NDC 0228-2721-09 - 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: 0228-2721
Requested NDC: 0228-2721-09
Package NDCs from labels: 0228-2721-03, 0228-2721-09, 0228-2721-50
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
0228-2721	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 1 of 6 · 101 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	REMEDYREPACK INC.	7d598f1a-6c76-458a-a155-7a6a0743a2d3	2026-09-03	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 312940
Sertraline hydrochloride	SERTRALINE HYDROCHLORIDE	REMEDYREPACK INC.	455c8416-c878-4283-a42f-4df896870a4e	2026-08-28	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 312940
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	b559c20d-70be-41e7-acfb-262ffc3ea878	2026-08-28	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 312940
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	5921f77f-01a2-40b9-ad77-2258865c997d	2026-08-28	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 312941
Sertraline hydrochloride	SERTRALINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	4da914d0-629e-4766-b57f-6119fa8283cf	2026-08-28	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 312941
Sertraline hydrochloride	SERTRALINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	1afd0016-d0ee-4e25-a1a4-b66f228e2f9c	2026-08-27	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 312940
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Cardinal Health 107, LLC	7e5e76cf-2fda-4f9d-bcbf-f77b1f188ee6	2026-08-25	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 312941
Sertraline	SERTRALINE	Preferred Pharmaceuticals Inc.	957ba196-0b9b-4cda-bd15-28357ced8d2f	2026-08-20	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 312940
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	adfcc867-1b6e-4698-94b6-2b4190c4ba3d	2026-08-07	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 312941
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	REMEDYREPACK INC.	91e24d17-ff0a-449c-9472-b9df74c98456	2026-07-29	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 312941
Sertraline hydrochloride	SERTRALINE HYDROCHLORIDE	REMEDYREPACK INC.	9d49e2cb-a852-403d-b92b-e7d3fa88032c	2026-07-21	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 312941
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	f6346a11-88b9-4425-b08d-a22f19c4ceb4	2026-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 312941
SERTRALINE	SERTRALINE HYDROCHLORIDE	A-S Medication Solutions	7b5c29ff-25c8-4b68-844d-b8e95be7d09b	2026-07-14	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 312941
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Coupler LLC	56442b06-c135-a035-e063-6394a90a171b	2026-07-10	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 312940
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Unit Dose Solutions, Inc.	561e7498-a606-366d-e063-6394a90a1c6a	2026-07-08	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 312941
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Unit Dose Solutions, Inc.	55f514c6-f6ec-13ac-e063-6294a90ac957	2026-07-06	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 312940
Sertraline	SERTRALINE	St. Mary's Medical Park Pharmacy	3dd83384-09b5-da46-e063-6394a90a558c	2026-06-30	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 312941
Sertraline hydrochloride	SERTRALINE HYDROCHLORIDE	Bryant Ranch Prepack	9c0a7f78-9cac-4e82-b971-f3f9758f8a0c	2026-06-25	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 312940
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	REMEDYREPACK INC.	575da603-b038-421f-9894-6796d9ac33cc	2026-06-25	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 312940
Sertraline hydrochloride	SERTRALINE HYDROCHLORIDE	Northwind Health Company, LLC	4ddfd698-3d47-fc0e-e063-6394a90accec	2026-06-23	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 312941

Reported adverse events (FAERS/openFDA)#

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