FDA.reportPublic FDA data

Tinidazole

Product NDC
40032-550
11-digit product format
400320550
Labeler code
40032
Product ID
40032-550_530af487-7e0b-4ad5-a45b-3f7d9b1b71ae
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tinidazole
Dosage form
TABLET
Route
ORAL
Labeler
Novel Laboratories, Inc.
Application
ANDA202044
Marketing category
ANDA
Marketing start
2012-04-30
Marketing end
0000-00-00
Substance
TINIDAZOLE
Active strength
250 mg/1
Pharmacologic classes
Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [CS]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f3ecf2e5-c042-aa76-e0af-284f60c6ce13Product name220150810

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
40032-550-082020-01-31C16284748780-19d75b9d0-ef86-f424-e053-dadaa90a57ceTinidazole Tablets Novel Laboratories, Inc. These highlights do not include all the information needed to use Tinidazole safely and effectively. See full prescribing information for Tinidazole. Tinidazole (Tinidazole) TABLET for ORAL use. Initial U.S. Approval: 2004
40032-550-402020-01-31C16284748780-19d75b9d0-ef86-f424-e053-dadaa90a57ceTinidazole Tablets Novel Laboratories, Inc. These highlights do not include all the information needed to use Tinidazole safely and effectively. See full prescribing information for Tinidazole. Tinidazole (Tinidazole) TABLET for ORAL use. Initial U.S. Approval: 2004

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
40032-550-08Tinidazole8 in 1 BOTTLETABLET83
40032-550-40Tinidazole40 in 1 BOTTLETABLET403

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TINIDAZOLEACTIVE INGREDIENT033KF7V46HTINIDAZOLE TABLET [NOVEL LABORATORIES, INC.]3
TINIDAZOLEACTIVE MOIETY033KF7V46HTINIDAZOLE TABLET [NOVEL LABORATORIES, INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTINIDAZOLE TABLET [NOVEL LABORATORIES, INC.]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48TINIDAZOLE TABLET [NOVEL LABORATORIES, INC.]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOATINIDAZOLE TABLET [NOVEL LABORATORIES, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TINIDAZOLE TABLET [NOVEL LABORATORIES, INC.]3
POLYETHYLENE GLYCOL 3000INACTIVE INGREDIENTSA1B764746TINIDAZOLE TABLET [NOVEL LABORATORIES, INC.]3
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990TINIDAZOLE TABLET [NOVEL LABORATORIES, INC.]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTINIDAZOLE TABLET [NOVEL LABORATORIES, INC.]3
TALCINACTIVE INGREDIENT7SEV7J4R1UTINIDAZOLE TABLET [NOVEL LABORATORIES, INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTINIDAZOLE TABLET [NOVEL LABORATORIES, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
40032-550TINIDAZOLE TABLET [NOVEL LABORATORIES, INC.]3Legacy NDC, 2 package rows20120529_4e03b4ac-c88a-4044-9d58-0cfcda3db53c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
477234tinidazole 250 MG Oral TabletPSN4e03b4ac-c88a-4044-9d58-0cfcda3db53c3
199519tinidazole 500 MG Oral TabletPSN4e03b4ac-c88a-4044-9d58-0cfcda3db53c3
477234tinidazole 250 MG Oral TabletSCD4e03b4ac-c88a-4044-9d58-0cfcda3db53c3
199519tinidazole 500 MG Oral TabletSCD4e03b4ac-c88a-4044-9d58-0cfcda3db53c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
40032-550-08400320550088 in 1 BOTTLEHistorical
40032-550-404003205504040 in 1 BOTTLEHistorical