LIDOCAINE

Product NDC
76282-669
Requested package NDC
76282-669-41
11-digit product format
762820669
Labeler code
76282
Product ID
76282-669_10f235b8-dc08-410e-933d-aeed4768c988
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LIDOCAINE
Dosage form
PATCH
Route
CUTANEOUS
Labeler
EXELAN PHARMACEUTICALS, INC.
Application
ANDA205882
Marketing category
ANDA
Marketing start
2021-10-22
Marketing end
0000-00-00
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
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage76282-66976282-669-41IInactivated by FDA2026-09-09

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A205882-001LIDOCAINELIDOCAINE5%PATCH / TOPICALAB2021-04-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A205882-001AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A205882-001LIDOCAINE5%PATCH / TOPICALAB2021-04-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A205882-001LIDOCAINE5%PATCH / TOPICALAB2021-04-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205882-001LIDOCAINE5%PATCH / TOPICALAB2021-04-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A205882-001LIDOCAINE5%PATCH / TOPICALAB2021-04-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205882-001LIDOCAINE5%PATCH / TOPICALAB2021-04-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205882-001LIDOCAINE5%PATCH / TOPICALAB2021-04-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205882-001LIDOCAINE5%PATCH / TOPICALAB2021-04-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205882-001LIDOCAINE5%PATCH / TOPICALAB2021-04-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205882-001LIDOCAINE5%PATCH / TOPICALAB2021-04-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205882-001LIDOCAINE5%PATCH / TOPICALAB2021-04-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205882-001LIDOCAINE5%PATCH / TOPICALAB2021-04-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205882-001LIDOCAINE5%PATCH / TOPICALAB2021-04-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205882-001LIDOCAINE5%PATCH / TOPICALAB2021-04-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205882-001LIDOCAINE5%PATCH / TOPICALAB2021-04-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205882-001LIDOCAINE5%PATCH / TOPICALAB2021-04-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205882-001LIDOCAINE5%PATCH / TOPICALAB2021-04-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A205882-001LIDOCAINE5%PATCH / TOPICALAB2021-04-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A205882-001LIDOCAINE5%PATCH / TOPICALAB2021-04-294b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A205882-001LIDOCAINE5%PATCH / TOPICALAB2021-04-29bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A205882-001LIDOCAINE5%PATCH / TOPICALAB2021-04-29782e0a99824c…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A205882-001LIDOCAINE5%PATCH / TOPICALAB2021-04-296a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A205882-001LIDOCAINE5%PATCH / TOPICALAB2021-04-291c564ffb4f44…
2023-12-20 04:57 UTC2023-12A205882-001LIDOCAINE5%PATCH / TOPICALAB2021-04-29ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A205882-001LIDOCAINE5%PATCH / TOPICALAB2021-04-29a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A205882-001LIDOCAINE5%PATCH / TOPICALAB2021-04-299b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A205882-001LIDOCAINE5%PATCH / TOPICALAB2021-04-29a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A205882-001LIDOCAINE5%PATCH / TOPICALAB2021-04-293f0d92c62455…
2023-05-13 08:27 UTC2023-05A205882-001LIDOCAINE5%PATCH / TOPICALAB2021-04-29053a50430f4f…
2023-01-26 05:58 UTC2023-01A205882-001LIDOCAINE5%PATCH / TOPICALAB2021-04-293bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A205882-001LIDOCAINE5%PATCH / TOPICALAB2021-04-293a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A205882-001LIDOCAINE5%PATCH / TOPICALAB2021-04-29f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A205882-001LIDOCAINE5%PATCH / TOPICALAB2021-04-29e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A205882-001LIDOCAINE5%PATCH / TOPICALAB2021-04-29cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A205882-001LIDOCAINE5%PATCH / TOPICALAB2021-04-29a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A205882-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A205882-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205882-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A205882-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205882-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205882-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205882-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205882-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205882-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205882-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205882-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205882-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205882-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205882-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205882-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205882-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A205882-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A205882-001AB14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A205882-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A205882-001AB1782e0a99824c…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A205882-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A205882-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A205882-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A205882-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A205882-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A205882-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A205882-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A205882-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A205882-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A205882-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A205882-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A205882-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A205882-001AB1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A205882-001AB1a50c72e98297…

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76282-669-412024-01-30C16284748780-11030e365-55cc-111a-e063-dadaa90a10e2Lidocaine Patch 5% Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76282-669-40LIDOCAINE1 in 1 POUCHPATCH11
76282-669-41LIDOCAINE30 in 1 CARTONPATCH301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76282-669LIDOCAINE PATCH [EXELAN PHARMACEUTICALS, INC.]1Legacy NDC, 2 package rows20211103_1b0786e1-cd62-4a76-8866-f2206faea69a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1745091lidocaine 5 % Medicated PatchPSN1b0786e1-cd62-4a76-8866-f2206faea69a1
1745091lidocaine 0.05 MG/MG Medicated PatchSCD1b0786e1-cd62-4a76-8866-f2206faea69a1
1745091lidocaine 5 % Medicated PatchSY1b0786e1-cd62-4a76-8866-f2206faea69a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76282-669-417628206694130 POUCH in 1 CARTON (76282-669-41) > 1 PATCH in 1 POUCH (76282-669-40) 30 pouch2021-10-220000-00-00NoNoCurrent