LIDOCAINE HCl AND EPI

Product NDC
51662-1589
11-digit product format
516621589
Labeler code
51662
Product ID
51662-1589_e52110a0-d181-53a1-e053-2995a90ae9b1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LIDOCAINE HCl AND EPI
Dosage form
INJECTION, SOLUTION
Route
INFILTRATION; PERINEURAL
Labeler
HF Acquisition Co LLC, DBA HealthFirst
Application
NDA006488
Marketing category
NDA
Marketing start
2022-07-31
Marketing end
0000-00-00
Substance
EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE ANHYDROUS
Active strength
0 mg/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
2023-12-31
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 productproduct51662-1589IInactivated by FDA2026-08-03
excluded packagepackage51662-158951662-1589-3IInactivated by FDA2026-08-03

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 · 30 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 productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage51662-1589-3IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage51662-1589-3IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage51662-1589-3IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage51662-1589-3IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage51662-1589-3IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage51662-1589-3IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductEExcluded after deficient or non-compliant submission was not corrected302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage51662-1589-3EExcluded after deficient or non-compliant submission was not corrected302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductEExcluded after deficient or non-compliant submission was not correcteded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage51662-1589-3EExcluded after deficient or non-compliant submission was not correcteded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductEExcluded after deficient or non-compliant submission was not corrected0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage51662-1589-3EExcluded after deficient or non-compliant submission was not corrected0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductEExcluded after deficient or non-compliant submission was not correctedad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage51662-1589-3EExcluded after deficient or non-compliant submission was not correctedad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductEExcluded after deficient or non-compliant submission was not corrected367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage51662-1589-3EExcluded after deficient or non-compliant submission was not corrected367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductEExcluded after deficient or non-compliant submission was not corrected557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage51662-1589-3EExcluded after deficient or non-compliant submission was not corrected557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductEExcluded after deficient or non-compliant submission was not corrected8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage51662-1589-3EExcluded after deficient or non-compliant submission was not corrected8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductEExcluded after deficient or non-compliant submission was not corrected834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage51662-1589-3EExcluded after deficient or non-compliant submission was not corrected834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductEExcluded after deficient or non-compliant submission was not corrected1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage51662-1589-3EExcluded after deficient or non-compliant submission was not corrected1332a3947898…d4bfe170f9cd…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 11 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N006488-002XYLOCAINELIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONAPRLD, RS, Approved before 1982
N006488-003XYLOCAINE W/ EPINEPHRINEEPINEPHRINE; LIDOCAINE HYDROCHLORIDE0.01MG/ML;2%INJECTABLE / INJECTIONRLD, Approved before 1982
N006488-004XYLOCAINE W/ EPINEPHRINEEPINEPHRINE; LIDOCAINE HYDROCHLORIDE0.01MG/ML;1%INJECTABLE / INJECTIONAPRLD, RS, Approved before 1982
N006488-005XYLOCAINE W/ EPINEPHRINEEPINEPHRINE; LIDOCAINE HYDROCHLORIDE0.02MG/ML;2%INJECTABLE / INJECTIONRLD, RS, Approved before 1982
N006488-007XYLOCAINELIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAPRLD, RS, Approved before 1982
N006488-008XYLOCAINELIDOCAINE HYDROCHLORIDE0.5%INJECTABLE / INJECTIONAPRLD, RS, Approved before 1982
N006488-010XYLOCAINELIDOCAINE HYDROCHLORIDE1.5%INJECTABLE / INJECTIONAPRLD, RS, Approved before 1982
N006488-012XYLOCAINE W/ EPINEPHRINEEPINEPHRINE; LIDOCAINE HYDROCHLORIDE0.005MG/ML;0.5%INJECTABLE / INJECTIONAPRLD, RS, Approved before 1982
N006488-017XYLOCAINE W/ EPINEPHRINEEPINEPHRINE; LIDOCAINE HYDROCHLORIDE0.005MG/ML;1.5%INJECTABLE / INJECTIONAPRLD, RS, Approved before 1982
N006488-018XYLOCAINE W/ EPINEPHRINEEPINEPHRINE; LIDOCAINE HYDROCHLORIDE0.005MG/ML;1%INJECTABLE / INJECTIONRLD, RS1986-11-13
N006488-019XYLOCAINE W/ EPINEPHRINEEPINEPHRINE; LIDOCAINE HYDROCHLORIDE0.005MG/ML;2%INJECTABLE / INJECTIONAPRLD, RS1986-11-13

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 8 matching rows.

