Tinidazole

Product NDC
0054-0347
11-digit product format
000540347
Labeler code
0054
Product ID
0054-0347_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
250 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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0054-0347-16EA - Each0054-03470f3ea5ef-0cd4-4893-9354-95d8beeca23e12012-07-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0054-0347-160005403471640 TABLET, FILM COATED in 1 BOTTLE (0054-0347-16) 2012-04-300000-00-00NoNoCurrent