FDA.reportPublic FDA data

Acunistat-60

Product NDC
70529-012
11-digit product format
705290012
Labeler code
70529
Product ID
70529-012_f6bdbecf-0533-4382-aa62-c6741e33fb4d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine Hydrochloride, Ketorolac Tromethamine
Dosage form
KIT
Labeler
IT3 Medical LLC
Application
ANDA088299
Marketing category
ANDA
Marketing start
2017-03-01
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
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
6a38bd75-79e3-96c0-1204-08a0282902aeProduct name420250128
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
4d6e22a5-3693-6edf-0179-2ab93aecbadbProduct name920240724
03452e68-2506-686e-a908-f2381c778fc6Product name520240307
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
bb41bc3a-c643-93c9-055f-a8f48f363af3Product name220190219
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
4f6a8082-ae1e-0ff7-4dc0-77f9f0f7b70cProduct name120140508
8d3e992f-8ff7-c106-f7eb-1e2d5eb12025Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70529-012-012023-07-28C16284748780-1d6a99b39-9fc0-a426-e053-dadaa90af4c2Acunistat-60 Injection System
70529-012-012022-03-01C16284748780-1d6a99b39-9fc0-a426-e053-dadaa90af4c2Acunistat-60 Injection System
70529-012-012022-01-28C16284748780-1d6a99b39-9fc0-a426-e053-dadaa90af4c2Acunistat-60 Injection System

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70529-012-01Acunistat-601 in 1 PACKAGEKIT14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70529-012ACUNISTAT-60 (LIDOCAINE HYDROCHLORIDE, KETOROLAC TROMETHAMINE) KIT [IT3 MEDICAL LLC]4Legacy NDC, 1 package rows20220302_a487b037-982f-467b-b2cf-3f25b2356ab2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
797544isopropyl alcohol 70 % Medicated PadPSNa487b037-982f-467b-b2cf-3f25b2356ab24
1665461ketorolac tromethamine 30 MG in 1 ML InjectionPSNa487b037-982f-467b-b2cf-3f25b2356ab24
1010033lidocaine HCl 1 % Injectable SolutionPSNa487b037-982f-467b-b2cf-3f25b2356ab24
16654611 ML ketorolac tromethamine 30 MG/ML InjectionSCDa487b037-982f-467b-b2cf-3f25b2356ab24
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCDa487b037-982f-467b-b2cf-3f25b2356ab24
1010033lidocaine hydrochloride 10 MG/ML Injectable SolutionSCDa487b037-982f-467b-b2cf-3f25b2356ab24
797544isopropyl alcohol 70 % Medicated PadSYa487b037-982f-467b-b2cf-3f25b2356ab24
797544isopropyl alcohol 70 % Topical ClothSYa487b037-982f-467b-b2cf-3f25b2356ab24
797544isopropyl alcohol 70 % Topical SwabSYa487b037-982f-467b-b2cf-3f25b2356ab24
1665461ketorolac tromethamine 30 MG per 1 ML InjectionSYa487b037-982f-467b-b2cf-3f25b2356ab24
1010033lidocaine hydrochloride 1 % Injectable SolutionSYa487b037-982f-467b-b2cf-3f25b2356ab24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70529-012-01705290012011 KIT in 1 PACKAGE (70529-012-01) * 2 mL in 1 VIAL, SINGLE-DOSE * 1 mL in 1 PACKET * 50 mL in 1 VIAL, MULTI-DOSE1 kit2017-03-010000-00-00NoNoCurrent