xylocaine

Generic: lidocaine hydrochloride,epinephrine bitartrate

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

Drug Facts

Product Profile

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

epinephrine bitartrate .01 mg/mL, lidocaine hydrochloride anhydrous 10 mg/mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-482
Product ID 63323-482_0ff12fe1-0ad7-4ae0-83bf-30f11e3adb33
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA006488
Listing Expiration 2026-12-31
Marketing Start 2010-08-12

Pharmacologic Class

Classes
adrenergic alpha-agonists [moa] adrenergic beta-agonists [moa] amide local anesthetic [epc] amides [cs] antiarrhythmic [epc] catecholamine [epc] catecholamines [cs] local anesthesia [pe] alpha-adrenergic agonist [epc] beta-adrenergic agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63323482
Hyphenated Format 63323-482

Supplemental Identifiers

RxCUI
1010033 1010035 1010671 1010673 1010751 1010755 1737562 1737563 1737566 1737567 1737568 1737569 1737570 1737571 1737757 1737758 1737761 1737762
UPC
0363323486419 0363323495411 0363323492434 0363323482411 0363323485412 0363323492458 0363323492410
UNII
30Q7KI53AK EC2CNF7XFP

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 xylocaine (source: ndc)
Generic Name lidocaine hydrochloride,epinephrine bitartrate (source: ndc)
Application Number NDA006488 (source: ndc)
Routes
INFILTRATION PERINEURAL
source: ndc

Resolved Composition

Strengths
  • .01 mg/mL
  • 10 mg/mL
source: ndc
Packaging
  • 25 VIAL, MULTI-DOSE in 1 TRAY (63323-482-26) / 20 mL in 1 VIAL, MULTI-DOSE (63323-482-41)
source: ndc

Packages (1)

63323-482-26 25 VIAL, MULTI-DOSE in 1 TRAY (63323-482-26) / 20 mL in 1 VIAL, MULTI-DOSE (63323-482-41)

Ingredients (2)

epinephrine bitartrate (.01 mg/mL) lidocaine hydrochloride anhydrous (10 mg/mL)

Linked Drug Pages (2)

Xylocaine, Xylocaine MPF ndc-match (0.9) Xylocaine, Xylocaine MPF ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INFILTRATION", "PERINEURAL"], "spl_id": "0ff12fe1-0ad7-4ae0-83bf-30f11e3adb33", "openfda": {"upc": ["0363323486419", "0363323495411", "0363323492434", "0363323482411", "0363323485412", "0363323492458", "0363323492410"], "unii": ["30Q7KI53AK", "EC2CNF7XFP"], "rxcui": ["1010033", "1010035", "1010671", "1010673", "1010751", "1010755", "1737562", "1737563", "1737566", "1737567", "1737568", "1737569", "1737570", "1737571", "1737757", "1737758", "1737761", "1737762"], "spl_set_id": ["4dd52202-8eef-4136-92dd-ada573b7cf74"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL, MULTI-DOSE in 1 TRAY (63323-482-26)  / 20 mL in 1 VIAL, MULTI-DOSE (63323-482-41)", "package_ndc": "63323-482-26", "marketing_start_date": "20100812"}], "brand_name": "Xylocaine", "product_id": "63323-482_0ff12fe1-0ad7-4ae0-83bf-30f11e3adb33", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Adrenergic alpha-Agonists [MoA]", "Adrenergic beta-Agonists [MoA]", "Amide Local Anesthetic [EPC]", "Amides [CS]", "Antiarrhythmic [EPC]", "Catecholamine [EPC]", "Catecholamines [CS]", "Local Anesthesia [PE]", "alpha-Adrenergic Agonist [EPC]", "beta-Adrenergic Agonist [EPC]"], "product_ndc": "63323-482", "generic_name": "LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Xylocaine", "active_ingredients": [{"name": "EPINEPHRINE BITARTRATE", "strength": ".01 mg/mL"}, {"name": "LIDOCAINE HYDROCHLORIDE ANHYDROUS", "strength": "10 mg/mL"}], "application_number": "NDA006488", "marketing_category": "NDA", "marketing_start_date": "20100812", "listing_expiration_date": "20261231"}