xylocaine mpf

Generic: lidocaine hydrochloride,epinephrine bitartrate

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name xylocaine mpf
Generic Name lidocaine hydrochloride,epinephrine bitartrate
Labeler fresenius kabi usa, llc
Dosage Form INJECTION, SOLUTION
Routes
EPIDURAL INFILTRATION INTRACAUDAL PERINEURAL
Active Ingredients

epinephrine bitartrate .005 mg/mL, lidocaine hydrochloride anhydrous 15 mg/mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-488
Product ID 63323-488_ea480a68-5927-4278-9deb-2956961da428
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 63323488
Hyphenated Format 63323-488

Supplemental Identifiers

RxCUI
1010033 1010035 1010671 1010673 1010688 1010692 1010745 1010749 1010751 1010755 1010759 1010763 1010900 1010902 1737343 1737345 1737562 1737563 1737566 1737567 1737568 1737569 1737570 1737571 1737757 1737758 1737761 1737762 1867938 1867940 1867943 1867944 1867992 1867993 1867996 1867997 1868028 1868029
UPC
0363323484576 0363323485016 0363323483036 0363323487072 0363323486013 0363323495091 0363323488079 0363323489021 0363323495046 0363323491017 0363323492045 0363323492090 0363323482015 0363323481018
UNII
30Q7KI53AK EC2CNF7XFP

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 mpf (source: ndc)
Generic Name lidocaine hydrochloride,epinephrine bitartrate (source: ndc)
Application Number NDA006488 (source: ndc)
Routes
EPIDURAL INFILTRATION INTRACAUDAL PERINEURAL
source: ndc

Resolved Composition

Strengths
  • .005 mg/mL
  • 15 mg/mL
source: ndc
Packaging
  • 25 VIAL, SINGLE-DOSE in 1 TRAY (63323-488-17) / 10 mL in 1 VIAL, SINGLE-DOSE (63323-488-01)
  • 5 VIAL, SINGLE-DOSE in 1 CARTON (63323-488-31) / 30 mL in 1 VIAL, SINGLE-DOSE (63323-488-03)
  • 25 VIAL, SINGLE-DOSE in 1 TRAY (63323-488-37) / 30 mL in 1 VIAL, SINGLE-DOSE (63323-488-07)
source: ndc

Packages (3)

63323-488-17 25 VIAL, SINGLE-DOSE in 1 TRAY (63323-488-17) / 10 mL in 1 VIAL, SINGLE-DOSE (63323-488-01) 63323-488-31 5 VIAL, SINGLE-DOSE in 1 CARTON (63323-488-31) / 30 mL in 1 VIAL, SINGLE-DOSE (63323-488-03) 63323-488-37 25 VIAL, SINGLE-DOSE in 1 TRAY (63323-488-37) / 30 mL in 1 VIAL, SINGLE-DOSE (63323-488-07)

Ingredients (2)

epinephrine bitartrate (.005 mg/mL) lidocaine hydrochloride anhydrous (15 mg/mL)

Linked Drug Pages (1)

Xylocaine, Xylocaine MPF ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["EPIDURAL", "INFILTRATION", "INTRACAUDAL", "PERINEURAL"], "spl_id": "ea480a68-5927-4278-9deb-2956961da428", "openfda": {"upc": ["0363323484576", "0363323485016", "0363323483036", "0363323487072", "0363323486013", "0363323495091", "0363323488079", "0363323489021", "0363323495046", "0363323491017", "0363323492045", "0363323492090", "0363323482015", "0363323481018"], "unii": ["30Q7KI53AK", "EC2CNF7XFP"], "rxcui": ["1010033", "1010035", "1010671", "1010673", "1010688", "1010692", "1010745", "1010749", "1010751", "1010755", "1010759", "1010763", "1010900", "1010902", "1737343", "1737345", "1737562", "1737563", "1737566", "1737567", "1737568", "1737569", "1737570", "1737571", "1737757", "1737758", "1737761", "1737762", "1867938", "1867940", "1867943", "1867944", "1867992", "1867993", "1867996", "1867997", "1868028", "1868029"], "spl_set_id": ["ba082c2f-64f4-419d-9c88-74f203316e17"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL, SINGLE-DOSE in 1 TRAY (63323-488-17)  / 10 mL in 1 VIAL, SINGLE-DOSE (63323-488-01)", "package_ndc": "63323-488-17", "marketing_start_date": "20100812"}, {"sample": false, "description": "5 VIAL, SINGLE-DOSE in 1 CARTON (63323-488-31)  / 30 mL in 1 VIAL, SINGLE-DOSE (63323-488-03)", "package_ndc": "63323-488-31", "marketing_start_date": "20100812"}, {"sample": false, "description": "25 VIAL, SINGLE-DOSE in 1 TRAY (63323-488-37)  / 30 mL in 1 VIAL, SINGLE-DOSE (63323-488-07)", "package_ndc": "63323-488-37", "marketing_start_date": "20100812"}], "brand_name": "Xylocaine MPF", "product_id": "63323-488_ea480a68-5927-4278-9deb-2956961da428", "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": "63323-488", "generic_name": "LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Xylocaine", "brand_name_suffix": "MPF", "active_ingredients": [{"name": "EPINEPHRINE BITARTRATE", "strength": ".005 mg/mL"}, {"name": "LIDOCAINE HYDROCHLORIDE ANHYDROUS", "strength": "15 mg/mL"}], "application_number": "NDA006488", "marketing_category": "NDA", "marketing_start_date": "20100812", "listing_expiration_date": "20261231"}