Sertraline

Product NDC: 53217-380
11-digit product format: 532170380
Labeler code: 53217
Product ID: 53217-380_761731ad-c843-4355-a018-80b046f8bfd5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sertraline
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Aidarex Pharmaceuticals LLC
Application: ANDA077670
Marketing category: ANDA
Marketing start: 2018-06-15
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
53217-380-30	2020-01-31	C162847	48780-1	9d75b9d0-6262-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
53217-380-30	Sertraline	30 in 1 BOTTLE	TABLET, FILM COATED	30		1

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53217-380	SERTRALINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1	Legacy NDC, 1 package rows	20180825_aaffdd32-b857-4070-b597-e29d4738ae59.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	aaffdd32-b857-4070-b597-e29d4738ae59	1
312941	sertraline 50 MG Oral Tablet	SCD	aaffdd32-b857-4070-b597-e29d4738ae59	1
312941	sertraline (as sertraline HCl) 50 MG Oral Tablet	SY	aaffdd32-b857-4070-b597-e29d4738ae59	1

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
53217-380-30	53217038030	30 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sertraline	Aidarex Pharmaceuticals LLC \| Aidarex Pharmaceuticals	2018-08-24	HUMAN PRESCRIPTION DRUG LABEL	1