Lidocaine

Product NDC
57539-0221
11-digit product format
575390221
Labeler code
57539
Product ID
57539-0221_460ea4ed-64ab-4fe2-aac2-6dca496a204d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Novocol Inc.
Application
ANDA040911
Marketing category
ANDA
Marketing start
2011-10-01
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
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57539-0221-12019-11-13C16284748780-197449f38-c122-f6ea-e053-dbdaa90aa703LIDOCAINE OINTMENT USP, 5%
57539-0221-52019-11-13C16284748780-197449f38-c122-f6ea-e053-dbdaa90aa703LIDOCAINE OINTMENT USP, 5%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57539-0221-1Lidocaine50 g in 1 JAROINTMENT501
57539-0221-5Lidocaine35.44 g in 1 TUBEOINTMENT35.441
57539-0221-5Lidocaine1 in 1 CARTONOINTMENT11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LidocaineACTIVE INGREDIENT98PI200987LIDOCAINE OINTMENT [NOVOCOL INC.]1
LidocaineACTIVE MOIETY98PI200987LIDOCAINE OINTMENT [NOVOCOL INC.]1
Polyethylene Glycol 1450INACTIVE INGREDIENTOJ4Z5Z32L4LIDOCAINE OINTMENT [NOVOCOL INC.]1
Polyethylene Glycol 300INACTIVE INGREDIENT5655G9Y8AQLIDOCAINE OINTMENT [NOVOCOL INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57539-0221LIDOCAINE OINTMENT [NOVOCOL INC.]1Legacy NDC, 3 package rows20120328_c66b3509-c670-4124-86ac-da313958aabd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1543069lidocaine 5 % Topical OintmentPSNc66b3509-c670-4124-86ac-da313958aabd1
1543069lidocaine 0.05 MG/MG Topical OintmentSCDc66b3509-c670-4124-86ac-da313958aabd1
1543069lidocaine 5 % Topical OintmentSYc66b3509-c670-4124-86ac-da313958aabd1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
57539-0221-15753902210150 g in 1 JAR50 gHistorical
57539-0221-55753902210535.44 g in 1 TUBE35.44 gHistorical