xylocaine

Generic: lidocaine hydrochloride,epinephrine bitartrate

Labeler: remedyrepack inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

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

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

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-4152
Product ID 70518-4152_40bbf18f-8948-ef62-e063-6394a90aa2d2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA006488
Listing Expiration 2026-12-31
Marketing Start 2024-07-31

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 705184152
Hyphenated Format 70518-4152

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
  • 25 VIAL, MULTI-DOSE in 1 TRAY (70518-4152-1) / 20 mL in 1 VIAL, MULTI-DOSE (70518-4152-0)
  • 25 VIAL, MULTI-DOSE in 1 TRAY (70518-4152-2) / 50 mL in 1 VIAL, MULTI-DOSE (70518-4152-3)
source: ndc

Packages (2)

70518-4152-1 25 VIAL, MULTI-DOSE in 1 TRAY (70518-4152-1) / 20 mL in 1 VIAL, MULTI-DOSE (70518-4152-0) 70518-4152-2 25 VIAL, MULTI-DOSE in 1 TRAY (70518-4152-2) / 50 mL in 1 VIAL, MULTI-DOSE (70518-4152-3)

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": "40bbf18f-8948-ef62-e063-6394a90aa2d2", "openfda": {"unii": ["30Q7KI53AK", "EC2CNF7XFP"], "rxcui": ["1010751", "1010755"], "spl_set_id": ["1414bcfc-1543-4ad4-83bd-4fc444a02e92"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL, MULTI-DOSE in 1 TRAY (70518-4152-1)  / 20 mL in 1 VIAL, MULTI-DOSE (70518-4152-0)", "package_ndc": "70518-4152-1", "marketing_start_date": "20240731"}, {"sample": false, "description": "25 VIAL, MULTI-DOSE in 1 TRAY (70518-4152-2)  / 50 mL in 1 VIAL, MULTI-DOSE (70518-4152-3)", "package_ndc": "70518-4152-2", "marketing_start_date": "20241004"}], "brand_name": "Xylocaine", "product_id": "70518-4152_40bbf18f-8948-ef62-e063-6394a90aa2d2", "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": "70518-4152", "generic_name": "LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE", "labeler_name": "REMEDYREPACK 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": "20240731", "listing_expiration_date": "20261231"}