Xylocaine

Product NDC
52584-485
11-digit product format
525840485
Labeler code
52584
Product ID
52584-485_65258d73-c6f1-472f-be9a-2df8789e9e93
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INFILTRATION; PERINEURAL
Labeler
General Injectables and Vaccines, inc.
Application
NDA006488
Marketing category
NDA
Marketing start
2011-09-26
Marketing end
2026-02-28
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
0000-00-00
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52584-485-272019-10-29C16284748780-1960f7f55-c848-8e05-e053-dbdaa90a074aXylocaine 1% (10mg/mL)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52584-485-27Xylocaine1 in 1 BAGINJECTION, SOLUTION11
52584-485-27Xylocaine20 mL in 1 VIALINJECTION, SOLUTION201

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52584-485XYLOCAINE (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION [GENERAL INJECTABLES AND VACCINES, INC.]8Legacy NDC20221223_149b6307-91f4-4e0d-8741-0a7211e1aaff.zip
52584-485XYLOCAINE (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC]1Legacy NDC, 2 package rows20110928_1a28f8fe-7334-452a-b8f7-99c9c1eca953.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1010033lidocaine HCl 1 % Injectable SolutionPSN1a28f8fe-7334-452a-b8f7-99c9c1eca9531
1010035Xylocaine 1 % Injectable SolutionPSN1a28f8fe-7334-452a-b8f7-99c9c1eca9531
1010035lidocaine hydrochloride 10 MG/ML Injectable Solution [Xylocaine]SBD1a28f8fe-7334-452a-b8f7-99c9c1eca9531
1010033lidocaine hydrochloride 10 MG/ML Injectable SolutionSCD1a28f8fe-7334-452a-b8f7-99c9c1eca9531
1010033lidocaine hydrochloride 1 % Injectable SolutionSY1a28f8fe-7334-452a-b8f7-99c9c1eca9531
1010035Xylocaine 1 % Injectable SolutionSY1a28f8fe-7334-452a-b8f7-99c9c1eca9531
1010035Xylocaine 10 MG/ML Injectable SolutionSY1a28f8fe-7334-452a-b8f7-99c9c1eca9531

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52584-485-27525840485271 VIAL in 1 BAG (52584-485-27) > 20 mL in 1 VIAL1 vial2018-11-050000-00-00NoNoCurrent
52584-485-57525840485571 VIAL in 1 BAG (52584-485-57) > 50 mL in 1 VIAL1 vial2011-10-250000-00-00NoNoCurrent