Lidocaine Hydrochloride

Product NDC
63629-2095
11-digit product format
636292095
Labeler code
63629
Product ID
63629-2095_49ad6ae8-ad8b-4dd5-ad53-493954207ef7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine Hydrochloride
Dosage form
SOLUTION
Route
OROPHARYNGEAL
Labeler
Bryant Ranch Prepack
Application
ANDA040708
Marketing category
ANDA
Marketing start
2007-02-27
Marketing end
0000-00-00
Substance
LIDOCAINE HYDROCHLORIDE ANHYDROUS
Active strength
20 mg/mL
Pharmacologic classes
Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
NDC exclude flag
No
Listing certified through
2023-12-31
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 productproduct63629-2095DDiscontinued by firm2026-08-10
excluded packagepackage63629-209563629-2095-1DDiscontinued by firm2026-08-10

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 · 4 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 packagepackage63629-2095-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-2095-1f5e01cc5f278…a2eaf40c39c3…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A040708-001LIDOCAINE HYDROCHLORIDE VISCOUSLIDOCAINE HYDROCHLORIDE2%SOLUTION / ORALAT2007-02-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A040708-001AT

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A040708-001LIDOCAINE HYDROCHLORIDE VISCOUS2%SOLUTION / ORALAT2007-02-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040708-001LIDOCAINE HYDROCHLORIDE VISCOUS2%SOLUTION / ORALAT2007-02-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A040708-001LIDOCAINE HYDROCHLORIDE VISCOUS2%SOLUTION / ORALAT2007-02-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040708-001LIDOCAINE HYDROCHLORIDE VISCOUS2%SOLUTION / ORALAT2007-02-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040708-001LIDOCAINE HYDROCHLORIDE VISCOUS2%SOLUTION / ORALAT2007-02-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040708-001LIDOCAINE HYDROCHLORIDE VISCOUS2%SOLUTION / ORALAT2007-02-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040708-001LIDOCAINE HYDROCHLORIDE VISCOUS2%SOLUTION / ORALAT2007-02-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040708-001LIDOCAINE HYDROCHLORIDE VISCOUS2%SOLUTION / ORALAT2007-02-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040708-001LIDOCAINE HYDROCHLORIDE VISCOUS2%SOLUTION / ORALAT2007-02-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040708-001LIDOCAINE HYDROCHLORIDE VISCOUS2%SOLUTION / ORALAT2007-02-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040708-001LIDOCAINE HYDROCHLORIDE VISCOUS2%SOLUTION / ORALAT2007-02-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040708-001LIDOCAINE HYDROCHLORIDE VISCOUS2%SOLUTION / ORALAT2007-02-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040708-001LIDOCAINE HYDROCHLORIDE VISCOUS2%SOLUTION / ORALAT2007-02-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040708-001LIDOCAINE HYDROCHLORIDE VISCOUS2%SOLUTION / ORALAT2007-02-278072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040708-001LIDOCAINE HYDROCHLORIDE VISCOUS2%SOLUTION / ORALAT2007-02-275c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040708-001LIDOCAINE HYDROCHLORIDE VISCOUS2%SOLUTION / ORALAT2007-02-275d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040708-001LIDOCAINE HYDROCHLORIDE VISCOUS2%SOLUTION / ORALAT2007-02-274b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040708-001LIDOCAINE HYDROCHLORIDE VISCOUS2%SOLUTION / ORALATRS2007-02-2774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040708-001LIDOCAINE HYDROCHLORIDE VISCOUS2%SOLUTION / ORALAT2007-02-27bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040708-001LIDOCAINE HYDROCHLORIDE VISCOUS2%SOLUTION / ORALAT2007-02-27782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040708-001LIDOCAINE HYDROCHLORIDE VISCOUS2%SOLUTION / ORALAT2007-02-2787673890dc5c…
2021-03-12 10:30 UTC2021-03A040708-001LIDOCAINE HYDROCHLORIDE VISCOUS2%SOLUTION / ORALAT2007-02-275aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040708-001LIDOCAINE HYDROCHLORIDE VISCOUS2%SOLUTION / ORAL2007-02-278869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040708-001LIDOCAINE HYDROCHLORIDE VISCOUS2%SOLUTION / ORAL2007-02-27c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040708-001LIDOCAINE HYDROCHLORIDE VISCOUS2%SOLUTION / ORALATRS2007-02-273f01610625f2…
2019-09-15 20:21 UTC2019-09A040708-001LIDOCAINE HYDROCHLORIDE VISCOUS2%SOLUTION / ORALATRS2007-02-27b00525d2431f…
