xylocaine

Generic: xylocaine

Labeler: hf acquisition co llc, dba healthfirst
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name xylocaine
Generic Name xylocaine
Labeler hf acquisition co llc, dba healthfirst
Dosage Form INJECTION, SOLUTION
Routes
INFILTRATION PERINEURAL
Active Ingredients

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

Manufacturer
HF Acquisition Co LLC, DBA HealthFirst

Identifiers & Regulatory

Product NDC 51662-1622
Product ID 51662-1622_199a3180-9d2b-2308-e063-6294a90ae9fd
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 516621622
Hyphenated Format 51662-1622

Supplemental Identifiers

RxCUI
1010751
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 xylocaine (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 POUCH in 1 CASE (51662-1622-3) / 1 VIAL, MULTI-DOSE in 1 POUCH (51662-1622-2) / 10 mL in 1 VIAL, MULTI-DOSE (51662-1622-1)
source: ndc

Packages (1)

51662-1622-3 25 POUCH in 1 CASE (51662-1622-3) / 1 VIAL, MULTI-DOSE in 1 POUCH (51662-1622-2) / 10 mL in 1 VIAL, MULTI-DOSE (51662-1622-1)

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": "199a3180-9d2b-2308-e063-6294a90ae9fd", "openfda": {"unii": ["30Q7KI53AK", "EC2CNF7XFP"], "rxcui": ["1010751"], "spl_set_id": ["17e77013-f2a0-b1f7-e063-6294a90ae468"], "manufacturer_name": ["HF Acquisition Co LLC, DBA HealthFirst"]}, "finished": true, "packaging": [{"sample": false, "description": "25 POUCH in 1 CASE (51662-1622-3)  / 1 VIAL, MULTI-DOSE in 1 POUCH (51662-1622-2)  / 10 mL in 1 VIAL, MULTI-DOSE (51662-1622-1)", "package_ndc": "51662-1622-3", "marketing_start_date": "20100812"}], "brand_name": "XYLOCAINE", "product_id": "51662-1622_199a3180-9d2b-2308-e063-6294a90ae9fd", "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": "51662-1622", "generic_name": "XYLOCAINE", "labeler_name": "HF Acquisition Co LLC, DBA HealthFirst", "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"}