xylocaine

Generic: lidocaine hydrochloride, epinephrine bitartrate injection, solution

Labeler: henry schein, inc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name xylocaine
Generic Name lidocaine hydrochloride, epinephrine bitartrate injection, solution
Labeler henry schein, inc
Dosage Form INJECTION, SOLUTION
Routes
INFILTRATION PERINEURAL
Active Ingredients

epinephrine bitartrate .005 mg/mL, lidocaine hydrochloride anhydrous 5 mg/mL

Manufacturer
Henry Schein, Inc

Identifiers & Regulatory

Product NDC 0404-9975
Product ID 0404-9975_d3bb4e49-d2c4-49be-b897-e7198382cf0d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA006488
Listing Expiration 2026-12-31
Marketing Start 2022-01-10

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 04049975
Hyphenated Format 0404-9975

Supplemental Identifiers

RxCUI
1010745 1010749
UNII
30Q7KI53AK EC2CNF7XFP

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 injection, solution (source: ndc)
Application Number NDA006488 (source: ndc)
Routes
INFILTRATION PERINEURAL
source: ndc

Resolved Composition

Strengths
  • .005 mg/mL
  • 5 mg/mL
source: ndc
Packaging
  • 1 VIAL in 1 BAG (0404-9975-50) / 50 mL in 1 VIAL
source: ndc

Packages (1)

0404-9975-50 1 VIAL in 1 BAG (0404-9975-50) / 50 mL in 1 VIAL

Ingredients (2)

epinephrine bitartrate (.005 mg/mL) lidocaine hydrochloride anhydrous (5 mg/mL)

Linked Drug Pages (1)

Xylocaine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INFILTRATION", "PERINEURAL"], "spl_id": "d3bb4e49-d2c4-49be-b897-e7198382cf0d", "openfda": {"unii": ["30Q7KI53AK", "EC2CNF7XFP"], "rxcui": ["1010745", "1010749"], "spl_set_id": ["9e8d0318-b2fe-4084-aedf-de97f61605a8"], "manufacturer_name": ["Henry Schein, Inc"]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 BAG (0404-9975-50)  / 50 mL in 1 VIAL", "package_ndc": "0404-9975-50", "marketing_start_date": "20220110"}], "brand_name": "Xylocaine", "product_id": "0404-9975_d3bb4e49-d2c4-49be-b897-e7198382cf0d", "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": "0404-9975", "generic_name": "Lidocaine hydrochloride, epinephrine bitartrate injection, solution", "labeler_name": "Henry Schein, Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Xylocaine", "active_ingredients": [{"name": "EPINEPHRINE BITARTRATE", "strength": ".005 mg/mL"}, {"name": "LIDOCAINE HYDROCHLORIDE ANHYDROUS", "strength": "5 mg/mL"}], "application_number": "NDA006488", "marketing_category": "NDA", "marketing_start_date": "20220110", "listing_expiration_date": "20261231"}