Lixtraxen 1%

Product NDC
70529-100
11-digit product format
705290100
Labeler code
70529
Product ID
70529-100_9f237a31-42be-44a3-a985-67b8ef245516
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine Hydrochloride and Epinephrine
Dosage form
INJECTION, SOLUTION
Route
INFILTRATION; PERINEURAL
Labeler
IT3 Medical LLC
Application
ANDA089644
Marketing category
ANDA
Marketing start
2019-01-01
Marketing end
0000-00-00
Substance
EPINEPHRINE; LIDOCAINE HYDROCHLORIDE
Active strength
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
2023-12-31
Current FDA listing
Historical FDA.report record

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70529-100-012023-07-28C16284748780-1d6a99b39-9e46-a426-e053-dadaa90af4c2Lixtraxen 1% Injection System
70529-100-032023-07-28C16284748780-1d6a99b39-9e46-a426-e053-dadaa90af4c2Lixtraxen 1% Injection System
70529-100-052023-07-28C16284748780-1d6a99b39-9e46-a426-e053-dadaa90af4c2Lixtraxen 1% Injection System
70529-100-112023-07-28C16284748780-1d6a99b39-9e46-a426-e053-dadaa90af4c2Lixtraxen 1% Injection System
70529-100-132023-07-28C16284748780-1d6a99b39-9e46-a426-e053-dadaa90af4c2Lixtraxen 1% Injection System
70529-100-152023-07-28C16284748780-1d6a99b39-9e46-a426-e053-dadaa90af4c2Lixtraxen 1% Injection System
70529-100-012022-03-01C16284748780-1d6a99b39-9e46-a426-e053-dadaa90af4c2Lixtraxen 1% Injection System
70529-100-032022-03-01C16284748780-1d6a99b39-9e46-a426-e053-dadaa90af4c2Lixtraxen 1% Injection System
70529-100-052022-03-01C16284748780-1d6a99b39-9e46-a426-e053-dadaa90af4c2Lixtraxen 1% Injection System
70529-100-112022-03-01C16284748780-1d6a99b39-9e46-a426-e053-dadaa90af4c2Lixtraxen 1% Injection System
70529-100-132022-03-01C16284748780-1d6a99b39-9e46-a426-e053-dadaa90af4c2Lixtraxen 1% Injection System
70529-100-152022-03-01C16284748780-1d6a99b39-9e46-a426-e053-dadaa90af4c2Lixtraxen 1% Injection System
70529-100-012022-01-28C16284748780-1d6a99b39-9e46-a426-e053-dadaa90af4c2Lixtraxen 1% Injection System
70529-100-032022-01-28C16284748780-1d6a99b39-9e46-a426-e053-dadaa90af4c2Lixtraxen 1% Injection System
70529-100-052022-01-28C16284748780-1d6a99b39-9e46-a426-e053-dadaa90af4c2Lixtraxen 1% Injection System
70529-100-112022-01-28C16284748780-1d6a99b39-9e46-a426-e053-dadaa90af4c2Lixtraxen 1% Injection System
70529-100-132022-01-28C16284748780-1d6a99b39-9e46-a426-e053-dadaa90af4c2Lixtraxen 1% Injection System
70529-100-152022-01-28C16284748780-1d6a99b39-9e46-a426-e053-dadaa90af4c2Lixtraxen 1% Injection System

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70529-100-01Lixtraxen 1%1 in 1 PACKAGEINJECTION, SOLUTION12
70529-100-01Lixtraxen 1%20 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION202
70529-100-03Lixtraxen 1%20 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION202
70529-100-03Lixtraxen 1%2 in 1 PACKAGEINJECTION, SOLUTION22
70529-100-05Lixtraxen 1%20 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION202
70529-100-05Lixtraxen 1%3 in 1 PACKAGEINJECTION, SOLUTION32
70529-100-11Lixtraxen 1%1 in 1 PACKAGEINJECTION, SOLUTION12
70529-100-11Lixtraxen 1%30 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION302
70529-100-13Lixtraxen 1%30 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION302
70529-100-13Lixtraxen 1%2 in 1 PACKAGEINJECTION, SOLUTION22
70529-100-15Lixtraxen 1%3 in 1 PACKAGEINJECTION, SOLUTION32
70529-100-15Lixtraxen 1%30 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70529-100LIXTRAXEN 1% (LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE) INJECTION, SOLUTION [IT3 MEDICAL LLC]2Legacy NDC, 12 package rows20220302_61d39a4f-f65d-4ded-8c2d-972d56c1f35a.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70529-100-01705290100011 VIAL, MULTI-DOSE in 1 PACKAGE (70529-100-01) > 20 mL in 1 VIAL, MULTI-DOSE2019-01-010000-00-00NoNoCurrent
70529-100-03705290100032 VIAL, MULTI-DOSE in 1 PACKAGE (70529-100-03) > 20 mL in 1 VIAL, MULTI-DOSE2019-01-010000-00-00NoNoCurrent
70529-100-05705290100053 VIAL, MULTI-DOSE in 1 PACKAGE (70529-100-05) > 20 mL in 1 VIAL, MULTI-DOSE2019-01-010000-00-00NoNoCurrent
70529-100-11705290100111 VIAL, MULTI-DOSE in 1 PACKAGE (70529-100-11) > 30 mL in 1 VIAL, MULTI-DOSE2019-01-010000-00-00NoNoCurrent
70529-100-13705290100132 VIAL, MULTI-DOSE in 1 PACKAGE (70529-100-13) > 30 mL in 1 VIAL, MULTI-DOSE2019-01-010000-00-00NoNoCurrent
70529-100-15705290100153 VIAL, MULTI-DOSE in 1 PACKAGE (70529-100-15) > 30 mL in 1 VIAL, MULTI-DOSE2019-01-010000-00-00NoNoCurrent