FDA.reportPublic FDA data

Lidocaine

Product NDC
65162-791
11-digit product format
651620791
Labeler code
65162
Product ID
65162-791_fb8b65ae-be7d-4c1a-9a13-38258ef15c90
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine
Dosage form
PATCH
Route
TOPICAL
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA206463
Marketing category
ANDA
Marketing start
2020-08-25
Substance
LIDOCAINE
Active strength
700 mg/1
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
LIDOCAINE700 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii98PI200987
Rxcui1745091

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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
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
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65162-791-04Lidocaine1 in 1 POUCHPATCH117
65162-791-08Lidocaine30 in 1 CARTONPATCH3017
65162-791-08Elemar Patch30 in 1 CARTONPATCH700 mg12
65162-791-08Elemar Patch1 in 1 POUCHPATCH30700 mg12
65162-791-04LMR Plus1 in 1 POUCHPATCH30700 mg11
65162-791-08LMR Plus30 in 1 CARTONPATCH700 mg11
65162-791-08Orvex1 in 1 POUCHPATCH30700 mg4
65162-791-08Orvex30 in 1 CARTONPATCH700 mg4
65162-791-08Syntherma Plus1 in 1 POUCHPATCH30700 mg1
65162-791-08Syntherma Plus30 in 1 CARTONPATCH700 mg1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65162-791LIDOCAINE PATCH [AMNEAL PHARMACEUTICALS LLC]17Current NDC, Legacy NDC, 2 package rows20250427_1f46bdfd-3a38-49a3-a505-0192790486d0.zip
65162-791LMR PLUS (LIDOCAINE) KIT [V2 PHARMA, LLC]11Current NDC, Legacy NDC20250101_7c84e443-67fe-40b5-b721-86e9e7c4d490.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1745091lidocaine 5 % Medicated PatchPSNb4db5684-988f-44c4-a81e-5c04b8b0f6e7102
1745091lidocaine 0.05 MG/MG Medicated PatchSCDb4db5684-988f-44c4-a81e-5c04b8b0f6e7102
1745091lidocaine 5 % Medicated PatchSYb4db5684-988f-44c4-a81e-5c04b8b0f6e7102
1745091lidocaine 5 % Medicated PatchPSN19c585f3-e635-44d4-8eb0-14529eb34dca101
1745091lidocaine 0.05 MG/MG Medicated PatchSCD19c585f3-e635-44d4-8eb0-14529eb34dca101
1745091lidocaine 5 % Medicated PatchSY19c585f3-e635-44d4-8eb0-14529eb34dca101
1745091lidocaine 5 % Medicated PatchPSN1f46bdfd-3a38-49a3-a505-0192790486d017
1745091lidocaine 0.05 MG/MG Medicated PatchSCD1f46bdfd-3a38-49a3-a505-0192790486d017
1745091lidocaine 5 % Medicated PatchSY1f46bdfd-3a38-49a3-a505-0192790486d017
1745091lidocaine 5 % Medicated PatchPSN3de6bb95-3673-45c4-bf11-90ec858c37d912
415976menthol 6 % Topical GelPSN3de6bb95-3673-45c4-bf11-90ec858c37d912
1745091lidocaine 0.05 MG/MG Medicated PatchSCD3de6bb95-3673-45c4-bf11-90ec858c37d912
415976menthol 0.06 MG/MG Topical GelSCD3de6bb95-3673-45c4-bf11-90ec858c37d912
1745091lidocaine 5 % Medicated PatchSY3de6bb95-3673-45c4-bf11-90ec858c37d912
415976menthol 6 % Topical GelSY3de6bb95-3673-45c4-bf11-90ec858c37d912
