Lidopac

Product NDC
69336-829
11-digit product format
693360829
Labeler code
69336
Product ID
69336-829_52bbdbbb-3298-4a9a-871c-9061bc55c759
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Sterling-Knight Pharmaceuticals, LLC
Application
ANDA206297
Marketing category
ANDA
Marketing start
2016-08-15
Marketing end
0000-00-00
Substance
LIDOCAINE
Active strength
50 mg/g
Pharmacologic classes
Amide Local Anesthetic [EPC],Amides [CS],Antiarrhythmic [EPC],Local Anesthesia [PE]
NDC exclude flag
E
Listing certified through
2018-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct69336-829IInactivated by FDA2026-08-17
excluded packagepackage69336-82969336-829-01IInactivated by FDA2026-08-17

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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage69336-829-01IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage69336-829-01IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage69336-829-01IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage69336-829-01IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage69336-829-01IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage69336-829-01IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage69336-829-01IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage69336-829-01IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage69336-829-01IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage69336-829-01IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage69336-829-01IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage69336-829-01IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage69336-829-01IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage69336-829-01IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage69336-829-01IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage69336-829-01IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage69336-829-01IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage69336-829-01IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage69336-829-01IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage69336-829-01IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage69336-829-01IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage69336-829-01EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

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
A206297-001LIDOCAINELIDOCAINE5%OINTMENT / TOPICALAT2015-08-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A206297-001AT

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.

Product history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-07caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-071e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-078072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-075c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-075d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-074b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-0774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-07bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-07782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-0787673890dc5c…
2021-03-12 10:30 UTC2021-03A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-075aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-078869cabd3fbd…
2020-11-12 02:37 UTC2020-11A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-07c0c555d07b60…
2019-12-14 00:12 UTC2019-12A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-073f01610625f2…
2019-09-15 20:21 UTC2019-09A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-07b00525d2431f…
2019-07-19 19:46 UTC2019-07A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-07ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-076a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-071c564ffb4f44…
2023-12-20 04:57 UTC2023-12A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-07ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-07a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-079b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-07a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-073f0d92c62455…
2023-05-13 08:27 UTC2023-05A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-07053a50430f4f…
2023-01-26 05:58 UTC2023-01A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-073bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-073a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-07f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A206297-001LIDOCAINE5%OINTMENT / TOPICALAT2015-08-07e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A206297-001AT1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A206297-001AT1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206297-001AT131067a03dcf5…
2025-08-23 18:47 UTC2025-08A206297-001AT16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206297-001AT1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206297-001AT1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206297-001AT103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206297-001AT12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206297-001AT15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206297-001AT1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206297-001AT1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206297-001AT179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206297-001AT1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206297-001AT11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206297-001AT18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206297-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206297-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206297-001AT14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A206297-001AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A206297-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A206297-001AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A206297-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03A206297-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A206297-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A206297-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A206297-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09A206297-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07A206297-001AT1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A206297-001AT16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A206297-001AT11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A206297-001AT1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A206297-001AT1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A206297-001AT19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A206297-001AT1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A206297-001AT13f0d92c62455…
2023-05-13 08:27 UTC2023-05A206297-001AT1053a50430f4f…
2023-01-26 05:58 UTC2023-01A206297-001AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A206297-001AT13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A206297-001AT1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A206297-001AT1e64feba35796…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69336-829-012020-01-31C16284748780-19d75b9d0-f526-f424-e053-dadaa90a57ceLidopac Lidocaine 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
69336-829-01Lidopac35.44 g in 1 TUBEOINTMENT35.449
69336-829-01Lidopac1 in 1 CARTONOINTMENT19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69336-829-01EA - Each69336-829e31a833e-90a1-449c-a0b5-3a65b0cc734712017-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69336-829LIDOPAC (LIDOCAINE) OINTMENT [STERLING-KNIGHT PHARMACEUTICALS, LLC]9Legacy NDC, 2 package rows20170202_b6ed830e-6548-4918-915f-c858d831e953.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LidocaineLIDOCAINEAmneal Pharmaceuticals LLC960f6d0a-82af-45e9-89d5-cea808004ebb2026-08-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206297
application number: ANDA206297
LidocaineLIDOCAINEPreferred Pharmaceuticals Inc.4806f94d-cbac-4107-b93b-8f715868ffb32026-05-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206297
application number: ANDA206297
LidocaineLIDOCAINEPHOENIX RX LLC40949067-a5a8-db8c-e063-6294a90af0fb2026-02-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206297
application number: ANDA206297
LidocaineLIDOCAINEAdvanced Rx Pharmacy of Tennessee, LLCf18b8413-8f52-a927-e053-2a95a90a402a2024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206297
application number: ANDA206297
LidocaineLIDOCAINEAdvanced Rx Pharmacy of Tennessee, LLCf93cbde5-329a-f880-e053-6294a90a1af22024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206297
application number: ANDA206297
LidocaineLIDOCAINEBryant Ranch Prepack6fe7721d-42b3-4284-936b-a448ca530c452023-09-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206297
application number: ANDA206297
LidocaineLIDOCAINEAmneal Pharmaceuticals LLCd1509740-f9f1-44e3-8fde-51d8683fcd872018-10-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206297
application number: ANDA206297

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1543069lidocaine 5 % Topical OintmentPSNb6ed830e-6548-4918-915f-c858d831e9539
1543069lidocaine 0.05 MG/MG Topical OintmentSCDb6ed830e-6548-4918-915f-c858d831e9539
1543069lidocaine 5 % Topical OintmentSYb6ed830e-6548-4918-915f-c858d831e9539

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
69336-829-016933608290135.44 g in 1 TUBE35.44 gHistorical