lidocaine

Generic: lidocaine hydrochloride

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

Drug Facts

Product Profile

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

lidocaine hydrochloride 10 mg/mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-201
Product ID 63323-201_d19c26f4-1214-40f7-9680-43c885613306
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA088586
Listing Expiration 2026-12-31
Marketing Start 2010-05-27

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 63323201
Hyphenated Format 63323-201

Supplemental Identifiers

RxCUI
1010033 1737757
UPC
0363323202019 0363323201036 0363323201012
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 ANDA088586 (source: ndc)
Routes
INFILTRATION PERINEURAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 25 VIAL in 1 TRAY (63323-201-02) / 2 mL in 1 VIAL (63323-201-01)
  • 25 VIAL in 1 TRAY (63323-201-10) / 10 mL in 1 VIAL (63323-201-03)
source: ndc

Packages (2)

63323-201-02 25 VIAL in 1 TRAY (63323-201-02) / 2 mL in 1 VIAL (63323-201-01) 63323-201-10 25 VIAL in 1 TRAY (63323-201-10) / 10 mL in 1 VIAL (63323-201-03)

Ingredients (1)

lidocaine hydrochloride (10 mg/mL)

Linked Drug Pages (1)

Lidocaine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INFILTRATION", "PERINEURAL"], "spl_id": "d19c26f4-1214-40f7-9680-43c885613306", "openfda": {"upc": ["0363323202019", "0363323201036", "0363323201012"], "unii": ["V13007Z41A"], "rxcui": ["1010033", "1737757"], "spl_set_id": ["cddb2b22-fce3-8967-6e54-dca3df5ac4b3"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL in 1 TRAY (63323-201-02)  / 2 mL in 1 VIAL (63323-201-01)", "package_ndc": "63323-201-02", "marketing_start_date": "20100527"}, {"sample": false, "description": "25 VIAL in 1 TRAY (63323-201-10)  / 10 mL in 1 VIAL (63323-201-03)", "package_ndc": "63323-201-10", "marketing_start_date": "20100527"}], "brand_name": "Lidocaine", "product_id": "63323-201_d19c26f4-1214-40f7-9680-43c885613306", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Amide Local Anesthetic [EPC]", "Amides [CS]", "Antiarrhythmic [EPC]", "Local Anesthesia [PE]"], "product_ndc": "63323-201", "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": "10 mg/mL"}], "application_number": "ANDA088586", "marketing_category": "ANDA", "marketing_start_date": "20100527", "listing_expiration_date": "20261231"}