Lidocaine

Product NDC
31382-898
11-digit product format
313820898
Labeler code
31382
Product ID
31382-898_ac668f6a-b837-4dd7-8f5f-3363f560a6be
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine Hydrochloride and Epinephrine Bitartrate
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
CareStream Health, Inc.
Application
ANDA088390
Marketing category
ANDA
Marketing start
2011-11-07
Marketing end
0000-00-00
Substance
LIDOCAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE
Active strength
20 mg/mL; mg/mL
Pharmacologic classes
Amide Local Anesthetic [EPC],Amides [CS],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [CS]
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 productproduct31382-898DDiscontinued by firm2026-08-03
excluded packagepackage31382-89831382-898-05DDiscontinued by firm2026-08-03

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 productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage31382-898-05DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage31382-898-05DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage31382-898-05DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage31382-898-05DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage31382-898-05DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage31382-898-05DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage31382-898-05DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage31382-898-05DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage31382-898-05DDiscontinued by firm0efc9e666f02…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 packagepackage31382-898-05IInactivated 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 packagepackage31382-898-05IInactivated 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 packagepackage31382-898-05IInactivated 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 packagepackage31382-898-05IInactivated 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 packagepackage31382-898-05IInactivated 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 packagepackage31382-898-05IInactivated 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 packagepackage31382-898-05IInactivated 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 packagepackage31382-898-05IInactivated 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 packagepackage31382-898-05IInactivated 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 packagepackage31382-898-05IInactivated 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 packagepackage31382-898-05IInactivated 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 packagepackage31382-898-05IInactivated 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 packagepackage31382-898-05EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

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
A088390-001LIGNOSPAN STANDARDEPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDEEQ 0.01MG BASE/ML;2%INJECTABLE / INJECTIONRLD, RS1985-01-22

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 UTC2026-02A088390-001LIGNOSPAN STANDARDEQ 0.01MG BASE/ML;2%INJECTABLE / INJECTIONRLD, RS1985-01-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A088390-001LIGNOSPAN STANDARDEQ 0.01MG BASE/ML;2%INJECTABLE / INJECTIONRLD, RS1985-01-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A088390-001LIGNOSPAN STANDARDEQ 0.01MG BASE/ML;2%INJECTABLE / INJECTIONRLD, RS1985-01-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A088390-001LIGNOSPAN STANDARDEQ 0.01MG BASE/ML;2%INJECTABLE / INJECTIONRLD, RS1985-01-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A088390-001LIGNOSPAN STANDARDEQ 0.01MG BASE/ML;2%INJECTABLE / INJECTIONRLD, RS1985-01-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A088390-001LIGNOSPAN STANDARDEQ 0.01MG BASE/ML;2%INJECTABLE / INJECTIONRLD, RS1985-01-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A088390-001LIGNOSPAN STANDARDEQ 0.01MG BASE/ML;2%INJECTABLE / INJECTIONRLD, RS1985-01-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A088390-001LIGNOSPAN STANDARDEQ 0.01MG BASE/ML;2%INJECTABLE / INJECTIONRLD, RS1985-01-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A088390-001LIGNOSPAN STANDARDEQ 0.01MG BASE/ML;2%INJECTABLE / INJECTIONRLD, RS1985-01-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A088390-001LIGNOSPAN STANDARDEQ 0.01MG BASE/ML;2%INJECTABLE / INJECTIONRLD, RS1985-01-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A088390-001LIGNOSPAN STANDARDEQ 0.01MG BASE/ML;2%INJECTABLE / INJECTIONRLD, RS1985-01-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A088390-001LIGNOSPAN STANDARDEQ 0.01MG BASE/ML;2%INJECTABLE / INJECTIONRLD, RS1985-01-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A088390-001LIGNOSPAN STANDARDEQ 0.01MG BASE/ML;2%INJECTABLE / INJECTIONRLD, RS1985-01-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05A088390-001LIGNOSPAN STANDARDEQ 0.01MG BASE/ML;2%INJECTABLE / INJECTIONRLD, RS1985-01-228072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A088390-001LIGNOSPAN STANDARDEQ 0.01MG BASE/ML;2%INJECTABLE / INJECTIONRLD, RS1985-01-225c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A088390-001LIGNOSPAN STANDARDEQ 0.01MG BASE/ML;2%INJECTABLE / INJECTIONRLD, RS1985-01-225d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A088390-001LIGNOSPAN STANDARDEQ 0.01MG BASE/ML;2%INJECTABLE / INJECTIONRLD, RS1985-01-224b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A088390-001LIGNOSPAN STANDARDEQ 0.01MG BASE/ML;2%INJECTABLE / INJECTIONRS1985-01-2274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A088390-001LIGNOSPAN STANDARDEQ 0.01MG BASE/ML;2%INJECTABLE / INJECTIONRLD, RS1985-01-22bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A088390-001LIGNOSPAN STANDARDEQ 0.01MG BASE/ML;2%INJECTABLE / INJECTIONRS1985-01-22782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A088390-001LIGNOSPAN STANDARDEQ 0.01MG BASE/ML;2%INJECTABLE / INJECTIONRS1985-01-2287673890dc5c…
2021-03-12 10:30 UTC2021-03A088390-001LIGNOSPAN STANDARDEQ 0.01MG BASE/ML;2%INJECTABLE / INJECTIONRS1985-01-225aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A088390-001LIGNOSPAN STANDARDEQ 0.01MG BASE/ML;2%INJECTABLE / INJECTIONRS1985-01-228869cabd3fbd…
2020-11-12 02:37 UTC2020-11A088390-001LIGNOSPAN STANDARDEQ 0.01MG BASE/ML;2%INJECTABLE / INJECTIONRS1985-01-22c0c555d07b60…
2019-12-14 00:12 UTC2019-12A088390-001LIGNOSPAN STANDARDEQ 0.01MG BASE/ML;2%INJECTABLE / INJECTIONRS1985-01-223f01610625f2…
2019-09-15 20:21 UTC2019-09A088390-001LIGNOSPAN STANDARDEQ 0.01MG BASE/ML;2%INJECTABLE / INJECTIONRS1985-01-22b00525d2431f…
2019-07-19 19:46 UTC2019-07A088390-001LIGNOSPAN STANDARDEQ 0.01MG BASE/ML;2%INJECTABLE / INJECTIONRS1985-01-22ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A088390-001LIGNOSPAN STANDARDEQ 0.01MG BASE/ML;2%INJECTABLE / INJECTIONRLD, RS1985-01-226a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A088390-001LIGNOSPAN STANDARDEQ 0.01MG BASE/ML;2%INJECTABLE / INJECTIONRLD, RS1985-01-221c564ffb4f44…
2023-12-20 04:57 UTC2023-12A088390-001LIGNOSPAN STANDARDEQ 0.01MG BASE/ML;2%INJECTABLE / INJECTIONRLD, RS1985-01-22ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A088390-001LIGNOSPAN STANDARDEQ 0.01MG BASE/ML;2%INJECTABLE / INJECTIONRLD, RS1985-01-22a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A088390-001LIGNOSPAN STANDARDEQ 0.01MG BASE/ML;2%INJECTABLE / INJECTIONRLD, RS1985-01-229b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A088390-001LIGNOSPAN STANDARDEQ 0.01MG BASE/ML;2%INJECTABLE / INJECTIONRLD, RS1985-01-22a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A088390-001LIGNOSPAN STANDARDEQ 0.01MG BASE/ML;2%INJECTABLE / INJECTIONRLD, RS1985-01-223f0d92c62455…
2023-05-13 08:27 UTC2023-05A088390-001LIGNOSPAN STANDARDEQ 0.01MG BASE/ML;2%INJECTABLE / INJECTIONRLD, RS1985-01-22053a50430f4f…
2023-01-26 05:58 UTC2023-01A088390-001LIGNOSPAN STANDARDEQ 0.01MG BASE/ML;2%INJECTABLE / INJECTIONRLD, RS1985-01-223bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A088390-001LIGNOSPAN STANDARDEQ 0.01MG BASE/ML;2%INJECTABLE / INJECTIONRLD, RS1985-01-223a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A088390-001LIGNOSPAN STANDARDEQ 0.01MG BASE/ML;2%INJECTABLE / INJECTIONRLD, RS1985-01-22f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A088390-001LIGNOSPAN STANDARDEQ 0.01MG BASE/ML;2%INJECTABLE / INJECTIONRLD, RS1985-01-22e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A088390-001LIGNOSPAN STANDARDEQ 0.01MG BASE/ML;2%INJECTABLE / INJECTIONRLD, RS1985-01-22cb3db0bc1861…

