NDC 68533-056-25 - 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: 68533-056
Requested NDC: 68533-056-25
Package NDCs from labels: 68533-056-12, 68533-056-25, 68533-056-40
Manufacturer: Cobalt Pharmaceuticals
Effective date: 2007-08-02
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 - Cobalt Pharmaceuticals	Cobalt Pharmaceuticals	2007-08-02	HUMAN PRESCRIPTION DRUG LABELING

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68533-056-12	Sertraline Hydrochloride	30 in 1 BOTTLE	TABLET, FILM COATED	30	1
68533-056-25	Sertraline Hydrochloride	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	1
68533-056-40	Sertraline Hydrochloride	100 in 1 BOX, UNIT-DOSE	TABLET, FILM COATED	100	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68533-056	SERTRALINE HYDROCHLORIDE (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [COBALT PHARMACEUTICALS]	1	3 package rows	20070824_C7AB46CD-B3A0-3F9E-97E6-E6125E1A52A2.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
sertraline hydrochloride	ACTIVE INGREDIENT	UTI8907Y6X	SERTRALINE HYDROCHLORIDE (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [COBALT PHARMACEUTICALS]	1
sertraline	ACTIVE MOIETY	QUC7NX6WMB	SERTRALINE HYDROCHLORIDE (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [COBALT PHARMACEUTICALS]	1
dibasic calcium phosphate (anhydrous)	INACTIVE INGREDIENT		SERTRALINE HYDROCHLORIDE (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [COBALT PHARMACEUTICALS]	1
macrogol	INACTIVE INGREDIENT		SERTRALINE HYDROCHLORIDE (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [COBALT PHARMACEUTICALS]	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	SERTRALINE HYDROCHLORIDE (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [COBALT PHARMACEUTICALS]	1
microcrystalline cellulose	INACTIVE INGREDIENT		SERTRALINE HYDROCHLORIDE (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [COBALT PHARMACEUTICALS]	1
polyvinyl alcohol	INACTIVE INGREDIENT		SERTRALINE HYDROCHLORIDE (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [COBALT PHARMACEUTICALS]	1
sodium starch glycolate	INACTIVE INGREDIENT		SERTRALINE HYDROCHLORIDE (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [COBALT PHARMACEUTICALS]	1
talc	INACTIVE INGREDIENT	7SEV7J4R1U	SERTRALINE HYDROCHLORIDE (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [COBALT PHARMACEUTICALS]	1
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	SERTRALINE HYDROCHLORIDE (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [COBALT PHARMACEUTICALS]	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 8 · 146 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.	677c90cd-6527-40cb-a564-571796513fcb	2026-08-28	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 312938
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: 312938 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	PD-Rx Pharmaceuticals, Inc.	52c88667-c67e-4d42-b319-afb354713b1e	2026-08-07	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 312938
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Proficient Rx LP	9dacf5b7-1a23-4767-a074-11f26623e48b	2026-08-01	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 312938
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.	a2f333af-d37b-4705-ab7a-d363e3186e6e	2026-07-24	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 312938
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.	561a8a20-be26-c4f8-e063-6394a90af072	2026-07-08	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 312938
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

Reported adverse events (FAERS/openFDA)#

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