FDA.reportPublic FDA data

Lidocaine

Product NDC
33342-405
11-digit product format
333420405
Labeler code
33342
Product ID
33342-405_17ec3534-2297-4eaa-8383-b8f028670702
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Macleods Pharmaceuticals Limited
Application
ANDA211697
Marketing category
ANDA
Marketing start
2021-03-01
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33342-405-30Lidocaine1 in 1 CARTONOINTMENT13
33342-405-30Lidocaine30 g in 1 TUBEOINTMENT303
33342-405-35Lidocaine1 in 1 CARTONOINTMENT13
33342-405-35Lidocaine35.44 g in 1 TUBEOINTMENT35.443
33342-405-44Lidocaine50 g in 1 JAROINTMENT503
33342-405-50Lidocaine1 in 1 CARTONOINTMENT13
33342-405-50Lidocaine50 g in 1 TUBEOINTMENT503

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33342-405-30GM - Gram33342-405ca4765d4-897e-4203-8e24-47957934549312021-06-02
33342-405-35GM - Gram33342-40511bcafd3-04f0-41ee-af1d-48e266f2f12a12021-06-02
33342-405-50GM - Gram33342-4052d672294-432b-4975-afd6-04e6768bf64c12021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33342-405LIDOCAINE OINTMENT [MACLEODS PHARMACEUTICALS LIMITED]2Current NDC, Legacy NDC, 7 package rows20230202_c788afd3-4554-40c4-8f26-2c31ab9b9b98.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1543069lidocaine 5 % Topical OintmentPSN9bf01533-ed83-4440-bdc4-4b45729bfc314
1543069lidocaine 0.05 MG/MG Topical OintmentSCD9bf01533-ed83-4440-bdc4-4b45729bfc314
1543069lidocaine 5 % Topical OintmentSY9bf01533-ed83-4440-bdc4-4b45729bfc314
1543069lidocaine 5 % Topical OintmentPSNc788afd3-4554-40c4-8f26-2c31ab9b9b983
1543069lidocaine 0.05 MG/MG Topical OintmentSCDc788afd3-4554-40c4-8f26-2c31ab9b9b983
1543069lidocaine 5 % Topical OintmentSYc788afd3-4554-40c4-8f26-2c31ab9b9b983
1543069lidocaine 5 % Topical OintmentPSNfd8a640a-b5ca-f0a7-e053-6394a90ad6032
1543069lidocaine 0.05 MG/MG Topical OintmentSCDfd8a640a-b5ca-f0a7-e053-6394a90ad6032
1543069lidocaine 5 % Topical OintmentSYfd8a640a-b5ca-f0a7-e053-6394a90ad6032
1543069lidocaine 5 % Topical OintmentPSNe0bfe16f-7a3f-48e0-a2e6-2ec68159a8881
1543069lidocaine 0.05 MG/MG Topical OintmentSCDe0bfe16f-7a3f-48e0-a2e6-2ec68159a8881
1543069lidocaine 5 % Topical OintmentSYe0bfe16f-7a3f-48e0-a2e6-2ec68159a8881

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
33342-405-30333420405301 TUBE in 1 CARTON (33342-405-30) / 30 g in 1 TUBE1 tube2021-03-010000-00-00NoNoCurrent
33342-405-35333420405351 TUBE in 1 CARTON (33342-405-35) / 35.44 g in 1 TUBE1 tube2021-03-010000-00-00NoNoCurrent
33342-405-443334204054450 g in 1 JAR (33342-405-44) 50 g2025-11-18NoNoHistorical
33342-405-50333420405501 TUBE in 1 CARTON (33342-405-50) / 50 g in 1 TUBE1 tube2021-03-010000-00-00NoNoCurrent