NDC 0228-2722 - Sertraline Hydrochloride

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 0228-2722
Package NDCs from labels: 0228-2722-03, 0228-2722-09, 0228-2722-90
Manufacturer: Actavis Elizabeth LLC
Effective date: 2009-04-07
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Sertraline Hydrochloride - Actavis Elizabeth LLC	Actavis Elizabeth LLC	2009-04-07	HUMAN PRESCRIPTION DRUG LABELING

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0228-2722	SERTRALINE HYDROCHLORIDE TABLET [ACTAVIS ELIZABETH LLC]	1	Unmatched	20090626_A9A68BF7-9C81-4517-870A-E93BD0E4F45C.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Sertraline Hydrochloride	ACTIVE INGREDIENT	UTI8907Y6X	SERTRALINE HYDROCHLORIDE TABLET [ACTAVIS ELIZABETH LLC]	1
sertraline	ACTIVE MOIETY	QUC7NX6WMB	SERTRALINE HYDROCHLORIDE TABLET [ACTAVIS ELIZABETH LLC]	1
d&c red #27 phloxine aluminum lake	INACTIVE INGREDIENT		SERTRALINE HYDROCHLORIDE TABLET [ACTAVIS ELIZABETH LLC]	1
dibasic calcium phosphate dihydrate	INACTIVE INGREDIENT	O7TSZ97GEP	SERTRALINE HYDROCHLORIDE TABLET [ACTAVIS ELIZABETH LLC]	1
fd&c blue #1 brilliant blue fcf aluminum lake	INACTIVE INGREDIENT		SERTRALINE HYDROCHLORIDE TABLET [ACTAVIS ELIZABETH LLC]	1
fd&c red #40 allura red ac aluminum lake	INACTIVE INGREDIENT		SERTRALINE HYDROCHLORIDE TABLET [ACTAVIS ELIZABETH LLC]	1
fd&c yellow #6 aluminum lake	INACTIVE INGREDIENT		SERTRALINE HYDROCHLORIDE TABLET [ACTAVIS ELIZABETH LLC]	1
hypromellose	INACTIVE INGREDIENT	3NXW29V3WO	SERTRALINE HYDROCHLORIDE TABLET [ACTAVIS ELIZABETH LLC]	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	SERTRALINE HYDROCHLORIDE TABLET [ACTAVIS ELIZABETH LLC]	1
microcrystalline celluose	INACTIVE INGREDIENT		SERTRALINE HYDROCHLORIDE TABLET [ACTAVIS ELIZABETH LLC]	1
polydextrose	INACTIVE INGREDIENT	VH2XOU12IE	SERTRALINE HYDROCHLORIDE TABLET [ACTAVIS ELIZABETH LLC]	1
polyethylene glycol	INACTIVE INGREDIENT	3WJQ0SDW1A	SERTRALINE HYDROCHLORIDE TABLET [ACTAVIS ELIZABETH LLC]	1
sodium starch glycolate	INACTIVE INGREDIENT		SERTRALINE HYDROCHLORIDE TABLET [ACTAVIS ELIZABETH LLC]	1
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	SERTRALINE HYDROCHLORIDE TABLET [ACTAVIS ELIZABETH LLC]	1
triacetin	INACTIVE INGREDIENT	XHX3C3X673	SERTRALINE HYDROCHLORIDE TABLET [ACTAVIS ELIZABETH LLC]	1

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 6 of 6 · 101 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
26BD97A0-0B1F-D7B8-27C0-6104C79FFBC1			A9A68BF7-9C81-4517-870A-E93BD0E4F45C	2009-04-07	Boxed warning, Warnings, Adverse reactions	Exact identifier spl id: 26BD97A0-0B1F-D7B8-27C0-6104C79FFBC1 spl set id: A9A68BF7-9C81-4517-870A-E93BD0E4F45C

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.