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31382-898-05ML - Milliliter31382-898c2aa3de7-a44a-47a5-af47-355bc63ab33012022-04-06

DailyMed Socrata Ingredients#

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 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LidocaineLIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEBenco Dentalc5cc87df-df3f-42b8-af84-5f2045d420842026-07-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088390
application number: ANDA088390
LIDOCAINELIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEPatterson Dental6506755f-c9f7-4286-9ba7-ac5d5745f5e42026-07-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088390
application number: ANDA088390
LidocaineLIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEDarby Dental Supply, LLCe5ed4c2a-e320-48cf-a2fd-61d48481c6242026-07-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088390
application number: ANDA088390
LidocaineLIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEHenry Schein Inc.f8d90500-f797-4238-8dd2-b59cbcd89d122026-04-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088390
application number: ANDA088390
LidocaineLIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATENovocol Pharmaceutical of Canada, Inc.2005680a-8a23-4403-a618-e4ee74fa11212026-03-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088390
application number: ANDA088390
Lignospan StandardLIDOCAINE HYDROCHLORIDE AND EPINEPHRINESeptodont, Inc.f902d2b4-28fc-41b1-a9f7-0d1a63c598aa2025-03-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088390
application number: ANDA088390
LidocaineLIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATESafco Dental Supply Co6721c3ab-c37f-4504-aebc-0103c56ed5672024-02-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088390
application number: ANDA088390
LIDOCAINELIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATENDC, Inc.937e9341-e604-4ca7-98e1-fc7c659d82e92024-02-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088390
application number: ANDA088390
LidocaineLIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEThe Atlanta Dental Supply Company DBA Advanced Dental Products55030c51-250b-4fc2-ba3c-ac38dab7cc8e2024-02-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088390
application number: ANDA088390
LidocaineLIDOCAINE HYDROCHLORIDE AND EPINEPHRINESeptodont, Inc.864e511b-cc50-4ed9-b122-8e1a934573322024-02-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088390
application number: ANDA088390
XylocaineLIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEDentsply Pharmaceutical14b55cf9-f7cd-4bb4-a7c5-aba61abadef12024-02-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088390
application number: ANDA088390