Ludaxine

Product NDC
70529-053
11-digit product format
705290053
Labeler code
70529
Product ID
70529-053_5bd933f0-2d73-4fda-8dff-f1e248b7cf02
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dexamethasone Sodium Phosphate, Bupivacaine Hydrochloride
Dosage form
KIT
Labeler
IT3 Medical LLC
Application
ANDA206781
Marketing category
ANDA
Marketing start
2018-11-01
Marketing end
0000-00-00
Active strength
0
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
cbf85893-59ef-423f-87d4-a573c000a8b9Product name820250731
5dad6767-dcd1-b0da-8727-7f3f7bc3a435Product name220250303
1ea46721-9071-6b81-fd0a-a82bfbb014ecProduct name720250220
525701df-f985-480d-995a-e0ee70c2bdf4Product name520250128
ea50b939-d92a-4100-84f5-1c1089663837Product name220240705
941f67d9-7f03-56d2-750c-36de24f654dbProduct name320221117
d7d46a10-8766-d3c8-ebf2-2ccd9efdcae8Product name220220506
7b2c58e8-5850-4e3e-82e9-b1593b1de761Product name520220210
e3a99641-4540-4894-9108-00cab3c57b7eProduct name120211207
5da98533-f072-406b-9e1b-6ac19eca9926Product name120210622
306b993e-3140-4823-ad5e-88b708f9d2acProduct name120210510
a831e694-3663-4a83-82be-6c309429f750Product name220200608
81e34474-b0a5-434f-8104-25d689efc99eProduct name120200303
05ab9c01-cd9a-4f59-b2e8-ddcb887cac39Product name120190408
0c7dba41-c919-5809-508d-4affe6cfcff2Product name220170817
399647c0-db89-02d1-991c-0c17b584482cProduct name120140508
3e9a6377-704f-dff7-b19f-56c98d40c444Product name120140508
4d2e6ff9-14f5-b84f-c39b-373b005712c1Product name120140508
725d71bf-f956-5cad-e556-fa39cb060dc8Product name120140508
9ea85abb-fa68-5da6-ab60-2c7eef579000Product name120140508
d029211e-5e6b-725f-3696-ac6ff77da222Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70529-053-012023-07-28C16284748780-1d6a99b39-ed1b-a426-e053-dadaa90af4c2Ludaxine Injection System
70529-053-012022-03-01C16284748780-1d6a99b39-ed1b-a426-e053-dadaa90af4c2Ludaxine Injection System
70529-053-012022-01-28C16284748780-1d6a99b39-ed1b-a426-e053-dadaa90af4c2Ludaxine Injection System

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70529-053-01Ludaxine1 in 1 PACKAGEKIT13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70529-053LUDAXINE (DEXAMETHASONE SODIUM PHOSPHATE, BUPIVACAINE HYDROCHLORIDE) KIT [IT3 MEDICAL LLC]3Legacy NDC, 1 package rows20220302_d19bf48e-b64e-4fe4-82ab-12cb444e92c4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1012404BUPivacaine HCl 0.5 % Injectable SolutionPSNd19bf48e-b64e-4fe4-82ab-12cb444e92c43
1116927dexAMETHasone sodium phosphate 4 MG/ML (dexAMETHasone phosphate equivalent) Injectable SolutionPSNd19bf48e-b64e-4fe4-82ab-12cb444e92c43
1012404bupivacaine hydrochloride 5 MG/ML Injectable SolutionSCDd19bf48e-b64e-4fe4-82ab-12cb444e92c43
1116927dexamethasone phosphate 4 MG/ML Injectable SolutionSCDd19bf48e-b64e-4fe4-82ab-12cb444e92c43
1012404bupivacaine hydrochloride 0.5 % Injectable SolutionSYd19bf48e-b64e-4fe4-82ab-12cb444e92c43
1116927dexamethasone phosphate 4 MG/ML (as dexamethasone sodium phosphate 4.4 MG/ML) Injectable SolutionSYd19bf48e-b64e-4fe4-82ab-12cb444e92c43

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70529-053-01705290053011 KIT in 1 PACKAGE (70529-053-01) * 30 mL in 1 VIAL, MULTI-DOSE * 50 mL in 1 VIAL, MULTI-DOSE1 kit2018-11-010000-00-00NoNoCurrent