Lidocaine Hydrochloride and Epinephrine

Product NDC
52584-178
Requested package NDC
52584-178-01
11-digit product format
525840178
Labeler code
52584
Product ID
52584-178_3379b75d-f566-41dd-8458-e6c9e6853eb8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine Hydrochloride and Epinephrine
Dosage form
INJECTION, SOLUTION
Route
INFILTRATION
Labeler
General Injectables & Vaccines, Inc
Application
ANDA089644
Marketing category
ANDA
Marketing start
2010-08-01
Marketing end
2023-06-01
Substance
EPINEPHRINE; LIDOCAINE HYDROCHLORIDE
Active strength
10 ug/mL; mg/mL
Pharmacologic classes
Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Catecholamine [EPC], Catecholamines [CS], Local Anesthesia [PE], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
0000-00-00
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage52584-17852584-178-01DDiscontinued 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 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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
A089644-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINEEPINEPHRINE; LIDOCAINE HYDROCHLORIDE0.01MG/ML;1%INJECTABLE / INJECTIONAP1988-06-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A089644-001AP

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 UTC2026-02A089644-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.01MG/ML;1%INJECTABLE / INJECTIONAP1988-06-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A089644-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.01MG/ML;1%INJECTABLE / INJECTIONAP1988-06-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A089644-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.01MG/ML;1%INJECTABLE / INJECTIONAP1988-06-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A089644-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.01MG/ML;1%INJECTABLE / INJECTIONAP1988-06-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A089644-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.01MG/ML;1%INJECTABLE / INJECTIONAP1988-06-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A089644-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.01MG/ML;1%INJECTABLE / INJECTIONAP1988-06-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A089644-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.01MG/ML;1%INJECTABLE / INJECTIONAP1988-06-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A089644-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.01MG/ML;1%INJECTABLE / INJECTIONAP1988-06-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A089644-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.01MG/ML;1%INJECTABLE / INJECTIONAP1988-06-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A089644-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.01MG/ML;1%INJECTABLE / INJECTIONAP1988-06-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A089644-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.01MG/ML;1%INJECTABLE / INJECTIONAP1988-06-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A089644-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.01MG/ML;1%INJECTABLE / INJECTIONAP1988-06-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A089644-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.01MG/ML;1%INJECTABLE / INJECTIONAP1988-06-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A089644-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.01MG/ML;1%INJECTABLE / INJECTIONAP1988-06-218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A089644-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.01MG/ML;1%INJECTABLE / INJECTIONAP1988-06-215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A089644-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.01MG/ML;1%INJECTABLE / INJECTIONAP1988-06-215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A089644-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.01MG/ML;1%INJECTABLE / INJECTIONAP1988-06-214b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A089644-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.01MG/ML;1%INJECTABLE / INJECTIONAP1988-06-2174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A089644-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.01MG/ML;1%INJECTABLE / INJECTIONAP1988-06-21bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A089644-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.01MG/ML;1%INJECTABLE / INJECTIONAP1988-06-21782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A089644-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.01MG/ML;1%INJECTABLE / INJECTIONAP1988-06-2187673890dc5c…
2021-03-12 10:30 UTC2021-03A089644-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.01MG/ML;1%INJECTABLE / INJECTIONAP1988-06-215aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A089644-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.01MG/ML;1%INJECTABLE / INJECTIONAP1988-06-218869cabd3fbd…
2020-11-12 02:37 UTC2020-11A089644-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.01MG/ML;1%INJECTABLE / INJECTIONAP1988-06-21c0c555d07b60…
2019-12-14 00:12 UTC2019-12A089644-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.01MG/ML;1%INJECTABLE / INJECTIONAP1988-06-213f01610625f2…
2019-09-15 20:21 UTC2019-09A089644-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.01MG/ML;1%INJECTABLE / INJECTIONAP1988-06-21b00525d2431f…
2019-07-19 19:46 UTC2019-07A089644-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.01MG/ML;1%INJECTABLE / INJECTIONAP1988-06-21ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A089644-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.01MG/ML;1%INJECTABLE / INJECTIONAP1988-06-216a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A089644-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.01MG/ML;1%INJECTABLE / INJECTIONAP1988-06-211c564ffb4f44…
2023-12-20 04:57 UTC2023-12A089644-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.01MG/ML;1%INJECTABLE / INJECTIONAP1988-06-21ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A089644-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.01MG/ML;1%INJECTABLE / INJECTIONAP1988-06-21a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A089644-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.01MG/ML;1%INJECTABLE / INJECTIONAP1988-06-219b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A089644-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.01MG/ML;1%INJECTABLE / INJECTIONAP1988-06-21a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A089644-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.01MG/ML;1%INJECTABLE / INJECTIONAP1988-06-213f0d92c62455…
2023-05-13 08:27 UTC2023-05A089644-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.01MG/ML;1%INJECTABLE / INJECTIONAP1988-06-21053a50430f4f…
2023-01-26 05:58 UTC2023-01A089644-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.01MG/ML;1%INJECTABLE / INJECTIONAP1988-06-213bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A089644-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.01MG/ML;1%INJECTABLE / INJECTIONAP1988-06-213a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A089644-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.01MG/ML;1%INJECTABLE / INJECTIONAP1988-06-21f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A089644-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.01MG/ML;1%INJECTABLE / INJECTIONAP1988-06-21e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A089644-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.01MG/ML;1%INJECTABLE / INJECTIONAP1988-06-21cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A089644-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A089644-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A089644-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A089644-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A089644-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A089644-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A089644-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A089644-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A089644-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A089644-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A089644-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A089644-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A089644-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A089644-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A089644-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A089644-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A089644-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A089644-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A089644-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A089644-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A089644-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A089644-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A089644-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A089644-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A089644-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A089644-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A089644-001AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A089644-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A089644-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A089644-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A089644-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A089644-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A089644-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A089644-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A089644-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A089644-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A089644-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A089644-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A089644-001AP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A089644-001AP1cb3db0bc1861…

