FDA.reportPublic FDA data

lidocaine

Product NDC
53149-4910
11-digit product format
531494910
Labeler code
53149
Product ID
53149-4910_56aa752a-a904-42a2-bf80-ad956dfed7dd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lidocaine
Dosage form
OINTMENT
Route
TOPICAL
Labeler
All Pharma, LLC
Application
ANDA206498
Marketing category
ANDA
Marketing start
2016-07-01
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
2021-12-31
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
53149-4910-12022-01-28C16284748780-19d75b9d0-e809-f424-e053-dadaa90a57ceLidocaine Ointment, 5% for topical use DO NOT USE IN THE EYES Rx Only
53149-4910-12020-10-16C16284748780-19d75b9d0-e809-f424-e053-dadaa90a57ceLidocaine Ointment, 5% for topical use DO NOT USE IN THE EYES Rx Only
53149-4910-12020-01-31C16284748780-19d75b9d0-e809-f424-e053-dadaa90a57ceLidocaine Ointment, 5% for topical use DO NOT USE IN THE EYES Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53149-4910-1lidocaine1 in 1 CARTONOINTMENT17
53149-4910-1lidocaine35.44 g in 1 TUBEOINTMENT35.447

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53149-4910-1GM - Gram53149-49109f421d6b-9536-418f-b507-76b1cac1a74e12018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53149-4910LIDOCAINE OINTMENT [ALL PHARMA, LLC]7Legacy NDC, 2 package rows20201017_4704b33c-19bf-47d0-abf7-e1fbaa1518a5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1543069lidocaine 5 % Topical OintmentPSN4704b33c-19bf-47d0-abf7-e1fbaa1518a57
1543069lidocaine 0.05 MG/MG Topical OintmentSCD4704b33c-19bf-47d0-abf7-e1fbaa1518a57
1543069lidocaine 5 % Topical OintmentSY4704b33c-19bf-47d0-abf7-e1fbaa1518a57

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53149-4910-1531494910011 TUBE in 1 CARTON (53149-4910-1) > 35.44 g in 1 TUBE1 tube2018-09-060000-00-00NoNoCurrent