FDA.reportPublic FDA data

Xylocaine

Product NDC
65219-810
11-digit product format
652190810
Labeler code
65219
Product ID
65219-810_db90b9bc-09cb-4f67-8cde-bd7fc1394d17
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LIDOCAINE HYDROCHLORIDE
Dosage form
INJECTION, SOLUTION
Route
EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL
Labeler
Fresenius Kabi USA, LLC
Application
NDA006488
Marketing category
NDA
Marketing start
2020-10-30
Substance
LIDOCAINE HYDROCHLORIDE ANHYDROUS
Active strength
10 mg/mL
Pharmacologic classes
Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Xylocaine
Brand name suffix
MPF
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE HYDROCHLORIDE ANHYDROUS10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiEC2CNF7XFP
Rxcui1737568, 1737569, 1737757, 1737758, 1737761, 1737762

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65219-810-01XylocaineMPF2 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION23
65219-810-02XylocaineMPF25 in 1 TRAYINJECTION, SOLUTION253

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65219-810-01ML - Milliliter65219-81066fa3cf9-1650-4d5b-b2ae-17161abd8bf912025-05-14
65219-810-02ML - Milliliter65219-8107141a975-e280-4253-8655-f5a96c5d5d4912025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65219-810XYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]3Current NDC, Legacy NDC, 2 package rows20240328_fe265eb5-eaeb-4f47-82dd-238c1d53fec4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1737568lidocaine HCl 1 % in 2 ML InjectionPSNfe265eb5-eaeb-4f47-82dd-238c1d53fec43
1737757lidocaine HCl 2 % in 2 ML InjectionPSNfe265eb5-eaeb-4f47-82dd-238c1d53fec43
1737761lidocaine HCl 2 % in 5 ML InjectionPSNfe265eb5-eaeb-4f47-82dd-238c1d53fec43
1737569Xylocaine 1 % in 2 ML InjectionPSNfe265eb5-eaeb-4f47-82dd-238c1d53fec43
1737758Xylocaine 2 % in 2 ML InjectionPSNfe265eb5-eaeb-4f47-82dd-238c1d53fec43
1737762Xylocaine 2 % in 5 ML InjectionPSNfe265eb5-eaeb-4f47-82dd-238c1d53fec43
17375692 ML lidocaine hydrochloride 10 MG/ML Injection [Xylocaine]SBDfe265eb5-eaeb-4f47-82dd-238c1d53fec43
17377582 ML lidocaine hydrochloride 20 MG/ML Injection [Xylocaine]SBDfe265eb5-eaeb-4f47-82dd-238c1d53fec43
17377625 ML lidocaine hydrochloride 20 MG/ML Injection [Xylocaine]SBDfe265eb5-eaeb-4f47-82dd-238c1d53fec43
17375682 ML lidocaine hydrochloride 10 MG/ML InjectionSCDfe265eb5-eaeb-4f47-82dd-238c1d53fec43
17377572 ML lidocaine hydrochloride 20 MG/ML InjectionSCDfe265eb5-eaeb-4f47-82dd-238c1d53fec43
17377615 ML lidocaine hydrochloride 20 MG/ML InjectionSCDfe265eb5-eaeb-4f47-82dd-238c1d53fec43
17375692 ML Xylocaine 10 MG/ML InjectionSYfe265eb5-eaeb-4f47-82dd-238c1d53fec43
17377582 ML Xylocaine 20 MG/ML InjectionSYfe265eb5-eaeb-4f47-82dd-238c1d53fec43
17377625 ML Xylocaine 20 MG/ML InjectionSYfe265eb5-eaeb-4f47-82dd-238c1d53fec43
1737568lidocaine HCl 1 % per 2 ML InjectionSYfe265eb5-eaeb-4f47-82dd-238c1d53fec43
1737761lidocaine HCl 100 MG per 5 ML InjectionSYfe265eb5-eaeb-4f47-82dd-238c1d53fec43
1737757lidocaine HCl 2 % per 2 ML InjectionSYfe265eb5-eaeb-4f47-82dd-238c1d53fec43
1737761lidocaine HCl 2 % per 5 ML InjectionSYfe265eb5-eaeb-4f47-82dd-238c1d53fec43
1737568lidocaine HCl 20 MG per 2 ML InjectionSYfe265eb5-eaeb-4f47-82dd-238c1d53fec43
1737757lidocaine HCl 40 MG per 2 ML InjectionSYfe265eb5-eaeb-4f47-82dd-238c1d53fec43
1737569Xylocaine-MPF 1 % per 2 ML InjectionSYfe265eb5-eaeb-4f47-82dd-238c1d53fec43
1737762Xylocaine-MPF 100 MG per 5 ML InjectionSYfe265eb5-eaeb-4f47-82dd-238c1d53fec43
1737758Xylocaine-MPF 2 % per 2 ML InjectionSYfe265eb5-eaeb-4f47-82dd-238c1d53fec43
1737762Xylocaine-MPF 2 % per 5 ML InjectionSYfe265eb5-eaeb-4f47-82dd-238c1d53fec43
1737569Xylocaine-MPF 20 MG per 2 ML InjectionSYfe265eb5-eaeb-4f47-82dd-238c1d53fec43
1737758Xylocaine-MPF 40 MG per 2 ML InjectionSYfe265eb5-eaeb-4f47-82dd-238c1d53fec43

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65219-810-01652190810012 mL in 1 VIAL, SINGLE-DOSE2 mlHistorical
65219-810-026521908100225 VIAL, SINGLE-DOSE in 1 TRAY (65219-810-02) / 2 mL in 1 VIAL, SINGLE-DOSE (65219-810-01) 2020-10-300000-00-00NoNoCurrent