FDA.reportPublic FDA data

XYLOCAINE

Product NDC
21695-466
11-digit product format
216950466
Labeler code
21695
Product ID
21695-466_57964c72-5ffe-4548-bca0-a5b0ca57ecb1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine Hydrochloride
Dosage form
INJECTION
Route
INFILTRATION
Labeler
Rebel Distributors Corp
Application
NDA006488
Marketing category
NDA
Marketing start
1948-11-19
Marketing end
0000-00-00
Substance
LIDOCAINE HYDROCHLORIDE
Active strength
10 mg/mL
Pharmacologic classes
Amide Local Anesthetic [EPC],Amides [CS],Antiarrhythmic [EPC],Local Anesthesia [PE]
NDC exclude flag
E
Listing certified through
2017-12-31
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
21695-466-202019-09-24C16284748780-1934fe258-475e-48b1-e053-8cdaa90a720aXylocaine® (lidocaine HCl Injection, USP) Xylocaine® (lidocaine HCl and epinephrine Injection, USP) For Infiltration and Nerve Block

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-466-20XYLOCAINE20 mL in 1 VIAL, MULTI-DOSEINJECTION201

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Lidocaine HydrochlorideACTIVE INGREDIENTV13007Z41AXYLOCAINE (LIDOCAINE HYDROCHLORIDE) INJECTION [REBEL DISTRIBUTORS CORP]1
LidocaineACTIVE MOIETY98PI200987XYLOCAINE (LIDOCAINE HYDROCHLORIDE) INJECTION [REBEL DISTRIBUTORS CORP]1
hydrochloric acidINACTIVE INGREDIENTQTT17582CBXYLOCAINE (LIDOCAINE HYDROCHLORIDE) INJECTION [REBEL DISTRIBUTORS CORP]1
sodium chlorideINACTIVE INGREDIENT451W47IQ8XXYLOCAINE (LIDOCAINE HYDROCHLORIDE) INJECTION [REBEL DISTRIBUTORS CORP]1
sodium hydroxideINACTIVE INGREDIENT55X04QC32IXYLOCAINE (LIDOCAINE HYDROCHLORIDE) INJECTION [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-466XYLOCAINE (LIDOCAINE HYDROCHLORIDE) INJECTION [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20110414_57964c72-5ffe-4548-bca0-a5b0ca57ecb1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1010033lidocaine HCl 1 % Injectable SolutionPSN57964c72-5ffe-4548-bca0-a5b0ca57ecb11
1010035Xylocaine 1 % Injectable SolutionPSN57964c72-5ffe-4548-bca0-a5b0ca57ecb11
1010035lidocaine hydrochloride 10 MG/ML Injectable Solution [Xylocaine]SBD57964c72-5ffe-4548-bca0-a5b0ca57ecb11
1010033lidocaine hydrochloride 10 MG/ML Injectable SolutionSCD57964c72-5ffe-4548-bca0-a5b0ca57ecb11
1010033lidocaine hydrochloride 1 % Injectable SolutionSY57964c72-5ffe-4548-bca0-a5b0ca57ecb11
1010035Xylocaine 1 % Injectable SolutionSY57964c72-5ffe-4548-bca0-a5b0ca57ecb11
1010035Xylocaine 10 MG/ML Injectable SolutionSY57964c72-5ffe-4548-bca0-a5b0ca57ecb11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
21695-466-202169504662020 mL in 1 VIAL, MULTI-DOSE20 mlHistorical