Tinidazole

Product NDC
0054-0348
11-digit product format
000540348
Labeler code
0054
Product ID
0054-0348_44dc735d-c062-4a4d-a74d-3823b461efcf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tinidazole
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA201172
Marketing category
ANDA
Marketing start
2012-04-30
Marketing end
0000-00-00
Substance
TINIDAZOLE
Active strength
500 mg/1
Pharmacologic classes
Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0054-0348-07EA - Each0054-03485f06f183-3b09-4b9c-918a-eaee7657605c12012-07-24
0054-0348-21EA - Each0054-0348fc69abd7-49f4-464b-bf1e-0b510b96bd0512012-07-24

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199519tinidazole 500 MG Oral TabletPSN9719883b-496d-42bb-e053-2995a90a1ab16
199519tinidazole 500 MG Oral TabletSCD9719883b-496d-42bb-e053-2995a90a1ab16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0054-0348-070005403480720 TABLET, FILM COATED in 1 BOTTLE (0054-0348-07) 2012-04-300000-00-00NoNoCurrent
0054-0348-210005403482160 TABLET, FILM COATED in 1 BOTTLE (0054-0348-21) 2012-04-300000-00-00NoNoCurrent