1745091lidocaine 5 % Medicated PatchPSN7c84e443-67fe-40b5-b721-86e9e7c4d49011
415976menthol 6 % Topical GelPSN7c84e443-67fe-40b5-b721-86e9e7c4d49011
1745091lidocaine 0.05 MG/MG Medicated PatchSCD7c84e443-67fe-40b5-b721-86e9e7c4d49011
415976menthol 0.06 MG/MG Topical GelSCD7c84e443-67fe-40b5-b721-86e9e7c4d49011
1745091lidocaine 5 % Medicated PatchSY7c84e443-67fe-40b5-b721-86e9e7c4d49011
415976menthol 6 % Topical GelSY7c84e443-67fe-40b5-b721-86e9e7c4d49011
1745091lidocaine 5 % Medicated PatchPSN3dd9a87e-9860-461a-b9ce-042942de839f4
1745091lidocaine 5 % Medicated PatchPSNebc05cf9-e82b-4f7d-b5e7-3e62025ce68c4
415976menthol 6 % Topical GelPSN3dd9a87e-9860-461a-b9ce-042942de839f4
1745091lidocaine 0.05 MG/MG Medicated PatchSCD3dd9a87e-9860-461a-b9ce-042942de839f4
1745091lidocaine 0.05 MG/MG Medicated PatchSCDebc05cf9-e82b-4f7d-b5e7-3e62025ce68c4
415976menthol 0.06 MG/MG Topical GelSCD3dd9a87e-9860-461a-b9ce-042942de839f4
1745091lidocaine 5 % Medicated PatchSY3dd9a87e-9860-461a-b9ce-042942de839f4
1745091lidocaine 5 % Medicated PatchSYebc05cf9-e82b-4f7d-b5e7-3e62025ce68c4
415976menthol 6 % Topical GelSY3dd9a87e-9860-461a-b9ce-042942de839f4
1745091lidocaine 5 % Medicated PatchPSNeb503f1f-cd3a-ab76-e053-2995a90ab1c83
1745091lidocaine 0.05 MG/MG Medicated PatchSCDeb503f1f-cd3a-ab76-e053-2995a90ab1c83
1745091lidocaine 5 % Medicated PatchSYeb503f1f-cd3a-ab76-e053-2995a90ab1c83
1745091lidocaine 5 % Medicated PatchPSNf94d388c-8471-885b-e053-6294a90ab67a2
1745091lidocaine 0.05 MG/MG Medicated PatchSCDf94d388c-8471-885b-e053-6294a90ab67a2
1745091lidocaine 5 % Medicated PatchSYf94d388c-8471-885b-e053-6294a90ab67a2
1745091lidocaine 5 % Medicated PatchPSN82bb7767-5407-4593-b6d4-90859890e3761
1745091lidocaine 5 % Medicated PatchPSN1a312322-9c4a-4f14-be7f-05ccad1601bf1
1745091lidocaine 5 % Medicated PatchPSN1112681c-8de7-472b-8db4-2702054b835b1
415976menthol 6 % Topical GelPSN1a312322-9c4a-4f14-be7f-05ccad1601bf1
1745091lidocaine 0.05 MG/MG Medicated PatchSCD82bb7767-5407-4593-b6d4-90859890e3761
1745091lidocaine 0.05 MG/MG Medicated PatchSCD1a312322-9c4a-4f14-be7f-05ccad1601bf1
1745091lidocaine 0.05 MG/MG Medicated PatchSCD1112681c-8de7-472b-8db4-2702054b835b1
415976menthol 0.06 MG/MG Topical GelSCD1a312322-9c4a-4f14-be7f-05ccad1601bf1
1745091lidocaine 5 % Medicated PatchSY82bb7767-5407-4593-b6d4-90859890e3761
1745091lidocaine 5 % Medicated PatchSY1a312322-9c4a-4f14-be7f-05ccad1601bf1
1745091lidocaine 5 % Medicated PatchSY1112681c-8de7-472b-8db4-2702054b835b1
415976menthol 6 % Topical GelSY1a312322-9c4a-4f14-be7f-05ccad1601bf1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65162-791-04651620791041 in 1 POUCHHistorical
65162-791-086516207910830 POUCH in 1 CARTON (65162-791-08) / 1 PATCH in 1 POUCH (65162-791-04) 30 pouch2020-08-250000-00-00NoNoCurrent