xylocaine

Generic: lidocaine hydrochloride and epinephrine

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

Drug Facts

Product Profile

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

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

Manufacturer
Henry Schein, Inc.

Identifiers & Regulatory

Product NDC 0404-9977
Product ID 0404-9977_31b79501-6c6b-4247-851a-8dfc25f6c681
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 04049977
Hyphenated Format 0404-9977

Supplemental Identifiers

RxCUI
1010751 1010755
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 and epinephrine (source: ndc)
Application Number NDA006488 (source: ndc)
Routes
INFILTRATION PERINEURAL
source: ndc

Resolved Composition

Strengths
  • .01 mg/mL
  • 10 mg/mL
source: ndc
Packaging
  • 1 VIAL in 1 BAG (0404-9977-20) / 20 mL in 1 VIAL
  • 1 VIAL in 1 BAG (0404-9977-50) / 50 mL in 1 VIAL
source: ndc

Packages (2)

0404-9977-20 1 VIAL in 1 BAG (0404-9977-20) / 20 mL in 1 VIAL 0404-9977-50 1 VIAL in 1 BAG (0404-9977-50) / 50 mL in 1 VIAL

Ingredients (2)

epinephrine bitartrate (.01 mg/mL) lidocaine hydrochloride anhydrous (10 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": "31b79501-6c6b-4247-851a-8dfc25f6c681", "openfda": {"unii": ["30Q7KI53AK", "EC2CNF7XFP"], "rxcui": ["1010751", "1010755"], "spl_set_id": ["27c2e78d-d037-470d-b4fa-44c33d78f788"], "manufacturer_name": ["Henry Schein, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 BAG (0404-9977-20)  / 20 mL in 1 VIAL", "package_ndc": "0404-9977-20", "marketing_start_date": "20220110"}, {"sample": false, "description": "1 VIAL in 1 BAG (0404-9977-50)  / 50 mL in 1 VIAL", "package_ndc": "0404-9977-50", "marketing_start_date": "20220110"}], "brand_name": "Xylocaine", "product_id": "0404-9977_31b79501-6c6b-4247-851a-8dfc25f6c681", "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": "0404-9977", "generic_name": "Lidocaine Hydrochloride and Epinephrine", "labeler_name": "Henry Schein, Inc.", "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": "20220110", "listing_expiration_date": "20261231"}