xylocaine

Generic: lidocaine hydrochloride,epinephrine bitartrate

Labeler: propharma distribution
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name xylocaine
Generic Name lidocaine hydrochloride,epinephrine bitartrate
Labeler propharma distribution
Dosage Form INJECTION, SOLUTION
Routes
INFILTRATION PERINEURAL
Active Ingredients

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

Manufacturer
ProPharma Distribution

Identifiers & Regulatory

Product NDC 84549-482
Product ID 84549-482_3a3870c9-9b0f-40e4-e063-6294a90a705d
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 84549482
Hyphenated Format 84549-482

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,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
  • 50 mL in 1 VIAL, MULTI-DOSE (84549-482-57)
source: ndc

Packages (1)

84549-482-57 50 mL in 1 VIAL, MULTI-DOSE (84549-482-57)

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": "3a3870c9-9b0f-40e4-e063-6294a90a705d", "openfda": {"unii": ["30Q7KI53AK", "EC2CNF7XFP"], "rxcui": ["1010751", "1010755"], "spl_set_id": ["386c23fd-1691-98b2-e063-6294a90ab070"], "manufacturer_name": ["ProPharma Distribution"]}, "finished": true, "packaging": [{"sample": false, "description": "50 mL in 1 VIAL, MULTI-DOSE (84549-482-57)", "package_ndc": "84549-482-57", "marketing_start_date": "20250827"}], "brand_name": "Xylocaine", "product_id": "84549-482_3a3870c9-9b0f-40e4-e063-6294a90a705d", "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": "84549-482", "generic_name": "LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE", "labeler_name": "ProPharma Distribution", "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"}