FDA.reportPublic FDA data

Lidocaine

Product NDC
70752-113
11-digit product format
707520113
Labeler code
70752
Product ID
70752-113_99e31c06-b379-4dfe-84e3-b810376bccd2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine
Dosage form
OINTMENT
Route
TOPICAL
Labeler
QUAGEN PHARMACEUTICALS LLC
Application
ANDA212695
Marketing category
ANDA
Marketing start
2021-04-20
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Lidocaine
Listing expiration
2026-12-31

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
70752-113-032023-02-15C16284748780-1f386c649-b876-0266-e053-dadaa90a7c1aLidocaine Ointment USP, 5% FOR TOPICAL USE DO NOT USE IN THE EYES Rx Only
70752-113-042023-02-15C16284748780-1f386c649-b876-0266-e053-dadaa90a7c1aLidocaine Ointment USP, 5% FOR TOPICAL USE DO NOT USE IN THE EYES Rx Only
70752-113-072023-02-15C16284748780-1f386c649-b876-0266-e053-dadaa90a7c1aLidocaine Ointment USP, 5% FOR TOPICAL USE DO NOT USE IN THE EYES Rx Only
70752-113-132023-02-15C16284748780-1f386c649-b876-0266-e053-dadaa90a7c1aLidocaine Ointment USP, 5% FOR TOPICAL USE DO NOT USE IN THE EYES Rx Only
70752-113-032023-01-30C16284748780-1f386c649-b876-0266-e053-dadaa90a7c1aLidocaine Ointment USP, 5% FOR TOPICAL USE DO NOT USE IN THE EYES Rx Only
70752-113-042023-01-30C16284748780-1f386c649-b876-0266-e053-dadaa90a7c1aLidocaine Ointment USP, 5% FOR TOPICAL USE DO NOT USE IN THE EYES Rx Only
70752-113-072023-01-30C16284748780-1f386c649-b876-0266-e053-dadaa90a7c1aLidocaine Ointment USP, 5% FOR TOPICAL USE DO NOT USE IN THE EYES Rx Only
70752-113-132023-01-30C16284748780-1f386c649-b876-0266-e053-dadaa90a7c1aLidocaine Ointment USP, 5% FOR TOPICAL USE DO NOT USE IN THE EYES Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70752-113-03Lidocaine1 in 1 CARTONOINTMENT12
70752-113-03Lidocaine35.44 g in 1 TUBEOINTMENT35.442
70752-113-04Lidocaine50 g in 1 JAROINTMENT502
70752-113-07Lidocaine150 g in 1 JAROINTMENT1502
70752-113-13Lidocaine250 g in 1 JAROINTMENT2502

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70752-113-03GM - Gram70752-1137ef5ea2e-302a-4ac9-9cd3-782ede2f2a1f12021-11-09
70752-113-04GM - Gram70752-1133196dfdf-ae19-4914-9d4c-aa1fa9cf599612021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70752-113LIDOCAINE OINTMENT [QUAGEN PHARMACEUTICALS LLC]2Current NDC, Legacy NDC, 5 package rows20230217_f8789807-cc0c-485c-aa98-1bdc39337deb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1543069lidocaine 5 % Topical OintmentPSN015cea25-d323-43dd-a92f-593a8e4a2921101
1543069lidocaine 0.05 MG/MG Topical OintmentSCD015cea25-d323-43dd-a92f-593a8e4a2921101
1543069lidocaine 5 % Topical OintmentSY015cea25-d323-43dd-a92f-593a8e4a2921101
1543069lidocaine 5 % Topical OintmentPSN4e679a0d-df82-435f-ad46-c871f3c76dfb100
1543069lidocaine 0.05 MG/MG Topical OintmentSCD4e679a0d-df82-435f-ad46-c871f3c76dfb100
1543069lidocaine 5 % Topical OintmentSY4e679a0d-df82-435f-ad46-c871f3c76dfb100
1543069lidocaine 5 % Topical OintmentPSN29f211ff-dcba-afb0-e063-6294a90afb9b2
1543069lidocaine 5 % Topical OintmentPSN325ddb61-84f5-075c-e063-6294a90ad5e92
1543069lidocaine 5 % Topical OintmentPSNf8789807-cc0c-485c-aa98-1bdc39337deb2
1543069lidocaine 0.05 MG/MG Topical OintmentSCD29f211ff-dcba-afb0-e063-6294a90afb9b2
1543069lidocaine 0.05 MG/MG Topical OintmentSCD325ddb61-84f5-075c-e063-6294a90ad5e92
1543069lidocaine 0.05 MG/MG Topical OintmentSCDf8789807-cc0c-485c-aa98-1bdc39337deb2
1543069lidocaine 5 % Topical OintmentSY29f211ff-dcba-afb0-e063-6294a90afb9b2
1543069lidocaine 5 % Topical OintmentSY325ddb61-84f5-075c-e063-6294a90ad5e92
1543069lidocaine 5 % Topical OintmentSYf8789807-cc0c-485c-aa98-1bdc39337deb2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70752-113-03707520113031 TUBE in 1 CARTON (70752-113-03) / 35.44 g in 1 TUBE1 tube2021-04-200000-00-00NoNoCurrent
70752-113-047075201130450 g in 1 JAR (70752-113-04) 50 g2021-04-200000-00-00NoNoCurrent
70752-113-0770752011307150 g in 1 JAR (70752-113-07) 150 g2021-04-200000-00-00NoNoCurrent
70752-113-1370752011313250 g in 1 JAR (70752-113-13) 250 g2021-04-200000-00-00NoNoCurrent