2019-07-19 19:46 UTC2019-07A040708-001LIDOCAINE HYDROCHLORIDE VISCOUS2%SOLUTION / ORALATRS2007-02-27ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040708-001LIDOCAINE HYDROCHLORIDE VISCOUS2%SOLUTION / ORALAT2007-02-276a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040708-001LIDOCAINE HYDROCHLORIDE VISCOUS2%SOLUTION / ORALAT2007-02-271c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040708-001LIDOCAINE HYDROCHLORIDE VISCOUS2%SOLUTION / ORALAT2007-02-27ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040708-001LIDOCAINE HYDROCHLORIDE VISCOUS2%SOLUTION / ORALAT2007-02-27a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040708-001LIDOCAINE HYDROCHLORIDE VISCOUS2%SOLUTION / ORALAT2007-02-279b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040708-001LIDOCAINE HYDROCHLORIDE VISCOUS2%SOLUTION / ORALAT2007-02-27a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040708-001LIDOCAINE HYDROCHLORIDE VISCOUS2%SOLUTION / ORALAT2007-02-273f0d92c62455…
2023-05-13 08:27 UTC2023-05A040708-001LIDOCAINE HYDROCHLORIDE VISCOUS2%SOLUTION / ORALAT2007-02-27053a50430f4f…
2023-01-26 05:58 UTC2023-01A040708-001LIDOCAINE HYDROCHLORIDE VISCOUS2%SOLUTION / ORALAT2007-02-273bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040708-001LIDOCAINE HYDROCHLORIDE VISCOUS2%SOLUTION / ORALAT2007-02-273a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040708-001LIDOCAINE HYDROCHLORIDE VISCOUS2%SOLUTION / ORALAT2007-02-27f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040708-001LIDOCAINE HYDROCHLORIDE VISCOUS2%SOLUTION / ORALAT2007-02-27e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040708-001LIDOCAINE HYDROCHLORIDE VISCOUS2%SOLUTION / ORALAT2007-02-27cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A040708-001AT1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040708-001AT131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040708-001AT16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040708-001AT1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040708-001AT1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040708-001AT103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040708-001AT12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040708-001AT15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040708-001AT1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040708-001AT1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040708-001AT179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040708-001AT1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040708-001AT11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040708-001AT18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040708-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040708-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040708-001AT14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040708-001AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040708-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040708-001AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040708-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03A040708-001AT15aa47cf7b7d7…
2019-12-14 00:12 UTC2019-12A040708-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09A040708-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07A040708-001AT1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040708-001AT16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040708-001AT11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040708-001AT1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040708-001AT1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040708-001AT19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040708-001AT1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040708-001AT13f0d92c62455…
2023-05-13 08:27 UTC2023-05A040708-001AT1053a50430f4f…
2023-01-26 05:58 UTC2023-01A040708-001AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040708-001AT13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040708-001AT1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040708-001AT1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040708-001AT1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A040708-001AT1a50c72e98297…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-2095-1ML - Milliliter63629-20955b34d0d7-7c0a-4ebe-ba0e-9206bb84f4df12021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-2095LIDOCAINE HYDROCHLORIDE SOLUTION [BRYANT RANCH PREPACK]102Legacy NDC20230126_92afd49e-ecf8-4644-9b4c-26e4c5fe1f9d.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEChartwell RX, LLCc05f49a2-7512-48e7-9730-f8ee05519b9d2026-01-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040708
application number: ANDA040708
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEChartwell Governmental & Specialty RX, LLC.f79b8b30-67ed-4daa-8233-ee2319592ef02026-01-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040708
application number: ANDA040708

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-2095-163629209501100 mL in 1 BOTTLE (63629-2095-1) 100 ml2021-02-160000-00-00NoNoCurrent