FDA.reportPublic FDA data

Lidocaine

Product NDC
0168-0204
11-digit product format
001680204
Labeler code
0168
Product ID
0168-0204_76e9f389-e9f0-4568-8b13-74c9dd831001
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Fougera Pharmaceuticals, LLC
Application
ANDA080198
Marketing category
ANDA
Marketing start
1972-06-30
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Lidocaine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE50 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii98PI200987
Rxcui1543069

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
0168-0204-372021-01-25C16284748780-1ab0e2407-347f-f274-e053-dbdaa90a6471LIDOCAINE OINTMENT USP, 5%
0168-0204-372020-09-27C16284748780-1ab0e2407-347f-f274-e053-dbdaa90a6471LIDOCAINE OINTMENT USP, 5%
0168-0204-372020-09-25C16284748780-1ab0e2407-347f-f274-e053-dbdaa90a6471LIDOCAINE OINTMENT USP, 5%
0168-0204-372020-07-22C16284748780-1ab0e2407-347f-f274-e053-dbdaa90a6471LIDOCAINE OINTMENT USP, 5%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0168-0204-37Lidocaine35.44 g in 1 TUBEOINTMENT35.4411
0168-0204-37Lidocaine1 in 1 CARTONOINTMENT111

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0168-0204-37GM - Gram0168-020435c62859-1d06-4f09-93c7-61d8ac84ca7812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
lidocaineACTIVE INGREDIENT98PI200987LIDOCAINE OINTMENT [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]4
lidocaineACTIVE MOIETY98PI200987LIDOCAINE OINTMENT [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]4
polyethylene glycol 1450INACTIVE INGREDIENTOJ4Z5Z32L4LIDOCAINE OINTMENT [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]4
polyethylene glycol 300INACTIVE INGREDIENT5655G9Y8AQLIDOCAINE OINTMENT [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]4
LIDOCAINEACTIVE INGREDIENT98PI200987LIDOCAINE OINTMENT [AIDAREX PHARMACEUTICALS LLC]1
lidocaineACTIVE INGREDIENT98PI200987LIDOCAINE OINTMENT [REBEL DISTRIBUTORS CORP]1
LIDOCAINEACTIVE MOIETY98PI200987LIDOCAINE OINTMENT [AIDAREX PHARMACEUTICALS LLC]1
lidocaineACTIVE MOIETY98PI200987LIDOCAINE OINTMENT [REBEL DISTRIBUTORS CORP]1
POLYETHYLENE GLYCOL 1450INACTIVE INGREDIENTOJ4Z5Z32L4LIDOCAINE OINTMENT [AIDAREX PHARMACEUTICALS LLC]1
polyethylene glycol 1450INACTIVE INGREDIENTOJ4Z5Z32L4LIDOCAINE OINTMENT [REBEL DISTRIBUTORS CORP]1
POLYETHYLENE GLYCOL 300INACTIVE INGREDIENT5655G9Y8AQLIDOCAINE OINTMENT [AIDAREX PHARMACEUTICALS LLC]1
polyethylene glycol 300INACTIVE INGREDIENT5655G9Y8AQLIDOCAINE OINTMENT [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0168-0204LIDOCAINE OINTMENT [FOUGERA PHARMACEUTICALS INC.]10Current NDC, Legacy NDC, 2 package rows20240601_88ca9cba-0c4a-482f-b502-ceefdb1bfbcd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1543069lidocaine 5 % Topical OintmentPSN88ca9cba-0c4a-482f-b502-ceefdb1bfbcd11
1543069lidocaine 0.05 MG/MG Topical OintmentSCD88ca9cba-0c4a-482f-b502-ceefdb1bfbcd11
1543069lidocaine 5 % Topical OintmentSY88ca9cba-0c4a-482f-b502-ceefdb1bfbcd11
1543069lidocaine 5 % Topical OintmentPSN670287ac-9d8d-4514-b433-4adcca2d915a1
1543069lidocaine 5 % Topical OintmentPSNa1e2c14f-0682-4b19-9159-de0aca1960c61
1543069lidocaine 0.05 MG/MG Topical OintmentSCD670287ac-9d8d-4514-b433-4adcca2d915a1
1543069lidocaine 0.05 MG/MG Topical OintmentSCDa1e2c14f-0682-4b19-9159-de0aca1960c61
1543069lidocaine 5 % Topical OintmentSY670287ac-9d8d-4514-b433-4adcca2d915a1
1543069lidocaine 5 % Topical OintmentSYa1e2c14f-0682-4b19-9159-de0aca1960c61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0168-0204-37001680204371 TUBE in 1 CARTON (0168-0204-37) / 35.44 g in 1 TUBE1 tube1972-06-300000-00-00NoNoCurrent