Application-product, TE code table
Application-productTE code
N006488-002AP
N006488-004AP
N006488-007AP
N006488-008AP
N006488-010AP
N006488-012AP
N006488-017AP
N006488-019AP

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 12 · 451 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N006488-002XYLOCAINE2%INJECTABLE / INJECTIONAPRLD, RS, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N006488-003XYLOCAINE W/ EPINEPHRINE0.01MG/ML;2%INJECTABLE / INJECTIONRLD, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N006488-004XYLOCAINE W/ EPINEPHRINE0.01MG/ML;1%INJECTABLE / INJECTIONAPRLD, RS, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N006488-005XYLOCAINE W/ EPINEPHRINE0.02MG/ML;2%INJECTABLE / INJECTIONRLD, RS, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N006488-007XYLOCAINE1%INJECTABLE / INJECTIONAPRLD, RS, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N006488-008XYLOCAINE0.5%INJECTABLE / INJECTIONAPRLD, RS, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N006488-010XYLOCAINE1.5%INJECTABLE / INJECTIONAPRLD, RS, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N006488-012XYLOCAINE W/ EPINEPHRINE0.005MG/ML;0.5%INJECTABLE / INJECTIONAPRLD, RS, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N006488-017XYLOCAINE W/ EPINEPHRINE0.005MG/ML;1.5%INJECTABLE / INJECTIONAPRLD, RS, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N006488-018XYLOCAINE W/ EPINEPHRINE0.005MG/ML;1%INJECTABLE / INJECTIONRLD, RS1986-11-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02N006488-019XYLOCAINE W/ EPINEPHRINE0.005MG/ML;2%INJECTABLE / INJECTIONAPRLD, RS1986-11-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N006488-002XYLOCAINE2%INJECTABLE / INJECTIONAPRLD, RS, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N006488-003XYLOCAINE W/ EPINEPHRINE0.01MG/ML;2%INJECTABLE / INJECTIONRLD, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N006488-004XYLOCAINE W/ EPINEPHRINE0.01MG/ML;1%INJECTABLE / INJECTIONAPRLD, RS, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N006488-005XYLOCAINE W/ EPINEPHRINE0.02MG/ML;2%INJECTABLE / INJECTIONRLD, RS, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N006488-007XYLOCAINE1%INJECTABLE / INJECTIONAPRLD, RS, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N006488-008XYLOCAINE0.5%INJECTABLE / INJECTIONAPRLD, RS, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N006488-010XYLOCAINE1.5%INJECTABLE / INJECTIONAPRLD, RS, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N006488-012XYLOCAINE W/ EPINEPHRINE0.005MG/ML;0.5%INJECTABLE / INJECTIONAPRLD, RS, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N006488-017XYLOCAINE W/ EPINEPHRINE0.005MG/ML;1.5%INJECTABLE / INJECTIONAPRLD, RS, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N006488-018XYLOCAINE W/ EPINEPHRINE0.005MG/ML;1%INJECTABLE / INJECTIONRLD, RS1986-11-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N006488-019XYLOCAINE W/ EPINEPHRINE0.005MG/ML;2%INJECTABLE / INJECTIONAPRLD, RS1986-11-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08N006488-002XYLOCAINE2%INJECTABLE / INJECTIONAPRLD, RS, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N006488-003XYLOCAINE W/ EPINEPHRINE0.01MG/ML;2%INJECTABLE / INJECTIONRLD, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N006488-004XYLOCAINE W/ EPINEPHRINE0.01MG/ML;1%INJECTABLE / INJECTIONAPRLD, RS, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N006488-005XYLOCAINE W/ EPINEPHRINE0.02MG/ML;2%INJECTABLE / INJECTIONRLD, RS, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N006488-007XYLOCAINE1%INJECTABLE / INJECTIONAPRLD, RS, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N006488-008XYLOCAINE0.5%INJECTABLE / INJECTIONAPRLD, RS, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N006488-010XYLOCAINE1.5%INJECTABLE / INJECTIONAPRLD, RS, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N006488-012XYLOCAINE W/ EPINEPHRINE0.005MG/ML;0.5%INJECTABLE / INJECTIONAPRLD, RS, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N006488-017XYLOCAINE W/ EPINEPHRINE0.005MG/ML;1.5%INJECTABLE / INJECTIONAPRLD, RS, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N006488-018XYLOCAINE W/ EPINEPHRINE0.005MG/ML;1%INJECTABLE / INJECTIONRLD, RS1986-11-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08N006488-019XYLOCAINE W/ EPINEPHRINE0.005MG/ML;2%INJECTABLE / INJECTIONAPRLD, RS1986-11-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N006488-002XYLOCAINE2%INJECTABLE / INJECTIONAPRLD, RS, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N006488-003XYLOCAINE W/ EPINEPHRINE0.01MG/ML;2%INJECTABLE / INJECTIONRLD, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N006488-004XYLOCAINE W/ EPINEPHRINE0.01MG/ML;1%INJECTABLE / INJECTIONAPRLD, RS, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N006488-005XYLOCAINE W/ EPINEPHRINE0.02MG/ML;2%INJECTABLE / INJECTIONRLD, RS, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N006488-007XYLOCAINE1%INJECTABLE / INJECTIONAPRLD, RS, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N006488-008XYLOCAINE0.5%INJECTABLE / INJECTIONAPRLD, RS, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N006488-010XYLOCAINE1.5%INJECTABLE / INJECTIONAPRLD, RS, Approved before 1982fd3edfee7708…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 9 · 347 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N006488-002AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N006488-004AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N006488-007AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N006488-008AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N006488-010AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N006488-012AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N006488-017AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N006488-019AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N006488-002AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N006488-004AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N006488-007AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N006488-008AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N006488-010AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N006488-012AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N006488-017AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N006488-019AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08N006488-002AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N006488-004AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N006488-007AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N006488-008AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N006488-010AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N006488-012AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N006488-017AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N006488-019AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N006488-002AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N006488-004AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N006488-007AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N006488-008AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N006488-010AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N006488-012AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N006488-017AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N006488-019AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N006488-002AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N006488-004AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N006488-007AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N006488-008AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N006488-010AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N006488-012AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N006488-017AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N006488-019AP1b8a1b40f171c…

