Sertraline Hydrochloride

Product NDC: 45865-370
11-digit product format: 458650370
Labeler code: 45865
Product ID: 45865-370_71608ab4-18a0-f334-e053-2a95a90a17a7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sertraline Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Medsource Pharmaceuticals
Application: ANDA077397
Marketing category: ANDA
Marketing start: 2016-07-21
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: 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
45865-370-30	2020-01-31	C162847	48780-1	9d75b9cf-df91-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use SERTRALINE TABLETS safely and effectively. See full prescribing information for SERTRALINE TABLETS. SERTRALINE tablets, for oral use Initial U.S. Approval: 1991

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
45865-370-30	Sertraline Hydrochloride	30 in 1 BOTTLE	TABLET	30		1

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
45865-370	SERTRALINE HYDROCHLORIDE TABLET [MEDSOURCE PHARMACEUTICALS]	1	Legacy NDC, 1 package rows	20180720_71609f52-db58-3866-e053-2a95a90a0744.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
UTI8907Y6X	SERTRALINE HYDROCHLORIDE	79559-97-0	SERTRALINE HYDROCHLORIDE

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
312940	sertraline HCl 25 MG Oral Tablet	PSN	71609f52-db58-3866-e053-2a95a90a0744	1
312940	sertraline 25 MG Oral Tablet	SCD	71609f52-db58-3866-e053-2a95a90a0744	1
312940	sertraline (as sertraline HCl) 25 MG Oral Tablet	SY	71609f52-db58-3866-e053-2a95a90a0744	1

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
45865-370-30	45865037030	30 in 1 BOTTLE	Historical