Lidocaine Hydrochloride Monohydrate

Product NDC
69420-1230
11-digit product format
694201230
Labeler code
69420
Product ID
69420-1230_47b16c49-2a6b-481d-9c46-1ce4863769e6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine Hydrochloride Monohydrate
Dosage form
POWDER
Route
INTRADERMAL
Labeler
SA3, LLC
Application
NDA022114
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2019-01-01
Marketing end
0000-00-00
Substance
LIDOCAINE HYDROCHLORIDE
Active strength
1 mg/1
Pharmacologic classes
Amide Local Anesthetic [EPC],Amides [CS],Antiarrhythmic [EPC],Local Anesthesia [PE]
NDC exclude flag
No
Listing certified through
2021-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct69420-1230DDiscontinued by firm2026-10-05
excluded packagepackage69420-123069420-1230-1DDiscontinued by firm2026-10-05
excluded packagepackage69420-123069420-1230-2DDiscontinued by firm2026-10-05

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 · 36 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 packagepackage69420-1230-1d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage69420-1230-2d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage69420-1230-1f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage69420-1230-2f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage69420-1230-12ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage69420-1230-22ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage69420-1230-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage69420-1230-2a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage69420-1230-1cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage69420-1230-2cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage69420-1230-1cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage69420-1230-2cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage69420-1230-1302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage69420-1230-2302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage69420-1230-1ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage69420-1230-2ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage69420-1230-10efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage69420-1230-20efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage69420-1230-1ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage69420-1230-2ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage69420-1230-1367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage69420-1230-2367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage69420-1230-1557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage69420-1230-2557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N022114-001ZINGOLIDOCAINE HYDROCHLORIDE0.5MGSYSTEM / INTRADERMAL2007-08-16

Orange Book patents#

Current patent rows page 1 of 1 · 3 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N022114-00185406652029-10-22U-14382013-10-09
N022114-00193583382035-04-27U-18702016-07-06
N022114-00193706222035-09-28U-18702016-07-06

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N022114-001ZINGO0.5MGSYSTEM / INTRADERMAL2007-08-1684e616aacf4f…
2026-08-18 06:07:402026-07N022114-001ZINGO0.5MGSYSTEM / INTRADERMAL2007-08-16caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N022114-001ZINGO0.5MGSYSTEM / INTRADERMAL2007-08-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022114-001ZINGO0.5MGSYSTEM / INTRADERMAL2007-08-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08N022114-001ZINGO0.5MGSYSTEM / INTRADERMAL2007-08-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022114-001ZINGO0.5MGSYSTEM / INTRADERMAL2007-08-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022114-001ZINGO0.5MGSYSTEM / INTRADERMAL2007-08-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022114-001ZINGO0.5MGSYSTEM / INTRADERMAL2007-08-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022114-001ZINGO0.5MGSYSTEM / INTRADERMAL2007-08-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022114-001ZINGO0.5MGSYSTEM / INTRADERMAL2007-08-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022114-001ZINGO0.5MGSYSTEM / INTRADERMAL2007-08-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022114-001ZINGO0.5MGSYSTEM / INTRADERMAL2007-08-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022114-001ZINGO0.5MGSYSTEM / INTRADERMAL2007-08-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022114-001ZINGO0.5MGSYSTEM / INTRADERMAL2007-08-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022114-001ZINGO0.5MGSYSTEM / INTRADERMAL2007-08-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05N022114-001ZINGO0.5MGSYSTEM / INTRADERMAL2007-08-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022114-001ZINGO0.5MGSYSTEM / INTRADERMAL2007-08-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N022114-001ZINGO0.5MGSYSTEM / INTRADERMAL2007-08-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N022114-001ZINGO0.5MGSYSTEM / INTRADERMAL2007-08-164b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N022114-001ZINGO0.5MGSYSTEM / INTRADERMAL2007-08-1674a2ff9319b5…
2022-03-09 01:35 UTC2022-03N022114-001ZINGO0.5MGSYSTEM / INTRADERMAL2007-08-16bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N022114-001ZINGO0.5MGSYSTEM / INTRADERMAL2007-08-16782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N022114-001ZINGO0.5MGSYSTEM / INTRADERMAL2007-08-1687673890dc5c…
2021-03-12 10:30 UTC2021-03N022114-001ZINGO0.5MGSYSTEM / INTRADERMAL2007-08-165aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N022114-001ZINGO0.5MGSYSTEM / INTRADERMAL2007-08-168869cabd3fbd…
2020-11-12 02:37 UTC2020-11N022114-001ZINGO0.5MGSYSTEM / INTRADERMAL2007-08-16c0c555d07b60…
2019-12-14 00:12 UTC2019-12N022114-001ZINGO0.5MGSYSTEM / INTRADERMAL2007-08-163f01610625f2…
2019-09-15 20:21 UTC2019-09N022114-001ZINGO0.5MGSYSTEM / INTRADERMAL2007-08-16b00525d2431f…
2019-07-19 19:46 UTC2019-07N022114-001ZINGO0.5MGSYSTEM / INTRADERMAL2007-08-16ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N022114-001ZINGO0.5MGSYSTEM / INTRADERMAL2007-08-166a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N022114-001ZINGO0.5MGSYSTEM / INTRADERMAL2007-08-161c564ffb4f44…
2023-12-20 04:57 UTC2023-12N022114-001ZINGO0.5MGSYSTEM / INTRADERMAL2007-08-16ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N022114-001ZINGO0.5MGSYSTEM / INTRADERMAL2007-08-16a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N022114-001ZINGO0.5MGSYSTEM / INTRADERMAL2007-08-169b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N022114-001ZINGO0.5MGSYSTEM / INTRADERMAL2007-08-16a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N022114-001ZINGO0.5MGSYSTEM / INTRADERMAL2007-08-163f0d92c62455…
2023-05-13 08:27 UTC2023-05N022114-001ZINGO0.5MGSYSTEM / INTRADERMAL2007-08-16053a50430f4f…
2023-01-26 05:58 UTC2023-01N022114-001ZINGO0.5MGSYSTEM / INTRADERMAL2007-08-163bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N022114-001ZINGO0.5MGSYSTEM / INTRADERMAL2007-08-163a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N022114-001ZINGO0.5MGSYSTEM / INTRADERMAL2007-08-16f41ea6bd6efb…

