FDA.reportPublic FDA data

Lidocaine Hydrochloride and Epinephrine

Product NDC
84549-182
Requested package NDC
84549-182-03
11-digit product format
845490182
Labeler code
84549
Product ID
84549-182_463ecfc4-b5fa-62dd-e063-6294a90a9404
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LIDOCAINE HYDROCHLORIDE and EPINEPHRINE
Dosage form
INJECTION, SOLUTION
Route
INFILTRATION; PERINEURAL
Labeler
ProPharma Distribution
Application
ANDA089646
Marketing category
ANDA
Marketing start
2005-06-23
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

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A089646-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.01MG/ML;2%INJECTABLE / INJECTIONRS1988-06-21a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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
ndc (package): 84549-182-03
ndc (product): 84549-182
ndc11 (package): 84549018203
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
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

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
43048b6b-3c83-eef4-e063-6294a90a34cbAvailable 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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
2686d634-e712-4007-8dbf-3d37c6c4d71fProduct name120181121
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
bd49bb86-2d32-4a7a-a594-eeda2e29af42Product name120180118
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
3becbe78-12d9-4ad2-9b4c-1e36f8d1303aProduct name120170815
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
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
84549-182-03Lidocaine Hydrochloride and Epinephrine50 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION502

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1010759lidocaine HCl 2 % / EPINEPHrine 1:100,000 Injectable SolutionPSN43048b6b-3c83-eef4-e063-6294a90a34cb2
1010759epinephrine 0.01 MG/ML / lidocaine hydrochloride 20 MG/ML Injectable SolutionSCD43048b6b-3c83-eef4-e063-6294a90a34cb2
1010759epinephrine (as epinephrine bitartrate) 1:100,000 / lidocaine hydrochloride 2 % Injectable SolutionSY43048b6b-3c83-eef4-e063-6294a90a34cb2
1010759epinephrine 1:100,000 / lidocaine hydrochloride 2 % Injectable SolutionSY43048b6b-3c83-eef4-e063-6294a90a34cb2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84549-182-038454901820350 mL in 1 VIAL, MULTI-DOSE (84549-182-03) 50 ml2025-10-10NoNoCurrent