FDA.reportPublic FDA data

Lidocaine

Product NDC
53149-4913
11-digit product format
531494913
Labeler code
53149
Product ID
53149-4913_2fae4492-78eb-4c5d-bc33-5eafcc51c875
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine
Dosage form
OINTMENT
Route
TOPICAL
Labeler
All Pharma, LLC
Application
ANDA206297
Marketing category
ANDA
Marketing start
2015-08-10
Marketing end
0000-00-00
Substance
LIDOCAINE
Active strength
50 mg/g
Pharmacologic classes
Amide Local Anesthetic [EPC],Amides [CS],Antiarrhythmic [EPC],Local Anesthesia [PE]
NDC exclude flag
No
Listing certified through
2020-12-31
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
53149-4913-12022-01-28C16284748780-1d6a99b39-363a-a426-e053-dadaa90af4c2Lidocaine Ointment USP, 5% FOR TOPICAL USE DO NOT USE IN THE EYES Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53149-4913-1Lidocaine50 g in 1 JAROINTMENT502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53149-4913LIDOCAINE OINTMENT [ALL PHARMA, LLC]2Legacy NDC, 1 package rows20190830_51c903ae-c92a-4edf-b179-c52c730aec59.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1543069lidocaine 5 % Topical OintmentPSN51c903ae-c92a-4edf-b179-c52c730aec592
1543069lidocaine 0.05 MG/MG Topical OintmentSCD51c903ae-c92a-4edf-b179-c52c730aec592
1543069lidocaine 5 % Topical OintmentSY51c903ae-c92a-4edf-b179-c52c730aec592

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53149-4913-15314949130150 g in 1 JAR (53149-4913-1) 50 g2019-08-290000-00-00NoNoCurrent