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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LIDOCAINE HCILIDOCAINE HCIHF Acquisition Co LLC, DBA HealthFirst76176d50-a987-c9f9-e053-2991aa0aea0f2026-06-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089644
application number: ANDA089644
Lidocaine Hydrochloride and EpinephrineLIDOCAINE HYDROCHLORIDE AND EPINEPHRINEHospira, Inc.2f94f711-14c4-48ec-c5a3-c5ec4b8e87292026-06-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089644
application number: ANDA089644
Lidocaine Hydrochloride and EpinephrineLIDOCAINE HYDROCHLORIDE AND EPINEPHRINEHenry Schein, Inc.27194739-3382-46b0-94cd-0965313453252026-06-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089644
application number: ANDA089644
Lidocaine Hydrochloride and EpinephrineLIDOCAINE HYDROCHLORIDE AND EPINEPHRINECardinal Health 107, LLC77fd6ee4-108f-4525-8df5-7db9236042ee2026-05-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089644
application number: ANDA089644
Lidocaine Hydrochloride and EpinephrineLIDOCAINE HYDROCHLORIDE AND EPINEPHRINESportpharm LLC2c58deba-dbb2-4e73-a173-36053536f03e2026-04-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089644
application number: ANDA089644
Lidocaine Hydrochloride and EpinephrineLIDOCAINE HYDROCHLORIDE AND EPINEPHRINEHenry Schein, Inc.c3490a23-14c4-43f7-b066-96a4c4298fde2026-04-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089644
application number: ANDA089644
LIDOCAINE HCILIDOCAINE HCIHF Acquisition Co LLC, DBA HealthFirst95309440-34ec-11fe-e053-2a95a90a1c902025-06-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089644
application number: ANDA089644
LIDOCAINE HCI AND EPINEPHRINELIDOCAINE HCI AND EPINEPHRINEHF Acquisition Co LLC, DBA HealthFirst957506a5-1b09-0736-e053-2995a90a0b632024-02-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089644
application number: ANDA089644

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
52584-178-01525840178011 VIAL, MULTI-DOSE in 1 BAG (52584-178-01) > 20 mL in 1 VIAL, MULTI-DOSE2010-08-012023-05-01NoNoCurrent