Xylocaine

Product NDC
76420-369
11-digit product format
764200369
Labeler code
76420
Product ID
76420-369_366ad8d7-33a0-b252-e063-6294a90a7a16
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LIDOCAINE HYDROCHLORIDE
Dosage form
INJECTION, SOLUTION
Route
INFILTRATION; PERINEURAL
Labeler
Asclemed USA, Inc.
Application
NDA006488
Marketing category
NDA
Marketing start
2010-08-12
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE HYDROCHLORIDE ANHYDROUS20 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiEC2CNF7XFP
Rxcui1010671, 1010673

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
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
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
76420-369-10Xylocaine10 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION101
76420-369-25Xylocaine25 in 1 TRAYINJECTION, SOLUTION251

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1010671lidocaine HCl 2 % Injectable SolutionPSN25370b0f-0ac6-4a03-abe6-d73d651921801
1010673Xylocaine 2 % Injectable SolutionPSN25370b0f-0ac6-4a03-abe6-d73d651921801
1010673lidocaine hydrochloride 20 MG/ML Injectable Solution [Xylocaine]SBD25370b0f-0ac6-4a03-abe6-d73d651921801
1010671lidocaine hydrochloride 20 MG/ML Injectable SolutionSCD25370b0f-0ac6-4a03-abe6-d73d651921801
1010671lidocaine hydrochloride 2 % Injectable SolutionSY25370b0f-0ac6-4a03-abe6-d73d651921801
1010673Xylocaine 2 % Injectable SolutionSY25370b0f-0ac6-4a03-abe6-d73d651921801
1010673Xylocaine 20 MG/ML Injectable SolutionSY25370b0f-0ac6-4a03-abe6-d73d651921801

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76420-369-107642003691010 mL in 1 VIAL, MULTI-DOSE10 mlHistorical
76420-369-257642003692525 VIAL, MULTI-DOSE in 1 TRAY (76420-369-25) / 10 mL in 1 VIAL, MULTI-DOSE (76420-369-10) 2025-05-31NoNoHistorical