FDA.reportPublic FDA data

Tinidazole

Product NDC
42799-208
11-digit product format
427990208
Labeler code
42799
Product ID
42799-208_462f7240-9709-4782-e063-6294a90a9e28
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tinidazole
Dosage form
TABLET
Route
ORAL
Labeler
Edenbridge Pharmaceuticals LLC.
Application
ANDA203808
Marketing category
ANDA
Marketing start
2019-12-20
Substance
TINIDAZOLE
Active strength
500 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
Tinidazole
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TINIDAZOLE500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii033KF7V46H
Rxcui199519, 477234

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42799-208-01Tinidazole20 in 1 BOTTLETABLET209
42799-208-02Tinidazole60 in 1 BOTTLETABLET609

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42799-208-01EA - Each42799-208324f7f00-d9d1-47ff-a4be-b1abb493812b12015-09-10
42799-208-02EA - Each42799-208d53c4c70-0b70-4d84-b3b8-92cdd16853c612015-09-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TinidazoleACTIVE INGREDIENT033KF7V46HTINIDAZOLE TABLET [EDENBRIDGE PHARMACEUTICALS, LLC]3
TinidazoleACTIVE MOIETY033KF7V46HTINIDAZOLE TABLET [EDENBRIDGE PHARMACEUTICALS, LLC]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTINIDAZOLE TABLET [EDENBRIDGE PHARMACEUTICALS, LLC]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48TINIDAZOLE TABLET [EDENBRIDGE PHARMACEUTICALS, LLC]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTTINIDAZOLE TABLET [EDENBRIDGE PHARMACEUTICALS, LLC]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOTINIDAZOLE TABLET [EDENBRIDGE PHARMACEUTICALS, LLC]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TINIDAZOLE TABLET [EDENBRIDGE PHARMACEUTICALS, LLC]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ATINIDAZOLE TABLET [EDENBRIDGE PHARMACEUTICALS, LLC]3
POVIDONE K30INACTIVE INGREDIENTU725QWY32XTINIDAZOLE TABLET [EDENBRIDGE PHARMACEUTICALS, LLC]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TINIDAZOLE TABLET [EDENBRIDGE PHARMACEUTICALS, LLC]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTINIDAZOLE TABLET [EDENBRIDGE PHARMACEUTICALS, LLC]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTINIDAZOLE TABLET [EDENBRIDGE PHARMACEUTICALS, LLC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42799-208TINIDAZOLE TABLET [EDENBRIDGE PHARMACEUTICALS LLC.]7Current NDC, Legacy NDC, 2 package rows20250406_6f3ce597-64c1-4204-a67a-8b6f6e7e8bca.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
477234tinidazole 250 MG Oral TabletPSN6f3ce597-64c1-4204-a67a-8b6f6e7e8bca9
199519tinidazole 500 MG Oral TabletPSN6f3ce597-64c1-4204-a67a-8b6f6e7e8bca9
477234tinidazole 250 MG Oral TabletSCD6f3ce597-64c1-4204-a67a-8b6f6e7e8bca9
199519tinidazole 500 MG Oral TabletSCD6f3ce597-64c1-4204-a67a-8b6f6e7e8bca9
199519tinidazole 500 MG Oral TabletPSNebe89ab6-24c0-4214-853f-67e2e0c7daa93
199519tinidazole 500 MG Oral TabletSCDebe89ab6-24c0-4214-853f-67e2e0c7daa93

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42799-208-014279902080120 TABLET in 1 BOTTLE (42799-208-01) 20 tablet2019-12-200000-00-00NoNoCurrent
42799-208-024279902080260 TABLET in 1 BOTTLE (42799-208-02) 60 tablet2019-12-200000-00-00NoNoCurrent