LIDOCAINE HCI AND EPINEPHRINE WITH EPINEPHRINE

Product NDC
51662-1412
11-digit product format
516621412
Labeler code
51662
Product ID
51662-1412_0f906587-01ab-1870-e063-6294a90a3393
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LIDOCAINE HCI AND EPINEPHRINE WITH EPINEPHRINE
Dosage form
INJECTION, SOLUTION
Route
EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL
Labeler
HF Acquisition Co LLC, DBA HealthFirst
Application
NDA006488
Marketing category
NDA
Marketing start
2019-10-14
Substance
EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE ANHYDROUS
Active strength
.005; 20 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
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 · 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…

Additional Listing Data#

Finished product
Yes
Brand name base
LIDOCAINE HCI AND EPINEPHRINE WITH EPINEPHRINE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
EPINEPHRINE BITARTRATE.005 mg/mL
LIDOCAINE HYDROCHLORIDE ANHYDROUS20 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
30Q7KI53AKInternal UNII lookup
EC2CNF7XFPInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1868028Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
94e9f2db-af29-032e-e053-2995a90a7f7bAvailable 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51662-1412-1LIDOCAINE HCI AND EPINEPHRINE WITH EPINEPHRINE10 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION105
51662-1412-2LIDOCAINE HCI AND EPINEPHRINE WITH EPINEPHRINE1 in 1 POUCHINJECTION, SOLUTION15
51662-1412-2LIDOCAINE HCI AND EPINEPHRINE WITH EPINEPHRINE10 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION105
51662-1412-3LIDOCAINE HCI AND EPINEPHRINE WITH EPINEPHRINE25 in 1 BOXINJECTION, SOLUTION255

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51662-1412LIDOCAINE HCI AND EPINEPHRINE WITH EPINEPHRINE INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST]5Current NDC, Legacy NDC, 4 package rows20240123_94e9f2db-af29-032e-e053-2995a90a7f7b.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
1868028lidocaine HCl 2 % / EPINEPHrine 1:200,000 in 10 ML InjectionPSN94e9f2db-af29-032e-e053-2995a90a7f7b5
186802810 ML epinephrine 0.005 MG/ML / lidocaine hydrochloride 20 MG/ML InjectionSCD94e9f2db-af29-032e-e053-2995a90a7f7b5
1868028lidocaine HCl 2 % / EPINEPHrine 1:200,000 per 10 ML InjectionSY94e9f2db-af29-032e-e053-2995a90a7f7b5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51662-1412-15166214120110 mL in 1 VIAL, SINGLE-DOSE (51662-1412-1) 10 ml2019-10-140000-00-00NoNoCurrent
51662-1412-2516621412021 in 1 POUCHHistorical
51662-1412-35166214120325 POUCH in 1 BOX (51662-1412-3) / 1 VIAL, SINGLE-DOSE in 1 POUCH (51662-1412-2) / 10 mL in 1 VIAL, SINGLE-DOSE25 pouch2022-03-160000-00-00NoNoCurrent