xylocaine

Generic: lidocaine hydrochloride and epinephrine bitartrate

Labeler: dentsply pharmaceutical
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name xylocaine
Generic Name lidocaine hydrochloride and epinephrine bitartrate
Labeler dentsply pharmaceutical
Dosage Form INJECTION, SOLUTION
Routes
SUBMUCOSAL
Active Ingredients

epinephrine bitartrate 10 ug/mL, lidocaine hydrochloride 20 mg/mL

Manufacturer
Dentsply Pharmaceutical

Identifiers & Regulatory

Product NDC 66312-176
Product ID 66312-176_5b7b5a3e-e9fe-4dd1-949f-d3cac9755bb5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA088390
Listing Expiration 2026-12-31
Marketing Start 1985-01-22

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 66312176
Hyphenated Format 66312-176

Supplemental Identifiers

RxCUI
1010768 1293648 1608499 1657026
UNII
30Q7KI53AK V13007Z41A

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 and epinephrine bitartrate (source: ndc)
Application Number ANDA088390 (source: ndc)
Routes
SUBMUCOSAL
source: ndc

Resolved Composition

Strengths
  • 10 ug/mL
  • 20 mg/mL
source: ndc
Packaging
  • 50 CARTRIDGE in 1 CARTON (66312-176-16) / 1.7 mL in 1 CARTRIDGE
source: ndc

Packages (1)

66312-176-16 50 CARTRIDGE in 1 CARTON (66312-176-16) / 1.7 mL in 1 CARTRIDGE

Ingredients (2)

epinephrine bitartrate (10 ug/mL) lidocaine hydrochloride (20 mg/mL)

Linked Drug Pages (1)

Xylocaine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBMUCOSAL"], "spl_id": "5b7b5a3e-e9fe-4dd1-949f-d3cac9755bb5", "openfda": {"unii": ["30Q7KI53AK", "V13007Z41A"], "rxcui": ["1010768", "1293648", "1608499", "1657026"], "spl_set_id": ["14b55cf9-f7cd-4bb4-a7c5-aba61abadef1"], "manufacturer_name": ["Dentsply Pharmaceutical"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "50 CARTRIDGE in 1 CARTON (66312-176-16)  / 1.7 mL in 1 CARTRIDGE", "package_ndc": "66312-176-16", "marketing_start_date": "20090414"}], "brand_name": "Xylocaine", "product_id": "66312-176_5b7b5a3e-e9fe-4dd1-949f-d3cac9755bb5", "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": "66312-176", "generic_name": "Lidocaine Hydrochloride and Epinephrine Bitartrate", "labeler_name": "Dentsply Pharmaceutical", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Xylocaine", "active_ingredients": [{"name": "EPINEPHRINE BITARTRATE", "strength": "10 ug/mL"}, {"name": "LIDOCAINE HYDROCHLORIDE", "strength": "20 mg/mL"}], "application_number": "ANDA088390", "marketing_category": "ANDA", "marketing_start_date": "19850122", "listing_expiration_date": "20261231"}