Lidocaine Hydrochloride

Product NDC
68999-871
11-digit product format
689990871
Labeler code
68999
Product ID
68999-871_4936e0c5-1b30-6073-e063-6394a90a4c12
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine Hydrochloride
Dosage form
SOLUTION
Route
OROPHARYNGEAL
Labeler
Chartwell Governmental & Specialty RX, LLC.
Application
ANDA040708
Marketing category
ANDA
Marketing start
2007-02-27
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
2027-12-31
Current FDA listing
Yes

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…

Additional Listing Data#

Finished product
Yes
Brand name base
Lidocaine Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE HYDROCHLORIDE ANHYDROUS20 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
EC2CNF7XFPInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1010739Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
f79b8b30-67ed-4daa-8233-ee2319592ef0Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68999-871-24Lidocaine Hydrochloride10 in 1 TRAYSOLUTION101
68999-871-24Lidocaine Hydrochloride2 in 1 BOXSOLUTION21
68999-871-51Lidocaine Hydrochloride15 mL in 1 CUPSOLUTION151

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68999-871-24ML - Milliliter68999-871977c9091-6e39-416f-8bb8-48f2159933c412026-04-20
68999-871-51ML - Milliliter68999-87100f87599-735c-471b-91c2-9d6f10e6256612026-04-20

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
ndc (product): 68999-871

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1010739lidocaine HCl 2 % Mucous Membrane Topical SolutionPSNf79b8b30-67ed-4daa-8233-ee2319592ef01
1010739lidocaine hydrochloride 20 MG/ML Mucous Membrane Topical SolutionSCDf79b8b30-67ed-4daa-8233-ee2319592ef01
1010739lidocaine HCl 2 % Oral Topical SolutionSYf79b8b30-67ed-4daa-8233-ee2319592ef01
1010739lidocaine HCl 2 % Oromucosal SolutionSYf79b8b30-67ed-4daa-8233-ee2319592ef01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68999-871-24689990871242 TRAY in 1 BOX (68999-871-24) / 10 CUP in 1 TRAY / 15 mL in 1 CUP (68999-871-51) 2 tray2026-01-21NoNoCurrent
68999-871-516899908715115 mL in 1 CUP15 mlHistorical