FDA.reportPublic FDA data

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

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

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