FDA.reportPublic FDA data

Toxicology Saliva Collection Kit

Product NDC
69176-035
11-digit product format
691760035
Labeler code
69176
Product ID
69176-035_874a535a-03c0-41de-a21b-39222f0a4e61
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Toxicology Saliva Collection Kit
Dosage form
KIT
Route
ORAL
Labeler
TMIG, Inc.
Application
ANDA075682
Marketing category
ANDA
Marketing start
2015-01-30
Marketing end
0000-00-00
Active strength
0
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1e73f975-1ce7-705e-2bcf-788b1b5e24baProduct name520251124
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
f6d1b8d7-3bd1-4248-eddd-b60565c88015Product name420230808
874f4e63-49d2-5150-5d77-052172814ebdProduct name620230105
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
dbc9a339-6215-4e94-9546-57a3b34902ceProduct name120160517
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
997601aa-bb5f-6971-6b90-a21132c12c7bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69176-035-012020-01-31C16284748780-19d75b9d0-1a4d-f424-e053-dadaa90a57ceTOC Kit finalCopy of Tox Kit 2(Importer)Tox Kit (Importer)refence productsThese highlights do not include all the information needed to use Toxicology Saliva Collection Kit safely and effectively.see full prescribing information for Toxicology Saliva Collection KitToxicology Saliva Collection Kit (Toxicology Saliva Collection Kit) KIT for ORAL use.Initial U.S. Approval:These highlights do not include all the information needed to use Toxicology Saliva Collection Kit safely and effectively.see full prescribi

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69176-035-01Toxicology Saliva Collection Kit1 in 1 KITKIT16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69176-035-01EA - Each69176-035a5a38da5-0b0f-4138-bb2b-4a34eb9ed63c12015-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMTOXICOLOGY SALIVA COLLECTION KIT KIT [TMIG, INC.]6
IBUPROFENACTIVE MOIETYWK2XYI10QMTOXICOLOGY SALIVA COLLECTION KIT KIT [TMIG, INC.]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTOXICOLOGY SALIVA COLLECTION KIT KIT [TMIG, INC.]6
COPOVIDONEINACTIVE INGREDIENTD9C330MD8BTOXICOLOGY SALIVA COLLECTION KIT KIT [TMIG, INC.]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TOXICOLOGY SALIVA COLLECTION KIT KIT [TMIG, INC.]6
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HTOXICOLOGY SALIVA COLLECTION KIT KIT [TMIG, INC.]6
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TOXICOLOGY SALIVA COLLECTION KIT KIT [TMIG, INC.]6
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TOXICOLOGY SALIVA COLLECTION KIT KIT [TMIG, INC.]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69176-035TOXICOLOGY SALIVA COLLECTION KIT KIT [TMIG, INC.]6Legacy NDC, 1 package rows20150515_b85a83de-8bb5-4e22-9926-5f2a6f580ebc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197806ibuprofen 600 MG Oral TabletPSNb85a83de-8bb5-4e22-9926-5f2a6f580ebc6
197806ibuprofen 600 MG Oral TabletSCDb85a83de-8bb5-4e22-9926-5f2a6f580ebc6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
69176-035-01691760035011 in 1 KITHistorical