FDA.reportPublic FDA data

Xylocaine

Product NDC
63323-488
11-digit product format
633230488
Labeler code
63323
Product ID
63323-488_ea480a68-5927-4278-9deb-2956961da428
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE
Dosage form
INJECTION, SOLUTION
Route
EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL
Labeler
Fresenius Kabi USA, LLC
Application
NDA006488
Marketing category
NDA
Marketing start
2010-08-12
Substance
EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE ANHYDROUS
Active strength
.005; 15 mg/mL; mg/mL
Pharmacologic 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]
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
EPINEPHRINE BITARTRATE.005 mg/mL
LIDOCAINE HYDROCHLORIDE ANHYDROUS15 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii30Q7KI53AK, EC2CNF7XFP
Rxcui1010033, 1010035, 1010671, 1010673, 1010688, 1010692, 1010745, 1010749, 1010751, 1010755, 1010759, 1010763, 1010900, 1010902, 1737343, 1737345, 1737562, 1737563, 1737566, 1737567

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0b4ec9ca-d305-43fc-88dd-7a510313efe0Product name120260105
bb209f42-a85f-4fee-9d3d-c9dded168625Product name120251208
49628fc7-2031-4c28-bd31-0ef3aa8f44a3Product name320251118
cbf85893-59ef-423f-87d4-a573c000a8b9Product name820250731
b5b1095b-40cd-8a9e-b111-502545045b07Product name420250325
e190029e-423b-473c-8e04-2ada59b5b711Product name120250314
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
e0031c74-3853-42bc-8e10-86dbbe83992eProduct name220231116
f7046b89-2016-499a-adc6-78479172abc6Product name120230425
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
2686d634-e712-4007-8dbf-3d37c6c4d71fProduct name120181121
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
bd49bb86-2d32-4a7a-a594-eeda2e29af42Product name120180118
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
3becbe78-12d9-4ad2-9b4c-1e36f8d1303aProduct name120170815
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63323-488-01XylocaineMPF10 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION1013
63323-488-03XylocaineMPF30 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION3013
63323-488-07XylocaineMPF30 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION3013
63323-488-17XylocaineMPF25 in 1 TRAYINJECTION, SOLUTION2513
63323-488-31XylocaineMPF5 in 1 CARTONINJECTION, SOLUTION513
63323-488-37XylocaineMPF25 in 1 TRAYINJECTION, SOLUTION2513

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-488-07ML - Milliliter63323-4883ae53bc4-ca37-4a40-ae51-697ff7f942a312021-05-05
63323-488-17ML - Milliliter63323-48818b9fc6a-2197-402d-ba0b-67a7dd50f4a012012-07-24
63323-488-31ML - Milliliter63323-4884c06246a-44de-4b6a-960f-f9e1d7a1095612012-07-24
63323-488-37ML - Milliliter63323-488b5b7fef8-47c2-4529-a097-63972a6a38bc12012-07-24
63323-488-92ML - Milliliter63323-488b0dc8021-2eb0-4ef4-b7b9-6abd2da2a41d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
EPINEPHRINE BITARTRATEACTIVE INGREDIENT30Q7KI53AKXYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]6
LIDOCAINE HYDROCHLORIDE ANHYDROUSACTIVE INGREDIENTEC2CNF7XFPXYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]6
EPINEPHRINEACTIVE MOIETYYKH834O4BHXYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]6
LIDOCAINEACTIVE MOIETY98PI200987XYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]6
