Tinidazole

Product NDC: 44523-425
11-digit product format: 445230425
Labeler code: 44523
Product ID: 44523-425_88bfdb3a-68d1-42c8-b74e-d1513a33ffa6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tinidazole
Dosage form: TABLET
Route: ORAL
Labeler: Biocomp Pharma, Inc.
Application: NDA021618
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2012-06-07
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: 2019-12-31
Current FDA listing: Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
44523-425-40	2020-06-02	C162847	48780-1	9d75b9d1-0831-f424-e053-dadaa90a57ce	Tinidazole tablets for oral use These highlights do not include all the information needed to use tinidazole safely and effectively. See full prescribing information for tinidazole. Initial U.S. Approval: 2004
44523-425-40	2020-01-31	C162847	48780-1	9d75b9d1-0831-f424-e053-dadaa90a57ce	Tinidazole tablets for oral use These highlights do not include all the information needed to use tinidazole safely and effectively. See full prescribing information for tinidazole. Initial U.S. Approval: 2004

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
44523-425-40	EA - Each	44523-425	daf9d36e-d405-4361-839e-d9baa4458ee1	1	2012-07-24