Lidocaine

Product NDC
50383-341
11-digit product format
503830341
Labeler code
50383
Product ID
50383-341_416985c1-71b8-4a5f-8d7b-a14934aa1946
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lidocaine
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Akorn
Application
ANDA205318
Marketing category
ANDA
Marketing start
2016-02-01
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
2023-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50383-341-352023-07-28C16284748780-10191ceaa-6875-198a-e063-dbdaa90aec3eLIDOCAINE OINTMENT USP, 5%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50383-341-35Lidocaine35.44 g in 1 TUBEOINTMENT35.443
50383-341-35Lidocaine1 in 1 CARTONOINTMENT13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50383-341-35GM - Gram50383-3413aa9d236-a282-461b-947e-6f0bcfde0dcb12021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50383-341LIDOCAINE OINTMENT [AKORN]3Legacy NDC, 2 package rows20221116_f9303361-534d-4daa-bb4f-29992a0232dc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1543069lidocaine 5 % Topical OintmentPSNf9303361-534d-4daa-bb4f-29992a0232dc3
1543069lidocaine 0.05 MG/MG Topical OintmentSCDf9303361-534d-4daa-bb4f-29992a0232dc3
1543069lidocaine 5 % Topical OintmentSYf9303361-534d-4daa-bb4f-29992a0232dc3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50383-341-35503830341351 TUBE in 1 CARTON (50383-341-35) > 35.44 g in 1 TUBE1 tube2020-03-100000-00-00NoNoCurrent