Tinidazole

Product NDC: 53002-1611
11-digit product format: 530021611
Labeler code: 53002
Product ID: 53002-1611_2d40e3ea-c6bb-4ddc-a3dd-f9085b596c67
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tinidazole
Dosage form: TABLET
Route: ORAL
Labeler: RPK Pharmaceuticals, Inc.
Application: ANDA203808
Marketing category: ANDA
Marketing start: 2019-12-20
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: 2021-12-31
Current FDA listing: Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f3ecf2e5-c042-aa76-e0af-284f60c6ce13	Product name	2	20150810

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53002-1611-1	2023-01-30	C162847	48780-1	9d75b9d1-1440-f424-e053-dadaa90a57ce	Tinidazole tablets for oral use These highlights do not include all the information needed to use tinidazole tablets safely and effectively. See full prescribing information for tinidazole tablets. Initial U.S. Approval: 2004
53002-1611-1	2020-12-15	C162847	48780-1	9d75b9d1-1440-f424-e053-dadaa90a57ce	Tinidazole tablets for oral use These highlights do not include all the information needed to use tinidazole tablets safely and effectively. See full prescribing information for tinidazole tablets. Initial U.S. Approval: 2004
53002-1611-1	2020-01-31	C162847	48780-1	9d75b9d1-1440-f424-e053-dadaa90a57ce	Tinidazole tablets for oral use These highlights do not include all the information needed to use tinidazole tablets safely and effectively. See full prescribing information for tinidazole tablets. Initial U.S. Approval: 2004

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53002-1611-1	Tinidazole	10 in 1 BOTTLE	TABLET	10		3

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53002-1611	TINIDAZOLE TABLET [RPK PHARMACEUTICALS, INC.]	3	Legacy NDC, 1 package rows	20201217_ebe89ab6-24c0-4214-853f-67e2e0c7daa9.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
033KF7V46H	TINIDAZOLE	19387-91-8	TINIDAZOLE

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
199519	tinidazole 500 MG Oral Tablet	PSN	ebe89ab6-24c0-4214-853f-67e2e0c7daa9	3
199519	tinidazole 500 MG Oral Tablet	SCD	ebe89ab6-24c0-4214-853f-67e2e0c7daa9	3

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53002-1611-1	53002161101	10 TABLET in 1 BOTTLE (53002-1611-1)	10 tablet	2019-12-20	0000-00-00	No	No	Current