FDA.reportPublic FDA data

Tindamax

Product NDC
0178-8250
11-digit product format
001788250
Labeler code
0178
Product ID
0178-8250_d423971d-34c8-c7d2-e053-2a95a90abe74
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tinidazole
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Mission Pharmacal Company
Application
NDA021618
Marketing category
NDA
Marketing start
2004-05-17
Substance
TINIDAZOLE
Active strength
250 mg/1
Pharmacologic classes
Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Tindamax
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TINIDAZOLE250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii033KF7V46H
Rxcui199519, 477234, 539809, 539811

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
0178-8250-402020-10-15C16284748780-19d75b9d0-e188-f424-e053-dadaa90a57ceTindamax ® (tinidazole) oral tablets These highlights do not include all the information needed to use Tindamax ® safely and effectively. See full prescribing information for Tindamax. Tindamax ® (tinidazole) oral tablets for oral solution. Initial U.S. Approval 2004
0178-8250-402020-01-31C16284748780-19d75b9d0-e188-f424-e053-dadaa90a57ceTindamax ® (tinidazole) oral tablets These highlights do not include all the information needed to use Tindamax ® safely and effectively. See full prescribing information for Tindamax. Tindamax ® (tinidazole) oral tablets for oral solution. Initial U.S. Approval 2004

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0178-8250-40Tindamax40 in 1 BOTTLETABLET, FILM COATED409

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0178-8250-40EA - Each0178-8250175058e9-31d8-4cf1-bbf9-35912e3bdd6812013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TinidazoleACTIVE INGREDIENT033KF7V46HTINDAMAX (TINIDAZOLE) TABLET, FILM COATED [MISSION PHARMACAL COMPANY]3
TinidazoleACTIVE MOIETY033KF7V46HTINDAMAX (TINIDAZOLE) TABLET, FILM COATED [MISSION PHARMACAL COMPANY]3
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933TINDAMAX (TINIDAZOLE) TABLET, FILM COATED [MISSION PHARMACAL COMPANY]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTINDAMAX (TINIDAZOLE) TABLET, FILM COATED [MISSION PHARMACAL COMPANY]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48TINDAMAX (TINIDAZOLE) TABLET, FILM COATED [MISSION PHARMACAL COMPANY]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOATINDAMAX (TINIDAZOLE) TABLET, FILM COATED [MISSION PHARMACAL COMPANY]3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8TINDAMAX (TINIDAZOLE) TABLET, FILM COATED [MISSION PHARMACAL COMPANY]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOTINDAMAX (TINIDAZOLE) TABLET, FILM COATED [MISSION PHARMACAL COMPANY]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TINDAMAX (TINIDAZOLE) TABLET, FILM COATED [MISSION PHARMACAL COMPANY]3
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IETINDAMAX (TINIDAZOLE) TABLET, FILM COATED [MISSION PHARMACAL COMPANY]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ATINDAMAX (TINIDAZOLE) TABLET, FILM COATED [MISSION PHARMACAL COMPANY]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTINDAMAX (TINIDAZOLE) TABLET, FILM COATED [MISSION PHARMACAL COMPANY]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTINDAMAX (TINIDAZOLE) TABLET, FILM COATED [MISSION PHARMACAL COMPANY]3
TRIACETININACTIVE INGREDIENTXHX3C3X673TINDAMAX (TINIDAZOLE) TABLET, FILM COATED [MISSION PHARMACAL COMPANY]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0178-8250TINDAMAX (TINIDAZOLE) TABLET, FILM COATED [MISSION PHARMACAL COMPANY]9Current NDC, Legacy NDC, 1 package rows20211228_a0d01539-8413-4703-94cc-d221918630a1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
539809TINDAMAX 250 MG Oral TabletPSNa0d01539-8413-4703-94cc-d221918630a19
539811TINDAMAX 500 MG Oral TabletPSNa0d01539-8413-4703-94cc-d221918630a19
477234tinidazole 250 MG Oral TabletPSNa0d01539-8413-4703-94cc-d221918630a19
199519tinidazole 500 MG Oral TabletPSNa0d01539-8413-4703-94cc-d221918630a19
539809tinidazole 250 MG Oral Tablet [Tindamax]SBDa0d01539-8413-4703-94cc-d221918630a19
539811tinidazole 500 MG Oral Tablet [Tindamax]SBDa0d01539-8413-4703-94cc-d221918630a19
477234tinidazole 250 MG Oral TabletSCDa0d01539-8413-4703-94cc-d221918630a19
199519tinidazole 500 MG Oral TabletSCDa0d01539-8413-4703-94cc-d221918630a19
539809TINDAMAX 250 MG Oral TabletSYa0d01539-8413-4703-94cc-d221918630a19
539811TINDAMAX 500 MG Oral TabletSYa0d01539-8413-4703-94cc-d221918630a19

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0178-8250-400017882504040 TABLET, FILM COATED in 1 BOTTLE (0178-8250-40) 2004-05-170000-00-00NoNoCurrent