FDA.reportPublic FDA data

Lidocaine

Product NDC
0603-1880
11-digit product format
006031880
Labeler code
0603
Product ID
0603-1880_671190d5-5921-4819-b2e3-8bcf3774d540
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lidocaine
Dosage form
PATCH
Route
CUTANEOUS
Labeler
Endo USA, Inc.
Application
NDA020612
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2014-05-02
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
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
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
0603-1880-10Lidocaine0.7 g in 1 POUCHPATCH0.723
0603-1880-16Lidocaine30 in 1 CARTONPATCH3023

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0603-1880LIDOCAINE PATCH [ENDO USA, INC.]23Current NDC, Legacy NDC, 2 package rows20250109_2ce8a4fe-8aa6-4dc5-ad0f-3984ae68c4bc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1745091lidocaine 5 % Medicated PatchPSN65cf652c-87f2-43c6-a6f8-e4a83b42ce78102
1745091lidocaine 0.05 MG/MG Medicated PatchSCD65cf652c-87f2-43c6-a6f8-e4a83b42ce78102
1745091lidocaine 5 % Medicated PatchSY65cf652c-87f2-43c6-a6f8-e4a83b42ce78102
1745091lidocaine 5 % Medicated PatchPSN2ce8a4fe-8aa6-4dc5-ad0f-3984ae68c4bc23
1745091lidocaine 0.05 MG/MG Medicated PatchSCD2ce8a4fe-8aa6-4dc5-ad0f-3984ae68c4bc23
1745091lidocaine 5 % Medicated PatchSY2ce8a4fe-8aa6-4dc5-ad0f-3984ae68c4bc23
1745091lidocaine 5 % Medicated PatchPSNe23a92e6-3445-4ba7-9ad2-86a3eec1717e17
1745091lidocaine 0.05 MG/MG Medicated PatchSCDe23a92e6-3445-4ba7-9ad2-86a3eec1717e17
1745091lidocaine 5 % Medicated PatchSYe23a92e6-3445-4ba7-9ad2-86a3eec1717e17
1745091lidocaine 5 % Medicated PatchPSN323e0ec2-c2e5-47d1-a39f-69ff5c99e32410
1745091lidocaine 5 % Medicated PatchPSNfa69dfdf-ab73-48a9-944d-25e88d7766df10
1745091lidocaine 0.05 MG/MG Medicated PatchSCD323e0ec2-c2e5-47d1-a39f-69ff5c99e32410
1745091lidocaine 0.05 MG/MG Medicated PatchSCDfa69dfdf-ab73-48a9-944d-25e88d7766df10
1745091lidocaine 5 % Medicated PatchSYfa69dfdf-ab73-48a9-944d-25e88d7766df10
1745091lidocaine 5 % Medicated PatchSY323e0ec2-c2e5-47d1-a39f-69ff5c99e32410
1745091lidocaine 5 % Medicated PatchPSNf20ab860-e49a-4f3f-868e-6a60780af5a75
1745091lidocaine 5 % Medicated PatchPSN94ab1b99-e203-4a14-b852-42d3b37999c35
1745091lidocaine 0.05 MG/MG Medicated PatchSCDf20ab860-e49a-4f3f-868e-6a60780af5a75
1745091lidocaine 0.05 MG/MG Medicated PatchSCD94ab1b99-e203-4a14-b852-42d3b37999c35
1745091lidocaine 5 % Medicated PatchSYf20ab860-e49a-4f3f-868e-6a60780af5a75
1745091lidocaine 5 % Medicated PatchSY94ab1b99-e203-4a14-b852-42d3b37999c35
1745091lidocaine 5 % Medicated PatchPSN1b561cc6-1d36-e259-e063-6294a90aacbd3
1745091lidocaine 0.05 MG/MG Medicated PatchSCD1b561cc6-1d36-e259-e063-6294a90aacbd3
1745091lidocaine 5 % Medicated PatchSY1b561cc6-1d36-e259-e063-6294a90aacbd3
1745091lidocaine 5 % Medicated PatchPSN3c69e03c-e176-2c23-e063-6394a90aa41f2
1745091lidocaine 5 % Medicated PatchPSNa575bcb8-478f-1f7e-e053-2995a90a4b122
1745091lidocaine 5 % Medicated PatchPSN9dc3059c-3a3d-5810-e053-2a95a90ab0ba2
1745091lidocaine 0.05 MG/MG Medicated PatchSCD3c69e03c-e176-2c23-e063-6394a90aa41f2
1745091lidocaine 0.05 MG/MG Medicated PatchSCD9dc3059c-3a3d-5810-e053-2a95a90ab0ba2
1745091lidocaine 0.05 MG/MG Medicated PatchSCDa575bcb8-478f-1f7e-e053-2995a90a4b122
1745091lidocaine 5 % Medicated PatchSY9dc3059c-3a3d-5810-e053-2a95a90ab0ba2
1745091lidocaine 5 % Medicated PatchSY3c69e03c-e176-2c23-e063-6394a90aa41f2
1745091lidocaine 5 % Medicated PatchSYa575bcb8-478f-1f7e-e053-2995a90a4b122
1745091lidocaine 5 % Medicated PatchPSNf7ada189-7463-4bc7-83e7-f140558ecacf1
1745091lidocaine 5 % Medicated PatchPSN0748b9e3-1247-4eeb-8158-3d641b2ad85d1
1745091lidocaine 5 % Medicated PatchPSN2f1e77e1-86b6-635e-e054-00144ff88e881
1745091lidocaine 5 % Medicated PatchPSNc59978b7-50ad-affe-e053-2995a90a99cb1
1745091lidocaine 5 % Medicated PatchPSN4611f0da-a41d-4861-9dd6-f16f1b007d331
1745091lidocaine 0.05 MG/MG Medicated PatchSCD2f1e77e1-86b6-635e-e054-00144ff88e881
1745091lidocaine 0.05 MG/MG Medicated PatchSCDc59978b7-50ad-affe-e053-2995a90a99cb1
1745091lidocaine 0.05 MG/MG Medicated PatchSCD0748b9e3-1247-4eeb-8158-3d641b2ad85d1
1745091lidocaine 0.05 MG/MG Medicated PatchSCDf7ada189-7463-4bc7-83e7-f140558ecacf1
1745091lidocaine 0.05 MG/MG Medicated PatchSCD4611f0da-a41d-4861-9dd6-f16f1b007d331
1745091lidocaine 5 % Medicated PatchSYc59978b7-50ad-affe-e053-2995a90a99cb1
1745091lidocaine 5 % Medicated PatchSY2f1e77e1-86b6-635e-e054-00144ff88e881
1745091lidocaine 5 % Medicated PatchSY4611f0da-a41d-4861-9dd6-f16f1b007d331
1745091lidocaine 5 % Medicated PatchSYf7ada189-7463-4bc7-83e7-f140558ecacf1
1745091lidocaine 5 % Medicated PatchSY0748b9e3-1247-4eeb-8158-3d641b2ad85d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0603-1880-10006031880100.7 g in 1 POUCH0.7 gHistorical
0603-1880-160060318801630 POUCH in 1 CARTON (0603-1880-16) / .7 g in 1 POUCH (0603-1880-10) 30 pouch2014-05-020000-00-00NoNoCurrent