Tindazole

Product NDC
64980-427
11-digit product format
649800427
Labeler code
64980
Product ID
64980-427_8dbd79dd-9243-4413-aa01-ba1301573a48
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tinidazole
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA202489
Marketing category
ANDA
Marketing start
2013-10-09
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
Tindazole
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
64980-427-12Tindazole12 in 1 BOTTLE, PLASTICTABLET, FILM COATED126

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64980-427-12EA - Each64980-427823ee395-43ea-44c6-af2e-96b1d56b497512018-01-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64980-427TINDAZOLE (TINIDAZOLE) TABLET, FILM COATED [RISING PHARMA HOLDINGS, INC.]5Current NDC, Legacy NDC, 1 package rows20230707_32167dd7-5d37-457b-9b00-cd735de6b060.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
477234tinidazole 250 MG Oral TabletPSN32167dd7-5d37-457b-9b00-cd735de6b0606
199519tinidazole 500 MG Oral TabletPSN32167dd7-5d37-457b-9b00-cd735de6b0606
477234tinidazole 250 MG Oral TabletSCD32167dd7-5d37-457b-9b00-cd735de6b0606
199519tinidazole 500 MG Oral TabletSCD32167dd7-5d37-457b-9b00-cd735de6b0606
199519tinidazole 500 MG Oral TabletPSNf4235736-3050-1ee0-e053-2a95a90a421c2
199519tinidazole 500 MG Oral TabletSCDf4235736-3050-1ee0-e053-2a95a90a421c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
64980-427-126498004271212 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64980-427-12) 2013-10-090000-00-00NoNoCurrent