Xylocaine

Product NDC
84549-482
11-digit product format
845490482
Labeler code
84549
Product ID
84549-482_3a3870c9-9b0f-40e4-e063-6294a90a705d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE
Dosage form
INJECTION, SOLUTION
Route
INFILTRATION; PERINEURAL
Labeler
ProPharma Distribution
Application
NDA006488
Marketing category
NDA
Marketing start
2010-08-12
Substance
EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE ANHYDROUS
Active strength
.01; 10 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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
EPINEPHRINE BITARTRATE.01 mg/mL
LIDOCAINE HYDROCHLORIDE ANHYDROUS10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii30Q7KI53AK, EC2CNF7XFP
Rxcui1010751, 1010755

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
0b4ec9ca-d305-43fc-88dd-7a510313efe0Product name120260105
bb209f42-a85f-4fee-9d3d-c9dded168625Product name120251208
49628fc7-2031-4c28-bd31-0ef3aa8f44a3Product name320251118
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
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
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
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
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84549-482-57Xylocaine50 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION502

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1010751lidocaine HCl 1 % / EPINEPHrine 1:100,000 Injectable SolutionPSN386c23fd-1691-98b2-e063-6294a90ab0702
1010755Xylocaine 1 % / EPINEPHrine 1:100,000 Injectable SolutionPSN386c23fd-1691-98b2-e063-6294a90ab0702
1010755epinephrine 0.01 MG/ML / lidocaine hydrochloride 10 MG/ML Injectable Solution [Xylocaine with Epinephrine]SBD386c23fd-1691-98b2-e063-6294a90ab0702
1010751epinephrine 0.01 MG/ML / lidocaine hydrochloride 10 MG/ML Injectable SolutionSCD386c23fd-1691-98b2-e063-6294a90ab0702
1010751epinephrine (as epinephrine bitartrate) 1:100,000 / lidocaine hydrochloride 1 % Injectable SolutionSY386c23fd-1691-98b2-e063-6294a90ab0702
1010751lidocaine HCl 1 % / EPINEPHrine 1:100,000 Injectable SolutionSY386c23fd-1691-98b2-e063-6294a90ab0702
1010755Xylocaine 1 % with epinephrine 1:100,000 Injectable SolutionSY386c23fd-1691-98b2-e063-6294a90ab0702
1010755Xylocaine with Epinephrine 1/1:100,000 (lidocaine hydrochloride / epinephrine (as epinephrine bitartrate) ) Injectable SolutionSY386c23fd-1691-98b2-e063-6294a90ab0702

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84549-482-578454904825750 mL in 1 VIAL, MULTI-DOSE (84549-482-57) 50 ml2025-08-27NoNoCurrent