LIDOCAINE HCI

Product NDC
51662-1232
Requested package NDC
51662-1232-3
11-digit product format
516621232
Labeler code
51662
Product ID
51662-1232_100c9906-67c9-0450-e063-6294a90a05bb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LIDOCAINE HCI
Dosage form
INJECTION, SOLUTION
Route
INFILTRATION; PERINEURAL
Labeler
HF Acquisition Co LLC, DBA HealthFirst
Application
ANDA089644
Marketing category
ANDA
Marketing start
2018-09-17
Substance
EPINEPHRINE; LIDOCAINE HYDROCHLORIDE
Active strength
10; 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
2026-12-31
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
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…

Additional Listing Data#

Finished product
Yes
Brand name base
LIDOCAINE HCI
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE HYDROCHLORIDE10 ug/mL
EPINEPHRINE10 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
1010751Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
76176d50-a987-c9f9-e053-2991aa0aea0fAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
0b4ec9ca-d305-43fc-88dd-7a510313efe0Product name120260105
bb209f42-a85f-4fee-9d3d-c9dded168625Product name120251208
49628fc7-2031-4c28-bd31-0ef3aa8f44a3Product name320251118
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
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
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
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
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51662-1232-1LIDOCAINE HCI20 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION208
51662-1232-2LIDOCAINE HCI1 mL in 1 POUCHINJECTION, SOLUTION18
51662-1232-3LIDOCAINE HCI1 in 1 CASEINJECTION, SOLUTION18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51662-1232LIDOCAINE HCI INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST]8Current NDC, Legacy NDC, 3 package rows20240130_76176d50-a987-c9f9-e053-2991aa0aea0f.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 · 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
ndc (package): 51662-1232-3
ndc (product): 51662-1232
ndc11 (package): 51662123203
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1010751lidocaine HCl 1 % / EPINEPHrine 1:100,000 Injectable SolutionPSN76176d50-a987-c9f9-e053-2991aa0aea0f8
1010751epinephrine 0.01 MG/ML / lidocaine hydrochloride 10 MG/ML Injectable SolutionSCD76176d50-a987-c9f9-e053-2991aa0aea0f8
1010751epinephrine (as epinephrine bitartrate) 1:100,000 / lidocaine hydrochloride 1 % Injectable SolutionSY76176d50-a987-c9f9-e053-2991aa0aea0f8
1010751lidocaine HCl 1 % / EPINEPHrine 1:100,000 Injectable SolutionSY76176d50-a987-c9f9-e053-2991aa0aea0f8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51662-1232-3516621232031 POUCH in 1 CASE (51662-1232-3) / 1 mL in 1 POUCH (51662-1232-2) 1 pouch2020-09-210000-00-00NoNoCurrent