Lidocaine

Product NDC
61699-0201
11-digit product format
616990201
Labeler code
61699
Product ID
61699-0201_8c77a533-c7d7-43d2-802e-09a333d82a56
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LIDOCAINE HYDROCHLORIDE
Dosage form
INJECTION, SOLUTION
Route
INFILTRATION; PERINEURAL
Labeler
US MedSource, LLC
Application
ANDA080404
Marketing category
ANDA
Marketing start
2014-07-02
Marketing end
0000-00-00
Substance
LIDOCAINE HYDROCHLORIDE ANHYDROUS
Active strength
10 mg/mL
Pharmacologic classes
Amide Local Anesthetic [EPC],Amides [CS],Antiarrhythmic [EPC],Local Anesthesia [PE]
NDC exclude flag
E
Listing certified through
2017-12-31
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 productproduct61699-0201IInactivated by FDA2026-10-15
excluded packagepackage61699-020161699-0201-1IInactivated by FDA2026-10-15

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 NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage61699-0201-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage61699-0201-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage61699-0201-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage61699-0201-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage61699-0201-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage61699-0201-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage61699-0201-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage61699-0201-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage61699-0201-10efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage61699-0201-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage61699-0201-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage61699-0201-1557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage61699-0201-18af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage61699-0201-1834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage61699-0201-11332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage61699-0201-1fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage61699-0201-186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage61699-0201-1bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage61699-0201-18dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage61699-0201-1e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage61699-0201-19bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage61699-0201-1110d247fa046…a55b01930146…

Source provenance: Browse the complete Orange Book source catalog.

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 · 52 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A080404-002LIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAPApproved before 19825c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A080404-003LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONAPApproved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A080404-002LIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAPApproved before 19825d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A080404-003LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONAPApproved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A080404-002LIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAPApproved before 19824b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A080404-003LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONAPApproved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A080404-002LIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAPApproved before 198274a2ff9319b5…
2019-12-13 00:20 UTC2019-12A080404-003LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONAPApproved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A080404-002LIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAPApproved before 1982bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A080404-003LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONAPApproved before 1982bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A080404-002LIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAPApproved before 1982782e0a99824c…
2021-12-28 21:50 UTC2021-12A080404-003LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONAPApproved before 1982782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A080404-002LIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAPApproved before 198287673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A080404-003LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONAPApproved before 198287673890dc5c…
2021-03-12 10:30 UTC2021-03A080404-002LIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAPApproved before 19825aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A080404-003LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONAPApproved before 19825aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A080404-002LIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAPApproved before 19828869cabd3fbd…
2020-12-22 03:56 UTC2020-12A080404-003LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONAPApproved before 19828869cabd3fbd…
2020-11-12 02:37 UTC2020-11A080404-002LIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAPApproved before 1982c0c555d07b60…
2020-11-12 02:37 UTC2020-11A080404-003LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONAPApproved before 1982c0c555d07b60…
2019-12-14 00:12 UTC2019-12A080404-002LIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAPApproved before 19823f01610625f2…
2019-12-14 00:12 UTC2019-12A080404-003LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONAPApproved before 19823f01610625f2…
2019-09-15 20:21 UTC2019-09A080404-002LIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAPApproved before 1982b00525d2431f…
2019-09-15 20:21 UTC2019-09A080404-003LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONAPApproved before 1982b00525d2431f…
2019-07-19 19:46 UTC2019-07A080404-002LIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAPApproved before 1982ea99ee380514…
2019-07-19 19:46 UTC2019-07A080404-003LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONAPApproved before 1982ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A080404-002LIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAPApproved before 19826a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A080404-003LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONAPApproved before 19826a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A080404-002LIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAPApproved before 19821c564ffb4f44…
2024-02-18 07:12 UTC2024-02A080404-003LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONAPApproved before 19821c564ffb4f44…
2023-12-20 04:57 UTC2023-12A080404-002LIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAPApproved before 1982ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A080404-003LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONAPApproved before 1982ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A080404-002LIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAPApproved before 1982a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A080404-003LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONAPApproved before 1982a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A080404-002LIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAPApproved before 19829b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A080404-003LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONAPApproved before 19829b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A080404-002LIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAPApproved before 1982a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A080404-003LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONAPApproved before 1982a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A080404-002LIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAPApproved before 19823f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A080404-003LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONAPApproved before 19823f0d92c62455…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 52 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A080404-002AP15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A080404-003AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A080404-002AP15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A080404-003AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A080404-002AP14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A080404-003AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A080404-002AP174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A080404-003AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A080404-002AP1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A080404-003AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A080404-002AP1782e0a99824c…
2021-12-28 21:50 UTC2021-12A080404-003AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A080404-002AP187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A080404-003AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A080404-002AP15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A080404-003AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A080404-002AP18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A080404-003AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A080404-002AP1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A080404-003AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A080404-002AP13f01610625f2…
2019-12-14 00:12 UTC2019-12A080404-003AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A080404-002AP1b00525d2431f…
2019-09-15 20:21 UTC2019-09A080404-003AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A080404-002AP1ea99ee380514…
2019-07-19 19:46 UTC2019-07A080404-003AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A080404-002AP16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A080404-003AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A080404-002AP11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A080404-003AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A080404-002AP1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A080404-003AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A080404-002AP1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A080404-003AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A080404-002AP19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A080404-003AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A080404-002AP1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A080404-003AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A080404-002AP13f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A080404-003AP13f0d92c62455…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61699-0201-12019-11-27C16284748780-19855e2a2-3d5c-60a7-e053-dbdaa90a05bdLidocaine Hydrochloride Injection, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61699-0201-1Lidocaine10 mL in 1.0 VIALINJECTION, SOLUTION101
61699-0201-1Lidocaine1 in 1 BAGINJECTION, SOLUTION11

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61699-0201LIDOCAINE (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION [US MEDSOURCE, LLC]1Legacy NDC, 2 package rows20140707_2c6107e2-adf9-4096-8385-299e14e3102b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1010033lidocaine HCl 1 % Injectable SolutionPSN2c6107e2-adf9-4096-8385-299e14e3102b1
1010033lidocaine hydrochloride 10 MG/ML Injectable SolutionSCD2c6107e2-adf9-4096-8385-299e14e3102b1
1010033lidocaine hydrochloride 1 % Injectable SolutionSY2c6107e2-adf9-4096-8385-299e14e3102b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
61699-0201-16169902010110 mL in 1.0 VIAL10 mlHistorical