FDA.reportPublic FDA data

Lidocaine Hydrochloride and Epinephrine

Product NDC
0404-9896
11-digit product format
004049896
Labeler code
0404
Product ID
0404-9896_d87f42ac-77cf-4b44-8bf8-163c89cc80da
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine Hydrochloride and Epinephrine
Dosage form
INJECTION, SOLUTION
Route
INFILTRATION; PERINEURAL
Labeler
Henry Schein, Inc.
Application
ANDA089646
Marketing category
ANDA
Marketing start
2022-01-12
Substance
EPINEPHRINE; LIDOCAINE HYDROCHLORIDE
Active strength
10; 20 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
2026-12-31
Current FDA listing
Yes

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, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
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…

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
A089646-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINEEPINEPHRINE; LIDOCAINE HYDROCHLORIDE0.01MG/ML;2%INJECTABLE / INJECTIONRS1988-06-21

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 UTC2026-02A089646-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.01MG/ML;2%INJECTABLE / INJECTIONRS1988-06-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A089646-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.01MG/ML;2%INJECTABLE / INJECTIONRS1988-06-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A089646-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.01MG/ML;2%INJECTABLE / INJECTIONRS1988-06-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A089646-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.01MG/ML;2%INJECTABLE / INJECTIONRS1988-06-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A089646-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.01MG/ML;2%INJECTABLE / INJECTIONRS1988-06-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A089646-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.01MG/ML;2%INJECTABLE / INJECTIONRS1988-06-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A089646-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.01MG/ML;2%INJECTABLE / INJECTIONRS1988-06-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A089646-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.01MG/ML;2%INJECTABLE / INJECTIONRS1988-06-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A089646-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.01MG/ML;2%INJECTABLE / INJECTIONRS1988-06-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A089646-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.01MG/ML;2%INJECTABLE / INJECTIONRS1988-06-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A089646-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.01MG/ML;2%INJECTABLE / INJECTIONRS1988-06-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A089646-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.01MG/ML;2%INJECTABLE / INJECTIONRS1988-06-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A089646-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.01MG/ML;2%INJECTABLE / INJECTIONRS1988-06-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A089646-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.01MG/ML;2%INJECTABLE / INJECTIONRS1988-06-218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A089646-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.01MG/ML;2%INJECTABLE / INJECTIONAPRS1988-06-215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A089646-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.01MG/ML;2%INJECTABLE / INJECTIONAPRS1988-06-215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A089646-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.01MG/ML;2%INJECTABLE / INJECTIONAPRS1988-06-214b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A089646-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.01MG/ML;2%INJECTABLE / INJECTIONAPRS1988-06-2174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A089646-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.01MG/ML;2%INJECTABLE / INJECTIONAPRS1988-06-21bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A089646-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.01MG/ML;2%INJECTABLE / INJECTIONAPRS1988-06-21782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A089646-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.01MG/ML;2%INJECTABLE / INJECTIONAPRS1988-06-2187673890dc5c…
2021-03-12 10:30 UTC2021-03A089646-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.01MG/ML;2%INJECTABLE / INJECTIONAPRS1988-06-215aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A089646-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.01MG/ML;2%INJECTABLE / INJECTIONAPRS1988-06-218869cabd3fbd…
2020-11-12 02:37 UTC2020-11A089646-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.01MG/ML;2%INJECTABLE / INJECTIONAPRS1988-06-21c0c555d07b60…
2019-12-14 00:12 UTC2019-12A089646-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.01MG/ML;2%INJECTABLE / INJECTIONAPRS1988-06-213f01610625f2…
2019-09-15 20:21 UTC2019-09A089646-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.01MG/ML;2%INJECTABLE / INJECTIONAPRS1988-06-21b00525d2431f…
2019-07-19 19:46 UTC2019-07A089646-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.01MG/ML;2%INJECTABLE / INJECTIONAPRS1988-06-21ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A089646-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.01MG/ML;2%INJECTABLE / INJECTIONRS1988-06-216a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A089646-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.01MG/ML;2%INJECTABLE / INJECTIONRS1988-06-211c564ffb4f44…
2023-12-20 04:57 UTC2023-12A089646-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.01MG/ML;2%INJECTABLE / INJECTIONRS1988-06-21ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A089646-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.01MG/ML;2%INJECTABLE / INJECTIONRS1988-06-21a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A089646-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.01MG/ML;2%INJECTABLE / INJECTIONRS1988-06-219b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A089646-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.01MG/ML;2%INJECTABLE / INJECTIONRS1988-06-21a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A089646-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.01MG/ML;2%INJECTABLE / INJECTIONRS1988-06-213f0d92c62455…
2023-05-13 08:27 UTC2023-05A089646-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.01MG/ML;2%INJECTABLE / INJECTIONAPRS1988-06-21053a50430f4f…
2023-01-26 05:58 UTC2023-01A089646-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.01MG/ML;2%INJECTABLE / INJECTIONAPRS1988-06-213bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A089646-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.01MG/ML;2%INJECTABLE / INJECTIONAPRS1988-06-213a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A089646-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.01MG/ML;2%INJECTABLE / INJECTIONAPRS1988-06-21f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A089646-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.01MG/ML;2%INJECTABLE / INJECTIONAPRS1988-06-21e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A089646-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.01MG/ML;2%INJECTABLE / INJECTIONAPRS1988-06-21cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A089646-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A089646-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A089646-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A089646-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A089646-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A089646-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A089646-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A089646-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A089646-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A089646-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A089646-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A089646-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A089646-001AP1ea99ee380514…
2023-05-13 08:27 UTC2023-05A089646-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A089646-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A089646-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A089646-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A089646-001AP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A089646-001AP1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Lidocaine Hydrochloride and Epinephrine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE HYDROCHLORIDE10 ug/mL
EPINEPHRINE20 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
V13007Z41AInternal UNII lookup
YKH834O4BHInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1010759Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e0e621d2-10b0-4cdf-b31d-c19b1e86ba6bAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0b4ec9ca-d305-43fc-88dd-7a510313efe0Product name120260105
bb209f42-a85f-4fee-9d3d-c9dded168625Product name120251208
49628fc7-2031-4c28-bd31-0ef3aa8f44a3Product name320251118
cbf85893-59ef-423f-87d4-a573c000a8b9Product name820250731
b5b1095b-40cd-8a9e-b111-502545045b07Product name420250325
e190029e-423b-473c-8e04-2ada59b5b711Product name120250314
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
e0031c74-3853-42bc-8e10-86dbbe83992eProduct name220231116
f7046b89-2016-499a-adc6-78479172abc6Product name120230425
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
2686d634-e712-4007-8dbf-3d37c6c4d71fProduct name120181121
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
bd49bb86-2d32-4a7a-a594-eeda2e29af42Product name120180118
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
3becbe78-12d9-4ad2-9b4c-1e36f8d1303aProduct name120170815
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0404-9896-30Lidocaine Hydrochloride and Epinephrine30 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION3012
0404-9896-30Lidocaine Hydrochloride and Epinephrine1 in 1 BAGINJECTION, SOLUTION112
0404-9896-50Lidocaine Hydrochloride and Epinephrine50 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION5012
0404-9896-50Lidocaine Hydrochloride and Epinephrine1 in 1 BAGINJECTION, SOLUTION112

