FDA.reportPublic FDA data

Lidocaine

Product NDC
65162-918
11-digit product format
651620918
Labeler code
65162
Product ID
65162-918_1f3288ac-58b0-4278-aed2-51cc99724d9b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA206297
Marketing category
ANDA
Marketing start
2015-08-10
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65162-918-30Lidocaine30 g in 1 TUBEOINTMENT3022
65162-918-30Lidocaine1 in 1 CARTONOINTMENT122
65162-918-38Lidocaine1 in 1 CARTONOINTMENT122
65162-918-38Lidocaine35.44 g in 1 TUBEOINTMENT35.4422
65162-918-53Lidocaine50 g in 1 JAROINTMENT5022
65162-918-41Lidocaine150 g in 1 JAROINTMENT15010
65162-918-45Lidocaine250 g in 1 JAROINTMENT25010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65162-918-38GM - Gram65162-9188230b9f9-3f32-4a90-85e9-206c918005e012015-11-12
65162-918-41GM - Gram65162-918bfa0e4e5-bafc-4485-861b-b70bbe8da3d912017-07-07
65162-918-45GM - Gram65162-91826929407-0f83-4b0b-8ae6-bab1f98e158712017-07-07
65162-918-53GM - Gram65162-9186770a7f2-7d8a-4c05-a329-c8e7accb446312015-11-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LIDOCAINEACTIVE INGREDIENT98PI200987LIDOCAINE OINTMENT [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]5
LIDOCAINEACTIVE MOIETY98PI200987LIDOCAINE OINTMENT [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]5
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ALIDOCAINE OINTMENT [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65162-918LIDOCAINE OINTMENT [AMNEAL PHARMACEUTICALS LLC]22Current NDC, Legacy NDC, 5 package rows20241030_d1509740-f9f1-44e3-8fde-51d8683fcd87.zip
65162-918LIDOCAINE OINTMENT [AMNEAL PHARMACEUTICALS LLC]10Current NDC, Legacy NDC, 2 package rows20241030_960f6d0a-82af-45e9-89d5-cea808004ebb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1543069lidocaine 5 % Topical OintmentPSN6fe7721d-42b3-4284-936b-a448ca530c45100
1543069lidocaine 0.05 MG/MG Topical OintmentSCD6fe7721d-42b3-4284-936b-a448ca530c45100
1543069lidocaine 5 % Topical OintmentSY6fe7721d-42b3-4284-936b-a448ca530c45100
1543069lidocaine 5 % Topical OintmentPSNd1509740-f9f1-44e3-8fde-51d8683fcd8722
1543069lidocaine 0.05 MG/MG Topical OintmentSCDd1509740-f9f1-44e3-8fde-51d8683fcd8722
1543069lidocaine 5 % Topical OintmentSYd1509740-f9f1-44e3-8fde-51d8683fcd8722
1543069lidocaine 5 % Topical OintmentPSN4806f94d-cbac-4107-b93b-8f715868ffb311
1543069lidocaine 0.05 MG/MG Topical OintmentSCD4806f94d-cbac-4107-b93b-8f715868ffb311
1543069lidocaine 5 % Topical OintmentSY4806f94d-cbac-4107-b93b-8f715868ffb311
1543069lidocaine 5 % Topical OintmentPSN960f6d0a-82af-45e9-89d5-cea808004ebb10
1543069lidocaine 0.05 MG/MG Topical OintmentSCD960f6d0a-82af-45e9-89d5-cea808004ebb10
1543069lidocaine 5 % Topical OintmentSY960f6d0a-82af-45e9-89d5-cea808004ebb10
1543069lidocaine 5 % Topical OintmentPSNf18b8413-8f52-a927-e053-2a95a90a402a3
1543069lidocaine 0.05 MG/MG Topical OintmentSCDf18b8413-8f52-a927-e053-2a95a90a402a3
1543069lidocaine 5 % Topical OintmentSYf18b8413-8f52-a927-e053-2a95a90a402a3
1543069lidocaine 5 % Topical OintmentPSN51c903ae-c92a-4edf-b179-c52c730aec592
1543069lidocaine 5 % Topical OintmentPSNf93cbde5-329a-f880-e053-6294a90a1af22
1543069lidocaine 5 % Topical OintmentPSN40949067-a5a8-db8c-e063-6294a90af0fb2
1543069lidocaine 0.05 MG/MG Topical OintmentSCD40949067-a5a8-db8c-e063-6294a90af0fb2
1543069lidocaine 0.05 MG/MG Topical OintmentSCDf93cbde5-329a-f880-e053-6294a90a1af22
1543069lidocaine 0.05 MG/MG Topical OintmentSCD51c903ae-c92a-4edf-b179-c52c730aec592
1543069lidocaine 5 % Topical OintmentSYf93cbde5-329a-f880-e053-6294a90a1af22
1543069lidocaine 5 % Topical OintmentSY51c903ae-c92a-4edf-b179-c52c730aec592
1543069lidocaine 5 % Topical OintmentSY40949067-a5a8-db8c-e063-6294a90af0fb2
1543069lidocaine 5 % Topical OintmentPSN9addc699-fd91-9c84-e053-2995a90aff471
1543069lidocaine 0.05 MG/MG Topical OintmentSCD9addc699-fd91-9c84-e053-2995a90aff471
1543069lidocaine 5 % Topical OintmentSY9addc699-fd91-9c84-e053-2995a90aff471

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65162-918-30651620918301 TUBE in 1 CARTON (65162-918-30) / 30 g in 1 TUBE1 tube2015-08-100000-00-00NoNoCurrent
65162-918-38651620918381 TUBE in 1 CARTON (65162-918-38) / 35.44 g in 1 TUBE1 tube2015-08-100000-00-00NoNoCurrent
65162-918-4165162091841150 g in 1 JAR (65162-918-41) 150 g2015-08-100000-00-00NoNoCurrent
65162-918-4565162091845250 g in 1 JAR (65162-918-45) 250 g2015-08-100000-00-00NoNoCurrent
65162-918-536516209185350 g in 1 JAR (65162-918-53) 50 g2015-08-100000-00-00NoNoCurrent