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
51662-1589-2LIDOCAINE HCl AND EPI50 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION501
51662-1589-2LIDOCAINE HCl AND EPI1 in 1 POUCHINJECTION, SOLUTION11
51662-1589-3LIDOCAINE HCl AND EPI25 in 1 CASEINJECTION, SOLUTION251

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51662-1589LIDOCAINE HCL AND EPI INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST]1Legacy NDC, 3 package rows20220802_e52110a0-d180-53a1-e053-2995a90ae9b1.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 2 · 30 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Xylocaine MPFLIDOCAINE HYDROCHLORIDESportpharm LLC50aa6133-0776-4714-9821-fe8581f635ca2026-07-28Warnings, Adverse reactionsExact identifier
application applno (NDA): 006488
application number: NDA006488
XYLOCAINE-MPF WITH EPIXYLOCAINE-MPF WITH EPIHF Acquisition Co LLC, DBA HealthFirstc5dcb0e5-2624-9c9c-e053-2995a90a6d652026-06-19Warnings, Adverse reactionsExact identifier
application applno (NDA): 006488
application number: NDA006488
XylocaineLIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATESportpharm LLC74bad838-2800-4d36-a3ee-cc1d739d24c22026-03-21Warnings, Adverse reactionsExact identifier
application applno (NDA): 006488
application number: NDA006488
XylocaineLIDOCAINE HYDROCHLORIDESportpharm LLC94155012-b1fc-430a-a1f5-30c21f4a3f802026-02-03Warnings, Adverse reactionsExact identifier
application applno (NDA): 006488
application number: NDA006488
XylocaineLIDOCAINE HYDROCHLORIDE AND EPINEPHRINEHenry Schein, Inc.27c2e78d-d037-470d-b4fa-44c33d78f7882025-11-07Warnings, Adverse reactionsExact identifier
application applno (NDA): 006488
application number: NDA006488
XylocaineLIDOCAINE HYDROCHLORIDE AND EPINEPHRINEHenry Schein, Inc.6899113c-dee4-4227-9f68-475fcce6b91e2025-11-07Warnings, Adverse reactionsExact identifier
application applno (NDA): 006488
application number: NDA006488
XylocaineLIDOCAINE HYDROCHLORIDE AND EPINEPHRINEHenry Schein, Inc.cfcc8a07-b40c-476d-9a21-83487318ac852025-11-07Warnings, Adverse reactionsExact identifier
application applno (NDA): 006488
application number: NDA006488
XylocaineLIDOCAINE HYDROCHLORIDEHenry Schein, Inc.ffc87dfb-0e26-4b42-80fd-3fb7690119e32025-11-07Warnings, Adverse reactionsExact identifier
application applno (NDA): 006488
application number: NDA006488
XylocaineLIDOCAINE HCLHenry Schein, Inc.a6019956-a6e0-4988-a870-6aee06c354c32025-11-07Warnings, Adverse reactionsExact identifier
application applno (NDA): 006488
application number: NDA006488
XylocaineLIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATEREMEDYREPACK INC.1414bcfc-1543-4ad4-83bd-4fc444a02e922025-10-09Warnings, Adverse reactionsExact identifier
application applno (NDA): 006488
application number: NDA006488
XylocaineLIDOCAINE HYDROCHLORIDE, EPINEPHRINE BITARTRATE INJECTION, SOLUTIONHenry Schein, Inc9e8d0318-b2fe-4084-aedf-de97f61605a82025-08-07Warnings, Adverse reactionsExact identifier