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0404-9896LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION, SOLUTION [HENRY SCHEIN, INC.]10Current NDC, Legacy NDC, 4 package rows20250522_e0e621d2-10b0-4cdf-b31d-c19b1e86ba6b.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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lidocaine Hydrochloride and EpinephrineLIDOCAINE HYDROCHLORIDE AND EPINEPHRINEHospira, Inc.2f94f711-14c4-48ec-c5a3-c5ec4b8e87292026-06-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089646
application number: ANDA089646
LIDOCAINE HCl AND EPINEPHRINELIDOCAINE HCL AND EPINEPHRINEHF Acquisition Co LLC, DBA HealthFirsta09613b2-4337-5b52-e053-2995a90ab74b2026-06-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089646
application number: ANDA089646
Lidocaine Hydrochloride and EpinephrineLIDOCAINE HYDROCHLORIDE AND EPINEPHRINEProPharma Distribution43048b6b-3c83-eef4-e063-6294a90a34cb2025-12-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089646
application number: ANDA089646
Lidocaine Hydrochloride and EpinephrineLIDOCAINE HYDROCHLORIDE AND EPINEPHRINEHenry Schein, Inc.e0e621d2-10b0-4cdf-b31d-c19b1e86ba6b2025-06-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089646
application number: ANDA089646
ndc (product): 0404-9896
Lidocaine Hydrochloride and EpinephrineLIDOCAINE HYDROCHLORIDE AND EPINEPHRINEHenry Schein, Inc.5692e28d-559c-4b6a-8421-fa85d71558182025-02-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089646
application number: ANDA089646
LIDOCAINE HCl AND EPINEPHRINELIDOCAINE HCL AND EPINEPHRINEHF Acquisition Co LLC, DBA HealthFirsta098ab6c-143f-77a5-e053-2a95a90a3e0a2024-02-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089646
application number: ANDA089646

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1010759lidocaine HCl 2 % / EPINEPHrine 1:100,000 Injectable SolutionPSNe0e621d2-10b0-4cdf-b31d-c19b1e86ba6b12
1010759epinephrine 0.01 MG/ML / lidocaine hydrochloride 20 MG/ML Injectable SolutionSCDe0e621d2-10b0-4cdf-b31d-c19b1e86ba6b12
1010759epinephrine (as epinephrine bitartrate) 1:100,000 / lidocaine hydrochloride 2 % Injectable SolutionSYe0e621d2-10b0-4cdf-b31d-c19b1e86ba6b12
1010759epinephrine 1:100,000 / lidocaine hydrochloride 2 % Injectable SolutionSYe0e621d2-10b0-4cdf-b31d-c19b1e86ba6b12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0404-9896-20004049896201 VIAL, MULTI-DOSE in 1 BAG (0404-9896-20) > 20 mL in 1 VIAL, MULTI-DOSE2022-01-120000-00-00NoNoCurrent
0404-9896-30004049896301 VIAL, MULTI-DOSE in 1 BAG (0404-9896-30) / 30 mL in 1 VIAL, MULTI-DOSE2022-01-120000-00-00NoNoCurrent
0404-9896-50004049896501 VIAL, MULTI-DOSE in 1 BAG (0404-9896-50) / 50 mL in 1 VIAL, MULTI-DOSE2022-01-120000-00-00NoNoCurrent