FDA.reportPublic FDA data

Xylocaine

Product NDC
63323-496
11-digit product format
633230496
Labeler code
63323
Product ID
63323-496_fa12a8e8-09fd-496f-8cc6-ffe0eb02e2df
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
2011-07-18
Substance
LIDOCAINE HYDROCHLORIDE ANHYDROUS
Active strength
20 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 ANHYDROUS20 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiEC2CNF7XFP
Rxcui1737562, 1737563, 1737566, 1737567, 1737568, 1737569, 1737570, 1737571, 1737636, 1737637, 1737640, 1737641, 1737763, 1737764

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
63323-496-03XylocaineMPF10 mL in 1 AMPULEINJECTION, SOLUTION1013
63323-496-97XylocaineMPF5 in 1 BOXINJECTION, SOLUTION513

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-496-03ML - Milliliter63323-49638c70306-37b7-434b-ac67-20380e88587912020-04-20
63323-496-80ML - Milliliter63323-49608bb1fcf-7fbe-4147-8ffc-8941b7efda1b12012-07-24
63323-496-97ML - Milliliter63323-4967b4bd60d-9078-432c-a36b-755ad502e88512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LIDOCAINE HYDROCHLORIDE ANHYDROUSACTIVE INGREDIENTEC2CNF7XFPXYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]6
LIDOCAINEACTIVE MOIETY98PI200987XYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]6
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBXYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]6
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XXYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]6
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IXYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-496XYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]13Current NDC, Legacy NDC, 2 package rows20240517_d5e0d06f-ba1e-44d4-aa89-39d6c146dc23.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1737570lidocaine HCl 1 % in 10 ML InjectionPSNd5e0d06f-ba1e-44d4-aa89-39d6c146dc2313
1737568lidocaine HCl 1 % in 2 ML InjectionPSNd5e0d06f-ba1e-44d4-aa89-39d6c146dc2313
1737562lidocaine HCl 1 % in 30 ML InjectionPSNd5e0d06f-ba1e-44d4-aa89-39d6c146dc2313
1737566lidocaine HCl 1 % in 5 ML InjectionPSNd5e0d06f-ba1e-44d4-aa89-39d6c146dc2313
1737640lidocaine HCl 1.5 % in 10 ML InjectionPSNd5e0d06f-ba1e-44d4-aa89-39d6c146dc2313
1737636lidocaine HCl 1.5 % in 20 ML InjectionPSNd5e0d06f-ba1e-44d4-aa89-39d6c146dc2313
1737763lidocaine HCl 2 % in 10 ML InjectionPSNd5e0d06f-ba1e-44d4-aa89-39d6c146dc2313
1737571Xylocaine 1 % in 10 ML InjectionPSNd5e0d06f-ba1e-44d4-aa89-39d6c146dc2313
1737569Xylocaine 1 % in 2 ML InjectionPSNd5e0d06f-ba1e-44d4-aa89-39d6c146dc2313
1737563Xylocaine 1 % in 30 ML InjectionPSNd5e0d06f-ba1e-44d4-aa89-39d6c146dc2313
1737567Xylocaine 1 % in 5 ML InjectionPSNd5e0d06f-ba1e-44d4-aa89-39d6c146dc2313
1737641Xylocaine 1.5 % in 10 ML InjectionPSNd5e0d06f-ba1e-44d4-aa89-39d6c146dc2313
1737637Xylocaine 1.5 % in 20 ML InjectionPSNd5e0d06f-ba1e-44d4-aa89-39d6c146dc2313
1737764Xylocaine 2 % in 10 ML InjectionPSNd5e0d06f-ba1e-44d4-aa89-39d6c146dc2313
173757110 ML lidocaine hydrochloride 10 MG/ML Injection [Xylocaine]SBDd5e0d06f-ba1e-44d4-aa89-39d6c146dc2313
173764110 ML lidocaine hydrochloride 15 MG/ML Injection [Xylocaine]SBDd5e0d06f-ba1e-44d4-aa89-39d6c146dc2313
173776410 ML lidocaine hydrochloride 20 MG/ML Injection [Xylocaine]SBDd5e0d06f-ba1e-44d4-aa89-39d6c146dc2313
17375692 ML lidocaine hydrochloride 10 MG/ML Injection [Xylocaine]SBDd5e0d06f-ba1e-44d4-aa89-39d6c146dc2313
173763720 ML lidocaine hydrochloride 15 MG/ML Injection [Xylocaine]SBDd5e0d06f-ba1e-44d4-aa89-39d6c146dc2313
173756330 ML lidocaine hydrochloride 10 MG/ML Injection [Xylocaine]SBDd5e0d06f-ba1e-44d4-aa89-39d6c146dc2313
17375675 ML lidocaine hydrochloride 10 MG/ML Injection [Xylocaine]SBDd5e0d06f-ba1e-44d4-aa89-39d6c146dc2313
173757010 ML lidocaine hydrochloride 10 MG/ML InjectionSCDd5e0d06f-ba1e-44d4-aa89-39d6c146dc2313