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPXYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]6
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBXYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]6
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TXYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]6
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XXYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]6
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IXYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]6
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3CXYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-488XYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]13Current NDC, Legacy NDC, 6 package rows20210831_ba082c2f-64f4-419d-9c88-74f203316e17.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1010745lidocaine HCl 0.5 % / EPINEPHrine 1:200,000 Injectable SolutionPSNba082c2f-64f4-419d-9c88-74f203316e1713
1737343lidocaine HCl 0.5 % in 50 ML InjectionPSNba082c2f-64f4-419d-9c88-74f203316e1713
1010900lidocaine HCl 0.5 % Injectable SolutionPSNba082c2f-64f4-419d-9c88-74f203316e1713
1010751lidocaine HCl 1 % / EPINEPHrine 1:100,000 Injectable SolutionPSNba082c2f-64f4-419d-9c88-74f203316e1713
1867938lidocaine HCl 1 % / EPINEPHrine 1:200,000 in 10 ML InjectionPSNba082c2f-64f4-419d-9c88-74f203316e1713
1867943lidocaine HCl 1 % / EPINEPHrine 1:200,000 in 30 ML InjectionPSNba082c2f-64f4-419d-9c88-74f203316e1713
1737570lidocaine HCl 1 % in 10 ML InjectionPSNba082c2f-64f4-419d-9c88-74f203316e1713
1737568lidocaine HCl 1 % in 2 ML InjectionPSNba082c2f-64f4-419d-9c88-74f203316e1713
1737562lidocaine HCl 1 % in 30 ML InjectionPSNba082c2f-64f4-419d-9c88-74f203316e1713
1737566lidocaine HCl 1 % in 5 ML InjectionPSNba082c2f-64f4-419d-9c88-74f203316e1713
1010033lidocaine HCl 1 % Injectable SolutionPSNba082c2f-64f4-419d-9c88-74f203316e1713
1867992lidocaine HCl 1.5 % / EPINEPHrine 1:200,000 in 10 ML InjectionPSNba082c2f-64f4-419d-9c88-74f203316e1713
1867996lidocaine HCl 1.5 % / EPINEPHrine 1:200,000 in 30 ML InjectionPSNba082c2f-64f4-419d-9c88-74f203316e1713
1010759lidocaine HCl 2 % / EPINEPHrine 1:100,000 Injectable SolutionPSNba082c2f-64f4-419d-9c88-74f203316e1713
1868028lidocaine HCl 2 % / EPINEPHrine 1:200,000 in 10 ML InjectionPSNba082c2f-64f4-419d-9c88-74f203316e1713
1010688lidocaine HCl 2 % / EPINEPHrine 1:200,000 in 20 ML InjectionPSNba082c2f-64f4-419d-9c88-74f203316e1713
1737757lidocaine HCl 2 % in 2 ML InjectionPSNba082c2f-64f4-419d-9c88-74f203316e1713
1737761lidocaine HCl 2 % in 5 ML InjectionPSNba082c2f-64f4-419d-9c88-74f203316e1713
1010671lidocaine HCl 2 % Injectable SolutionPSNba082c2f-64f4-419d-9c88-74f203316e1713
1010749Xylocaine 0.5 % / EPINEPHrine 1:200,000 Injectable SolutionPSNba082c2f-64f4-419d-9c88-74f203316e1713
1737345Xylocaine 0.5 % in 50 ML InjectionPSNba082c2f-64f4-419d-9c88-74f203316e1713
1010902Xylocaine 0.5 % Injectable SolutionPSNba082c2f-64f4-419d-9c88-74f203316e1713
1010755Xylocaine 1 % / EPINEPHrine 1:100,000 Injectable SolutionPSNba082c2f-64f4-419d-9c88-74f203316e1713
1867940Xylocaine 1 % / EPINEPHrine 1:200,000 in 10 ML InjectionPSNba082c2f-64f4-419d-9c88-74f203316e1713
1867944Xylocaine 1 % / EPINEPHrine 1:200,000 in 30 ML InjectionPSNba082c2f-64f4-419d-9c88-74f203316e1713
1737571Xylocaine 1 % in 10 ML InjectionPSNba082c2f-64f4-419d-9c88-74f203316e1713
