FDA.reportPublic FDA data

DX1 OraGenomic Medicated DNA Collection Screen

Product NDC
70529-441
11-digit product format
705290441
Labeler code
70529
Product ID
70529-441_1b324ab5-3467-43d7-bf47-c8aebc7dccf2
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
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
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
70529-441-012023-07-28C16284748780-1d6a99b39-d33a-a426-e053-dadaa90af4c2DX1 OraGenomic Medicated DNA Collection Screen
70529-441-012022-03-01C16284748780-1d6a99b39-d33a-a426-e053-dadaa90af4c2DX1 OraGenomic Medicated DNA Collection Screen
70529-441-012022-01-28C16284748780-1d6a99b39-d33a-a426-e053-dadaa90af4c2DX1 OraGenomic Medicated DNA Collection Screen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50383-775-15DX1 OraGenomic Medicated DNA Collection Screen15 mL in 1 CUP, UNIT-DOSESOLUTION15 mL20 mg in 1mL4
63517-160-01DX1 OraGenomic Medicated DNA Collection Screen9 g in 1 PACKETSWAB9 g7.5 g in 100g4
68345-883-50DX1 OraGenomic Medicated DNA Collection Screen1.5 g in 1 PACKETLIQUID3 g0.13 g in 100g4
70529-441-01DX1 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
70529-441-01EA - Each70529-441e5b49cbe-d2e6-44b8-b0bb-51254ce8b95e12022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70529-441DX1 ORAGENOMIC MEDICATED DNA COLLECTION SCREEN (LIDOCAINE HYDROCHLORIDE) KIT [IT3 MEDICAL LLC]4Legacy NDC, 4 package rows20220302_802fe200-8aad-464c-84f7-74d1809c4dd8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038558benzalkonium chloride 0.13 % Medicated PadPSN802fe200-8aad-464c-84f7-74d1809c4dd84
1114098glycerin 7.5 % Medicated PadPSN802fe200-8aad-464c-84f7-74d1809c4dd84
1010739lidocaine HCl 2 % Mucous Membrane Topical SolutionPSN802fe200-8aad-464c-84f7-74d1809c4dd84
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCD802fe200-8aad-464c-84f7-74d1809c4dd84
1114098glycerin 75 MG/ML Medicated PadSCD802fe200-8aad-464c-84f7-74d1809c4dd84
1010739lidocaine hydrochloride 20 MG/ML Mucous Membrane Topical SolutionSCD802fe200-8aad-464c-84f7-74d1809c4dd84
1038558benzalkonium chloride 0.13 % Topical ClothSY802fe200-8aad-464c-84f7-74d1809c4dd84
1038558benzalkonium chloride 0.13 % Topical SwabSY802fe200-8aad-464c-84f7-74d1809c4dd84
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSY802fe200-8aad-464c-84f7-74d1809c4dd84
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSY802fe200-8aad-464c-84f7-74d1809c4dd84
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSY802fe200-8aad-464c-84f7-74d1809c4dd84
1114098glycerin 7.5 % Medicated SwabSY802fe200-8aad-464c-84f7-74d1809c4dd84
1010739lidocaine HCl 2 % Oral Topical SolutionSY802fe200-8aad-464c-84f7-74d1809c4dd84
1010739lidocaine HCl 2 % Oromucosal SolutionSY802fe200-8aad-464c-84f7-74d1809c4dd84

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
70529-441-01705290441011 KIT in 1 PACKAGE (70529-441-01) * 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