyphenated Format 63323-208

Supplemental Identifiers

RxCUI
1737761
UPC
0363323208011
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 (source: ndc)
Generic Name lidocaine hydrochloride (source: ndc)
Application Number NDA017584 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 20 mg/mL
source: ndc
Packaging
  • 25 VIAL, SINGLE-DOSE in 1 TRAY (63323-208-05) / 5 mL in 1 VIAL, SINGLE-DOSE (63323-208-01)
source: ndc

Packages (1)

63323-208-05 25 VIAL, SINGLE-DOSE in 1 TRAY (63323-208-05) / 5 mL in 1 VIAL, SINGLE-DOSE (63323-208-01)

Ingredients (1)

lidocaine hydrochloride (20 mg/mL)

Linked Drug Pages (1)

Lidocaine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "289524c2-d0be-443d-aedf-39d621f217a5", "openfda": {"upc": ["0363323208011"], "unii": ["V13007Z41A"], "rxcui": ["1737761"], "spl_set_id": ["f1b26274-a55e-4321-b96c-ce0df830f205"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL, SINGLE-DOSE in 1 TRAY (63323-208-05)  / 5 mL in 1 VIAL, SINGLE-DOSE (63323-208-01)", "package_ndc": "63323-208-05", "marketing_start_date": "20000905"}], "brand_name": "Lidocaine", "product_id": "63323-208_289524c2-d0be-443d-aedf-39d621f217a5", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Amide Local Anesthetic [EPC]", "Amides [CS]", "Antiarrhythmic [EPC]", "Local Anesthesia [PE]"], "product_ndc": "63323-208", "generic_name": "LIDOCAINE HYDROCHLORIDE", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lidocaine", "active_ingredients": [{"name": "LIDOCAINE HYDROCHLORIDE", "strength": "20 mg/mL"}], "application_number": "NDA017584", "marketing_category": "NDA", "marketing_start_date": "20000905", "listing_expiration_date": "20261231"}