application applno (NDA): 006488
application number: NDA006488
XylocaineLIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATEProPharma Distribution386c23fd-1691-98b2-e063-6294a90ab0702025-07-18Warnings, Adverse reactionsExact identifier
application applno (NDA): 006488
application number: NDA006488
XylocaineLIDOCAINE HYDROCHLORIDEAsclemed USA, Inc.25370b0f-0ac6-4a03-abe6-d73d651921802025-05-31Warnings, Adverse reactionsExact identifier
application applno (NDA): 006488
application number: NDA006488
XYLOCAIN (LIDOCAINE HCl )XYLOCAINE (LIDOCAINE HCL )HF Acquisition Co LLC, DBA HealthFirste1838a93-7f2a-14f1-e053-2a95a90a8d692025-05-07Warnings, Adverse reactionsExact identifier
application applno (NDA): 006488
application number: NDA006488
XylocaineLIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATEFresenius Kabi USA, LLC4dd52202-8eef-4136-92dd-ada573b7cf742025-04-22Warnings, Adverse reactionsExact identifier
application applno (NDA): 006488
application number: NDA006488
XYLOCAINE MPFLIDOCAINE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirst1986c302-82a0-95a9-e063-6294a90a33392024-11-15Warnings, Adverse reactionsExact identifier
application applno (NDA): 006488
application number: NDA006488
XYLOCAINE MPFLIDOCAINE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirst199ac3eb-1fa5-9cf5-e063-6394a90a72282024-11-15Warnings, Adverse reactionsExact identifier
application applno (NDA): 006488
application number: NDA006488
XYLOCAINEXYLOCAINEHF Acquisition Co LLC, DBA HealthFirst17e77013-f2a0-b1f7-e063-6294a90ae4682024-05-29Warnings, Adverse reactionsExact identifier
application applno (NDA): 006488
application number: NDA006488
XYLOCAINE MPFXYLOCAINE MPFHF Acquisition Co LLC, DBA HealthFirst18705416-9593-43f2-e063-6294a90a31b42024-05-14Warnings, Adverse reactionsExact identifier
application applno (NDA): 006488
application number: NDA006488
Xylocaine MPFLIDOCAINE HYDROCHLORIDEFresenius Kabi USA, LLCd5e0d06f-ba1e-44d4-aa89-39d6c146dc232024-05-13Warnings, Adverse reactionsExact identifier
application applno (NDA): 006488
application number: NDA006488

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1010751lidocaine HCl 1 % / EPINEPHrine 1:100,000 Injectable SolutionPSNe52110a0-d180-53a1-e053-2995a90ae9b11
1010751epinephrine 0.01 MG/ML / lidocaine hydrochloride 10 MG/ML Injectable SolutionSCDe52110a0-d180-53a1-e053-2995a90ae9b11
1010751epinephrine (as epinephrine bitartrate) 1:100,000 / lidocaine hydrochloride 1 % Injectable SolutionSYe52110a0-d180-53a1-e053-2995a90ae9b11
1010751lidocaine HCl 1 % / EPINEPHrine 1:100,000 Injectable SolutionSYe52110a0-d180-53a1-e053-2995a90ae9b11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51662-1589-25166215890250 mL in 1 VIAL, MULTI-DOSE50 mlHistorical
51662-1589-35166215890325 POUCH in 1 CASE (51662-1589-3) > 1 VIAL, MULTI-DOSE in 1 POUCH (51662-1589-2) > 50 mL in 1 VIAL, MULTI-DOSE25 pouch2022-07-310000-00-00NoNoCurrent