173764010 ML lidocaine hydrochloride 15 MG/ML InjectionSCDd5e0d06f-ba1e-44d4-aa89-39d6c146dc2313
173776310 ML lidocaine hydrochloride 20 MG/ML InjectionSCDd5e0d06f-ba1e-44d4-aa89-39d6c146dc2313
17375682 ML lidocaine hydrochloride 10 MG/ML InjectionSCDd5e0d06f-ba1e-44d4-aa89-39d6c146dc2313
173763620 ML lidocaine hydrochloride 15 MG/ML InjectionSCDd5e0d06f-ba1e-44d4-aa89-39d6c146dc2313
173756230 ML lidocaine hydrochloride 10 MG/ML InjectionSCDd5e0d06f-ba1e-44d4-aa89-39d6c146dc2313
17375665 ML lidocaine hydrochloride 10 MG/ML InjectionSCDd5e0d06f-ba1e-44d4-aa89-39d6c146dc2313
173757110 ML Xylocaine 10 MG/ML InjectionSYd5e0d06f-ba1e-44d4-aa89-39d6c146dc2313
173764110 ML Xylocaine 15 MG/ML InjectionSYd5e0d06f-ba1e-44d4-aa89-39d6c146dc2313
173776410 ML Xylocaine 20 MG/ML InjectionSYd5e0d06f-ba1e-44d4-aa89-39d6c146dc2313
17375692 ML Xylocaine 10 MG/ML InjectionSYd5e0d06f-ba1e-44d4-aa89-39d6c146dc2313
173763720 ML Xylocaine 15 MG/ML InjectionSYd5e0d06f-ba1e-44d4-aa89-39d6c146dc2313
173756330 ML Xylocaine 10 MG/ML InjectionSYd5e0d06f-ba1e-44d4-aa89-39d6c146dc2313
17375675 ML Xylocaine 10 MG/ML InjectionSYd5e0d06f-ba1e-44d4-aa89-39d6c146dc2313
1737570lidocaine HCl 1 % in 10 ML InjectionSYd5e0d06f-ba1e-44d4-aa89-39d6c146dc2313
1737568lidocaine HCl 1 % per 2 ML InjectionSYd5e0d06f-ba1e-44d4-aa89-39d6c146dc2313
1737562lidocaine HCl 1 % per 30 ML InjectionSYd5e0d06f-ba1e-44d4-aa89-39d6c146dc2313
1737566lidocaine HCl 1 % per 5 ML InjectionSYd5e0d06f-ba1e-44d4-aa89-39d6c146dc2313
1737640lidocaine HCl 1.5 % per 10 ML InjectionSYd5e0d06f-ba1e-44d4-aa89-39d6c146dc2313
1737636lidocaine HCl 1.5 % per 20 ML InjectionSYd5e0d06f-ba1e-44d4-aa89-39d6c146dc2313
1737570lidocaine HCl 100 MG per 10 ML InjectionSYd5e0d06f-ba1e-44d4-aa89-39d6c146dc2313
1737640lidocaine HCl 150 MG per 10 ML InjectionSYd5e0d06f-ba1e-44d4-aa89-39d6c146dc2313
1737763lidocaine HCl 2 % per 10 ML InjectionSYd5e0d06f-ba1e-44d4-aa89-39d6c146dc2313
1737568lidocaine HCl 20 MG per 2 ML InjectionSYd5e0d06f-ba1e-44d4-aa89-39d6c146dc2313
1737763lidocaine HCl 200 MG per 10 ML InjectionSYd5e0d06f-ba1e-44d4-aa89-39d6c146dc2313
1737636lidocaine HCl 300 MG per 20 ML InjectionSYd5e0d06f-ba1e-44d4-aa89-39d6c146dc2313
1737562lidocaine HCl 300 MG per 30 ML InjectionSYd5e0d06f-ba1e-44d4-aa89-39d6c146dc2313
1737566lidocaine HCl 50 MG per 5 ML InjectionSYd5e0d06f-ba1e-44d4-aa89-39d6c146dc2313
1737571Xylocaine-MPF 1 % per 10 ML InjectionSYd5e0d06f-ba1e-44d4-aa89-39d6c146dc2313
1737569Xylocaine-MPF 1 % per 2 ML InjectionSYd5e0d06f-ba1e-44d4-aa89-39d6c146dc2313
1737563Xylocaine-MPF 1 % per 30 ML InjectionSYd5e0d06f-ba1e-44d4-aa89-39d6c146dc2313
1737567Xylocaine-MPF 1 % per 5 ML InjectionSYd5e0d06f-ba1e-44d4-aa89-39d6c146dc2313
1737641Xylocaine-MPF 1.5 % per 10 ML InjectionSYd5e0d06f-ba1e-44d4-aa89-39d6c146dc2313
1737637Xylocaine-MPF 1.5 % per 20 ML InjectionSYd5e0d06f-ba1e-44d4-aa89-39d6c146dc2313
1737571Xylocaine-MPF 100 MG per 10 ML InjectionSYd5e0d06f-ba1e-44d4-aa89-39d6c146dc2313
1737641Xylocaine-MPF 150 MG per 10 ML InjectionSYd5e0d06f-ba1e-44d4-aa89-39d6c146dc2313
1737764Xylocaine-MPF 2 % per 10 ML InjectionSYd5e0d06f-ba1e-44d4-aa89-39d6c146dc2313
1737569Xylocaine-MPF 20 MG per 2 ML InjectionSYd5e0d06f-ba1e-44d4-aa89-39d6c146dc2313
1737764Xylocaine-MPF 200 MG per 10 ML InjectionSYd5e0d06f-ba1e-44d4-aa89-39d6c146dc2313
1737637Xylocaine-MPF 300 MG per 20 ML InjectionSYd5e0d06f-ba1e-44d4-aa89-39d6c146dc2313
1737563Xylocaine-MPF 300 MG per 30 ML InjectionSYd5e0d06f-ba1e-44d4-aa89-39d6c146dc2313
1737567Xylocaine-MPF 50 MG per 5 ML InjectionSYd5e0d06f-ba1e-44d4-aa89-39d6c146dc2313

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63323-496-036332304960310 mL in 1 AMPULE10 mlHistorical
63323-496-97633230496975 AMPULE in 1 BOX (63323-496-97) / 10 mL in 1 AMPULE (63323-496-03) 5 ampule2011-07-180000-00-00NoNoCurrent