Lidocaine

Product NDC
52565-008
11-digit product format
525650008
Labeler code
52565
Product ID
52565-008_528ee36a-310d-473c-b560-f1abe3d6c865
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lidocaine
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Teligent Pharma, Inc.
Application
ANDA205318
Marketing category
ANDA
Marketing start
2017-02-27
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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
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
52565-008-142023-01-30C16284748780-1f386c64a-1b99-0266-e053-dadaa90a7c1aLIDOCAINE OINTMENT USP, 5%
52565-008-552023-01-30C16284748780-1f386c64a-1b99-0266-e053-dadaa90a7c1aLIDOCAINE OINTMENT USP, 5%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52565-008-14Lidocaine1 in 1 CARTONOINTMENT16
52565-008-14Lidocaine35.44 g in 1 TUBEOINTMENT35.446
52565-008-55Lidocaine50 g in 1 JAROINTMENT506
52565-008-55Lidocaine1 in 1 CARTONOINTMENT16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52565-008-14GM - Gram52565-008cee9d3df-bb17-401e-adfb-1a30da69189112016-04-04
52565-008-55GM - Gram52565-008d1aff958-0052-4ed8-9e28-b35a2e4603dd12017-10-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52565-008LIDOCAINE (LIDOCAINE) OINTMENT [TELIGENT PHARMA, INC.]6Legacy NDC, 4 package rows20181121_12639881-632d-445d-9ff5-b84567f49179.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1543069lidocaine 5 % Topical OintmentPSN12639881-632d-445d-9ff5-b84567f491796
1543069lidocaine 0.05 MG/MG Topical OintmentSCD12639881-632d-445d-9ff5-b84567f491796
1543069lidocaine 5 % Topical OintmentSY12639881-632d-445d-9ff5-b84567f491796
1543069lidocaine 5 % Topical OintmentPSN857bf526-ab2a-b173-e053-2991aa0a04cf3
1543069lidocaine 0.05 MG/MG Topical OintmentSCD857bf526-ab2a-b173-e053-2991aa0a04cf3
1543069lidocaine 5 % Topical OintmentSY857bf526-ab2a-b173-e053-2991aa0a04cf3
1543069lidocaine 5 % Topical OintmentPSNa8cbe325-5ed1-a2aa-e053-2a95a90abb3c2
1543069lidocaine 5 % Topical OintmentPSNcbf01b82-c43f-4bed-a1df-7569f4816c762
1543069lidocaine 0.05 MG/MG Topical OintmentSCDa8cbe325-5ed1-a2aa-e053-2a95a90abb3c2
1543069lidocaine 0.05 MG/MG Topical OintmentSCDcbf01b82-c43f-4bed-a1df-7569f4816c762
1543069lidocaine 5 % Topical OintmentSYa8cbe325-5ed1-a2aa-e053-2a95a90abb3c2
1543069lidocaine 5 % Topical OintmentSYcbf01b82-c43f-4bed-a1df-7569f4816c762
1543069lidocaine 5 % Topical OintmentPSN2d97e75c-7dfd-417e-b8f3-31e8b5dd90fe1
1543069lidocaine 5 % Topical OintmentPSNbc028dba-b823-0eeb-e053-2a95a90a79051
1543069lidocaine 5 % Topical OintmentPSNc18f0c2b-cd05-4458-888f-47b4a11069371
1600976menthol 10 % Topical SolutionPSN2d97e75c-7dfd-417e-b8f3-31e8b5dd90fe1
1543069lidocaine 0.05 MG/MG Topical OintmentSCD2d97e75c-7dfd-417e-b8f3-31e8b5dd90fe1
1543069lidocaine 0.05 MG/MG Topical OintmentSCDbc028dba-b823-0eeb-e053-2a95a90a79051
1543069lidocaine 0.05 MG/MG Topical OintmentSCDc18f0c2b-cd05-4458-888f-47b4a11069371
1600976menthol 100 MG/ML Topical SolutionSCD2d97e75c-7dfd-417e-b8f3-31e8b5dd90fe1
1543069lidocaine 5 % Topical OintmentSY2d97e75c-7dfd-417e-b8f3-31e8b5dd90fe1
1543069lidocaine 5 % Topical OintmentSYbc028dba-b823-0eeb-e053-2a95a90a79051
1543069lidocaine 5 % Topical OintmentSYc18f0c2b-cd05-4458-888f-47b4a11069371
1600976menthol 10 % Topical SolutionSY2d97e75c-7dfd-417e-b8f3-31e8b5dd90fe1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52565-008-14525650008141 TUBE in 1 CARTON (52565-008-14) > 35.44 g in 1 TUBE1 tube2017-02-270000-00-00NoNoCurrent
52565-008-55525650008551 JAR in 1 CARTON (52565-008-55) > 50 g in 1 JAR1 jar2017-07-170000-00-00NoNoCurrent