Sertraline

Product NDC: 50436-3520
11-digit product format: 504363520
Labeler code: 50436
Product ID: 50436-3520_951e97e8-b639-4b25-a820-35aa70671bf5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sertraline
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Unit Dose Services
Application: ANDA077670
Marketing category: ANDA
Marketing start: 2007-02-06
Marketing end: 0000-00-00
Substance: SERTRALINE HYDROCHLORIDE
Active strength: 50 mg/1
Pharmacologic classes: Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2019-12-31
Current FDA listing: Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
4ac594ea-ad8b-47fd-9b52-bbd98301675e	Product name	1	20220317
255fa467-900b-5557-4215-6823352d1150	Product name	2	20211028

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50436-3520-1	2020-01-31	C162847	48780-1	9d75b9cf-cefc-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use sertraline hydrochloride tablets safely and effectively. See full prescribing information for sertraline hydrochloride tablets. SERTRALINE hydrochloride tablets, for oral use Initial U.S. Approval: 1991

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50436-3520-1	Sertraline	30 in 1 BOTTLE	TABLET, FILM COATED	30		2

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50436-3520-1	EA - Each	50436-3520	117f0dd3-60b2-4e8b-b0c7-5622faf61b26	1	2018-08-13

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50436-3520	SERTRALINE TABLET, FILM COATED [UNIT DOSE SERVICES]	2	Legacy NDC, 1 package rows	20180618_a5fc39de-bdb4-4f60-9864-3c2b346c369a.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
UTI8907Y6X	SERTRALINE HYDROCHLORIDE	79559-97-0	SERTRALINE HYDROCHLORIDE
QUC7NX6WMB	SERTRALINE	79617-96-2	Sertraline

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
312941	sertraline HCl 50 MG Oral Tablet	PSN	a5fc39de-bdb4-4f60-9864-3c2b346c369a	2
312941	sertraline 50 MG Oral Tablet	SCD	a5fc39de-bdb4-4f60-9864-3c2b346c369a	2
312941	sertraline (as sertraline HCl) 50 MG Oral Tablet	SY	a5fc39de-bdb4-4f60-9864-3c2b346c369a	2

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
50436-3520-1	50436352001	30 in 1 BOTTLE	Historical