1737569Xylocaine 1 % in 2 ML InjectionPSNba082c2f-64f4-419d-9c88-74f203316e1713
1737563Xylocaine 1 % in 30 ML InjectionPSNba082c2f-64f4-419d-9c88-74f203316e1713
1737567Xylocaine 1 % in 5 ML InjectionPSNba082c2f-64f4-419d-9c88-74f203316e1713
1010035Xylocaine 1 % Injectable SolutionPSNba082c2f-64f4-419d-9c88-74f203316e1713
1867993Xylocaine 1.5 % / EPINEPHrine 1:200,000 in 10 ML InjectionPSNba082c2f-64f4-419d-9c88-74f203316e1713
1867997Xylocaine 1.5 % / EPINEPHrine 1:200,000 in 30 ML InjectionPSNba082c2f-64f4-419d-9c88-74f203316e1713
1010763Xylocaine 2 % / EPINEPHrine 1:100,000 Injectable SolutionPSNba082c2f-64f4-419d-9c88-74f203316e1713
1868029Xylocaine 2 % / EPINEPHrine 1:200,000 in 10 ML InjectionPSNba082c2f-64f4-419d-9c88-74f203316e1713
1010692Xylocaine 2 % / EPINEPHrine 1:200,000 in 20 ML InjectionPSNba082c2f-64f4-419d-9c88-74f203316e1713
1737758Xylocaine 2 % in 2 ML InjectionPSNba082c2f-64f4-419d-9c88-74f203316e1713
1737762Xylocaine 2 % in 5 ML InjectionPSNba082c2f-64f4-419d-9c88-74f203316e1713
1010673Xylocaine 2 % Injectable SolutionPSNba082c2f-64f4-419d-9c88-74f203316e1713
186794010 ML epinephrine 0.005 MG/ML / lidocaine hydrochloride 10 MG/ML Injection [Xylocaine with Epinephrine]SBDba082c2f-64f4-419d-9c88-74f203316e1713
186799310 ML epinephrine 0.005 MG/ML / lidocaine hydrochloride 15 MG/ML Injection [Xylocaine with Epinephrine]SBDba082c2f-64f4-419d-9c88-74f203316e1713
186802910 ML epinephrine 0.005 MG/ML / lidocaine hydrochloride 20 MG/ML Injection [Xylocaine with Epinephrine]SBDba082c2f-64f4-419d-9c88-74f203316e1713
173757110 ML lidocaine hydrochloride 10 MG/ML Injection [Xylocaine]SBDba082c2f-64f4-419d-9c88-74f203316e1713
17375692 ML lidocaine hydrochloride 10 MG/ML Injection [Xylocaine]SBDba082c2f-64f4-419d-9c88-74f203316e1713
17377582 ML lidocaine hydrochloride 20 MG/ML Injection [Xylocaine]SBDba082c2f-64f4-419d-9c88-74f203316e1713
101069220 ML epinephrine 0.005 MG/ML / lidocaine hydrochloride 20 MG/ML Injection [Xylocaine with Epinephrine]SBDba082c2f-64f4-419d-9c88-74f203316e1713
186794430 ML epinephrine 0.005 MG/ML / lidocaine hydrochloride 10 MG/ML Injection [Xylocaine with Epinephrine]SBDba082c2f-64f4-419d-9c88-74f203316e1713
186799730 ML epinephrine 0.005 MG/ML / lidocaine hydrochloride 15 MG/ML Injection [Xylocaine with Epinephrine]SBDba082c2f-64f4-419d-9c88-74f203316e1713
173756330 ML lidocaine hydrochloride 10 MG/ML Injection [Xylocaine]SBDba082c2f-64f4-419d-9c88-74f203316e1713
17375675 ML lidocaine hydrochloride 10 MG/ML Injection [Xylocaine]SBDba082c2f-64f4-419d-9c88-74f203316e1713
17377625 ML lidocaine hydrochloride 20 MG/ML Injection [Xylocaine]SBDba082c2f-64f4-419d-9c88-74f203316e1713
173734550 ML lidocaine hydrochloride 5 MG/ML Injection [Xylocaine]SBDba082c2f-64f4-419d-9c88-74f203316e1713
1010749epinephrine 0.005 MG/ML / lidocaine hydrochloride 5 MG/ML Injectable Solution [Xylocaine with Epinephrine]SBDba082c2f-64f4-419d-9c88-74f203316e1713
1010755epinephrine 0.01 MG/ML / lidocaine hydrochloride 10 MG/ML Injectable Solution [Xylocaine with Epinephrine]SBDba082c2f-64f4-419d-9c88-74f203316e1713
1010763epinephrine 0.01 MG/ML / lidocaine hydrochloride 20 MG/ML Injectable Solution [Xylocaine with Epinephrine]SBDba082c2f-64f4-419d-9c88-74f203316e1713
1010035lidocaine hydrochloride 10 MG/ML Injectable Solution [Xylocaine]SBDba082c2f-64f4-419d-9c88-74f203316e1713