Observed Orange Book patent history#

Patent history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N022114-00185406652029-10-22U-14382013-10-0984e616aacf4f…
2026-09-14 22:38:342026-08N022114-00193583382035-04-27U-18702016-07-0684e616aacf4f…
2026-09-14 22:38:342026-08N022114-00193706222035-09-28U-18702016-07-0684e616aacf4f…
2026-08-18 06:07:402026-07N022114-00185406652029-10-22U-14382013-10-09caaa826d4ba7…
2026-08-18 06:07:402026-07N022114-00193583382035-04-27U-18702016-07-06caaa826d4ba7…
2026-08-18 06:07:402026-07N022114-00193706222035-09-28U-18702016-07-06caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N022114-00185406652029-10-22U-14382013-10-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022114-00193583382035-04-27U-18702016-07-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022114-00193706222035-09-28U-18702016-07-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022114-00185406652029-10-22U-14382013-10-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022114-00193583382035-04-27U-18702016-07-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022114-00193706222035-09-28U-18702016-07-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08N022114-00185406652029-10-22U-14382013-10-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022114-00193583382035-04-27U-18702016-07-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022114-00193706222035-09-28U-18702016-07-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022114-00185406652029-10-22U-14382013-10-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022114-00193583382035-04-27U-18702016-07-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022114-00193706222035-09-28U-18702016-07-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022114-00185406652029-10-22U-14382013-10-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022114-00193583382035-04-27U-18702016-07-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022114-00193706222035-09-28U-18702016-07-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022114-00185406652029-10-22U-14382013-10-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022114-00193583382035-04-27U-18702016-07-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022114-00193706222035-09-28U-18702016-07-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022114-00185406652029-10-22U-14382013-10-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022114-00193583382035-04-27U-18702016-07-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022114-00193706222035-09-28U-18702016-07-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022114-00185406652029-10-22U-14382013-10-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022114-00193583382035-04-27U-18702016-07-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022114-00193706222035-09-28U-18702016-07-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022114-00185406652029-10-22U-14382013-10-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022114-00193583382035-04-27U-18702016-07-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022114-00193706222035-09-28U-18702016-07-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022114-00185406652029-10-22U-14382013-10-09d06236e962d9…
2024-10-29 15:01 UTC2024-10N022114-00193583382035-04-27U-18702016-07-06d06236e962d9…
2024-10-29 15:01 UTC2024-10N022114-00193706222035-09-28U-18702016-07-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022114-00185406652029-10-22U-14382013-10-0979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022114-00193583382035-04-27U-18702016-07-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022114-00193706222035-09-28U-18702016-07-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022114-00185406652029-10-22U-14382013-10-09301d65b070ca…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
69420-1230-12022-02-14These highlights do not include all the information needed to use Lidocaine Hydrochloride Monohydrate powder intradermal injection system safely and effectively. See full prescribing information for Lidocaine Hydrochloride Monohydrate powder intradermal injection system. Lidocaine Hydrochloride Monohydrate 0.5mg powder intradermal injection system Initial U.S. Approval: 1948
69420-1230-22022-02-14These highlights do not include all the information needed to use Lidocaine Hydrochloride Monohydrate powder intradermal injection system safely and effectively. See full prescribing information for Lidocaine Hydrochloride Monohydrate powder intradermal injection system. Lidocaine Hydrochloride Monohydrate 0.5mg powder intradermal injection system Initial U.S. Approval: 1948
69420-1230-12022-01-28These highlights do not include all the information needed to use Lidocaine Hydrochloride Monohydrate powder intradermal injection system safely and effectively. See full prescribing information for Lidocaine Hydrochloride Monohydrate powder intradermal injection system. Lidocaine Hydrochloride Monohydrate 0.5mg powder intradermal injection system Initial U.S. Approval: 1948
69420-1230-22022-01-28These highlights do not include all the information needed to use Lidocaine Hydrochloride Monohydrate powder intradermal injection system safely and effectively. See full prescribing information for Lidocaine Hydrochloride Monohydrate powder intradermal injection system. Lidocaine Hydrochloride Monohydrate 0.5mg powder intradermal injection system Initial U.S. Approval: 1948

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69420-1230-1EA - Each69420-1230427fdee6-b85f-4ca5-9116-f8a0ba8b7c2112019-02-13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69420-1230-1694201230011 POWDER in 1 POUCH (69420-1230-1) 1 powder2019-01-010000-00-00NoNoCurrent
69420-1230-26942012300212 POUCH in 1 CARTON (69420-1230-2) > 1 POWDER in 1 POUCH12 pouch2019-01-010000-00-00NoNoCurrent