Sertraline

Product NDC: 64725-0351
11-digit product format: 647250351
Labeler code: 64725
Product ID: 64725-0351_3d8002ca-2951-4a47-a101-754ceed78309
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sertraline
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: TYA Pharmaceuticals
Application: ANDA077670
Marketing category: ANDA
Marketing start: 2007-02-06
Marketing end: 0000-00-00
Substance: SERTRALINE HYDROCHLORIDE
Active strength: 25 mg/1
Pharmacologic classes: Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC exclude flag: E
Listing certified through: 2017-12-31
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
64725-0351-1	2019-11-27	C162847	48780-1	9855e2a2-3582-60a7-e053-dbdaa90a05bd	Sertraline Hydrochloride Tablets USP 25 mg, 50 mg and 100 mg Rx Only

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
64725-0351-1	Sertraline	30 in 1 BOTTLE	TABLET, FILM COATED	30		2

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SERTRALINE HYDROCHLORIDE	ACTIVE INGREDIENT	UTI8907Y6X	SERTRALINE TABLET, FILM COATED [TYA PHARMACEUTICALS]	2
SERTRALINE	ACTIVE MOIETY	QUC7NX6WMB	SERTRALINE TABLET, FILM COATED [TYA PHARMACEUTICALS]	2
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	INACTIVE INGREDIENT	L11K75P92J	SERTRALINE TABLET, FILM COATED [TYA PHARMACEUTICALS]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SERTRALINE TABLET, FILM COATED [TYA PHARMACEUTICALS]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	SERTRALINE TABLET, FILM COATED [TYA PHARMACEUTICALS]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	SERTRALINE TABLET, FILM COATED [TYA PHARMACEUTICALS]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	SERTRALINE TABLET, FILM COATED [TYA PHARMACEUTICALS]	2
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	SERTRALINE TABLET, FILM COATED [TYA PHARMACEUTICALS]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	SERTRALINE TABLET, FILM COATED [TYA PHARMACEUTICALS]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SERTRALINE TABLET, FILM COATED [TYA PHARMACEUTICALS]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	SERTRALINE TABLET, FILM COATED [TYA PHARMACEUTICALS]	2
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	SERTRALINE TABLET, FILM COATED [TYA PHARMACEUTICALS]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	SERTRALINE TABLET, FILM COATED [TYA PHARMACEUTICALS]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SERTRALINE TABLET, FILM COATED [TYA PHARMACEUTICALS]	2

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
64725-0351	SERTRALINE TABLET, FILM COATED [TYA PHARMACEUTICALS]	2	Legacy NDC, 1 package rows	20140828_3ee3a687-bbbf-4d17-8faf-33bc37328259.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
312940	sertraline HCl 25 MG Oral Tablet	PSN	3ee3a687-bbbf-4d17-8faf-33bc37328259	2
312940	sertraline 25 MG Oral Tablet	SCD	3ee3a687-bbbf-4d17-8faf-33bc37328259	2
312940	sertraline (as sertraline HCl) 25 MG Oral Tablet	SY	3ee3a687-bbbf-4d17-8faf-33bc37328259	2

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
64725-0351-1	64725035101	30 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sertraline Hydrochloride Tablets USP 25 mg, 50 mg and 100 mg Rx Only	TYA Pharmaceuticals	2014-08-01	HUMAN PRESCRIPTION DRUG LABEL	2