1010673lidocaine hydrochloride 20 MG/ML Injectable Solution [Xylocaine]SBDba082c2f-64f4-419d-9c88-74f203316e1713
1010902lidocaine hydrochloride 5 MG/ML Injectable Solution [Xylocaine]SBDba082c2f-64f4-419d-9c88-74f203316e1713
186793810 ML epinephrine 0.005 MG/ML / lidocaine hydrochloride 10 MG/ML InjectionSCDba082c2f-64f4-419d-9c88-74f203316e1713
186799210 ML epinephrine 0.005 MG/ML / lidocaine hydrochloride 15 MG/ML InjectionSCDba082c2f-64f4-419d-9c88-74f203316e1713
186802810 ML epinephrine 0.005 MG/ML / lidocaine hydrochloride 20 MG/ML InjectionSCDba082c2f-64f4-419d-9c88-74f203316e1713
173757010 ML lidocaine hydrochloride 10 MG/ML InjectionSCDba082c2f-64f4-419d-9c88-74f203316e1713
17375682 ML lidocaine hydrochloride 10 MG/ML InjectionSCDba082c2f-64f4-419d-9c88-74f203316e1713
17377572 ML lidocaine hydrochloride 20 MG/ML InjectionSCDba082c2f-64f4-419d-9c88-74f203316e1713
101068820 ML epinephrine 0.005 MG/ML / lidocaine hydrochloride 20 MG/ML InjectionSCDba082c2f-64f4-419d-9c88-74f203316e1713
186794330 ML epinephrine 0.005 MG/ML / lidocaine hydrochloride 10 MG/ML InjectionSCDba082c2f-64f4-419d-9c88-74f203316e1713
186799630 ML epinephrine 0.005 MG/ML / lidocaine hydrochloride 15 MG/ML InjectionSCDba082c2f-64f4-419d-9c88-74f203316e1713
173756230 ML lidocaine hydrochloride 10 MG/ML InjectionSCDba082c2f-64f4-419d-9c88-74f203316e1713
17375665 ML lidocaine hydrochloride 10 MG/ML InjectionSCDba082c2f-64f4-419d-9c88-74f203316e1713
17377615 ML lidocaine hydrochloride 20 MG/ML InjectionSCDba082c2f-64f4-419d-9c88-74f203316e1713
173734350 ML lidocaine hydrochloride 5 MG/ML InjectionSCDba082c2f-64f4-419d-9c88-74f203316e1713
1010745epinephrine 0.005 MG/ML / lidocaine hydrochloride 5 MG/ML Injectable SolutionSCDba082c2f-64f4-419d-9c88-74f203316e1713
1010751epinephrine 0.01 MG/ML / lidocaine hydrochloride 10 MG/ML Injectable SolutionSCDba082c2f-64f4-419d-9c88-74f203316e1713
1010759epinephrine 0.01 MG/ML / lidocaine hydrochloride 20 MG/ML Injectable SolutionSCDba082c2f-64f4-419d-9c88-74f203316e1713
1010033lidocaine hydrochloride 10 MG/ML Injectable SolutionSCDba082c2f-64f4-419d-9c88-74f203316e1713
1010671lidocaine hydrochloride 20 MG/ML Injectable SolutionSCDba082c2f-64f4-419d-9c88-74f203316e1713
1010900lidocaine hydrochloride 5 MG/ML Injectable SolutionSCDba082c2f-64f4-419d-9c88-74f203316e1713
173757110 ML Xylocaine 10 MG/ML InjectionSYba082c2f-64f4-419d-9c88-74f203316e1713
17375692 ML Xylocaine 10 MG/ML InjectionSYba082c2f-64f4-419d-9c88-74f203316e1713
17377582 ML Xylocaine 20 MG/ML InjectionSYba082c2f-64f4-419d-9c88-74f203316e1713
173756330 ML Xylocaine 10 MG/ML InjectionSYba082c2f-64f4-419d-9c88-74f203316e1713

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63323-488-016332304880110 mL in 1 VIAL, SINGLE-DOSE10 mlHistorical
63323-488-036332304880330 mL in 1 VIAL, SINGLE-DOSE30 mlHistorical
63323-488-076332304880730 mL in 1 VIAL, SINGLE-DOSE30 mlHistorical
63323-488-176332304881725 VIAL, SINGLE-DOSE in 1 TRAY (63323-488-17) / 10 mL in 1 VIAL, SINGLE-DOSE (63323-488-01) 2010-08-120000-00-00NoNoCurrent
63323-488-31633230488315 VIAL, SINGLE-DOSE in 1 CARTON (63323-488-31) / 30 mL in 1 VIAL, SINGLE-DOSE (63323-488-03) 2010-08-120000-00-00NoNoCurrent
63323-488-376332304883725 VIAL, SINGLE-DOSE in 1 TRAY (63323-488-37) / 30 mL in 1 VIAL, SINGLE-DOSE (63323-488-07) 2010-08-120000-00-00NoNoCurrent