FDA.reportPublic FDA data

DX2 OraGenomic Medicated DNA Collection Screen

Product NDC
70529-442
11-digit product format
705290442
Labeler code
70529
Product ID
70529-442_91a023a5-5a4e-45d3-9c74-8da2f4354bf1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine Hydrochloride
Dosage form
KIT
Labeler
IT3 Medical LLC
Application
ANDA040014
Marketing category
ANDA
Marketing start
2016-05-01
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
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70529-442-022023-07-28C16284748780-1d6a99b39-d340-a426-e053-dadaa90af4c2DX2 OraGenomic Medicated DNA Collection Screen
70529-442-022022-03-01C16284748780-1d6a99b39-d340-a426-e053-dadaa90af4c2DX2 OraGenomic Medicated DNA Collection Screen
70529-442-022022-01-28C16284748780-1d6a99b39-d340-a426-e053-dadaa90af4c2DX2 OraGenomic Medicated DNA Collection Screen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50383-775-15DX2 OraGenomic Medicated DNA Collection Screen15 mL in 1 CUP, UNIT-DOSESOLUTION15 mL20 mg in 1mL4
63517-160-01DX2 OraGenomic Medicated DNA Collection Screen9 g in 1 PACKETSWAB9 g7.5 g in 100g4
68345-883-50DX2 OraGenomic Medicated DNA Collection Screen1.5 g in 1 PACKETLIQUID3 g0.13 g in 100g4
70529-442-02DX2 OraGenomic Medicated DNA Collection Screen1 in 1 PACKAGEKIT14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70529-442-02EA - Each70529-4423fc1f792-1752-40e6-8bf0-7586d65af0ca12022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70529-442DX2 ORAGENOMIC MEDICATED DNA COLLECTION SCREEN (LIDOCAINE HYDROCHLORIDE) KIT [IT3 MEDICAL LLC]4Legacy NDC, 4 package rows20220302_f51bb899-9186-4654-afe6-e6f89ad8370d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038558benzalkonium chloride 0.13 % Medicated PadPSNf51bb899-9186-4654-afe6-e6f89ad8370d4
1114098glycerin 7.5 % Medicated PadPSNf51bb899-9186-4654-afe6-e6f89ad8370d4
1010739lidocaine HCl 2 % Mucous Membrane Topical SolutionPSNf51bb899-9186-4654-afe6-e6f89ad8370d4
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCDf51bb899-9186-4654-afe6-e6f89ad8370d4
1114098glycerin 75 MG/ML Medicated PadSCDf51bb899-9186-4654-afe6-e6f89ad8370d4
1010739lidocaine hydrochloride 20 MG/ML Mucous Membrane Topical SolutionSCDf51bb899-9186-4654-afe6-e6f89ad8370d4
1038558benzalkonium chloride 0.13 % Topical ClothSYf51bb899-9186-4654-afe6-e6f89ad8370d4
1038558benzalkonium chloride 0.13 % Topical SwabSYf51bb899-9186-4654-afe6-e6f89ad8370d4
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSYf51bb899-9186-4654-afe6-e6f89ad8370d4
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSYf51bb899-9186-4654-afe6-e6f89ad8370d4
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSYf51bb899-9186-4654-afe6-e6f89ad8370d4
1114098glycerin 7.5 % Medicated SwabSYf51bb899-9186-4654-afe6-e6f89ad8370d4
1010739lidocaine HCl 2 % Oral Topical SolutionSYf51bb899-9186-4654-afe6-e6f89ad8370d4
1010739lidocaine HCl 2 % Oromucosal SolutionSYf51bb899-9186-4654-afe6-e6f89ad8370d4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50383-775-155038307751515 mL in 1 CUP, UNIT-DOSE15 mlHistorical
63517-160-01635170160019 g in 1 PACKET9 gHistorical
68345-883-50683450883501.5 g in 1 PACKET1.5 gHistorical
70529-442-02705290442021 KIT in 1 PACKAGE (70529-442-02) * 1.5 g in 1 PACKET (68345-883-50) * 9 g in 1 PACKET (63517-160-01) * 15 mL in 1 CUP, UNIT-DOSE (50383-775-15) 1 kit2016-05-010000-00-00NoNoCurrent