FDA.reportPublic FDA data

Lidocaine

Product NDC
50436-0933
11-digit product format
504360933
Labeler code
50436
Product ID
50436-0933_7867908c-c0e2-4d1b-b178-0be2a3014a40
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Unit Dose Services
Application
ANDA040911
Marketing category
ANDA
Marketing start
2012-03-12
Marketing end
0000-00-00
Substance
LIDOCAINE
Active strength
5 g/100g
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
50436-0933-12021-01-29C16284748780-1ba0f9c33-40bc-a910-e053-dadaa90a0b85LIDOCAINE OINTMENT USP, 5%
50436-0933-22021-01-29C16284748780-1ba0f9c33-40bc-a910-e053-dadaa90a0b85LIDOCAINE OINTMENT USP, 5%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-0933-1Lidocaine1 in 1 CARTONOINTMENT14
50436-0933-1Lidocaine35.44 g in 1 TUBEOINTMENT35.444
50436-0933-2Lidocaine50 g in 1 JAROINTMENT504

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50436-0933-1GM - Gram50436-093347e68f5c-6f34-4d07-bb0e-12203c6fa92412016-12-07
50436-0933-2GM - Gram50436-09338a49e062-6bf3-48b2-b88e-5b2412f39e4212016-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-0933LIDOCAINE OINTMENT [UNIT DOSE SERVICES]4Legacy NDC, 3 package rows20170228_03bd61bf-85a7-4963-8f06-57fd6d48a4e8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1543069lidocaine 5 % Topical OintmentPSN03bd61bf-85a7-4963-8f06-57fd6d48a4e84
1543069lidocaine 0.05 MG/MG Topical OintmentSCD03bd61bf-85a7-4963-8f06-57fd6d48a4e84
1543069lidocaine 5 % Topical OintmentSY03bd61bf-85a7-4963-8f06-57fd6d48a4e84

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
50436-0933-1504360933011 in 1 CARTONHistorical
50436-0933-25043609330250 g in 1 JAR50 gHistorical