FDA.reportPublic FDA data

NDC 68533-057 - 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
68533-057
Package NDCs from labels
68533-057-12, 68533-057-25, 68533-057-40
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
LabelManufacturerEffective dateType
Sertraline Hydrochloride - Cobalt PharmaceuticalsCobalt Pharmaceuticals2007-08-02HUMAN PRESCRIPTION DRUG LABELING

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68533-057-12Sertraline Hydrochloride30 in 1 BOTTLETABLET, FILM COATED301
68533-057-25Sertraline Hydrochloride1000 in 1 BOTTLETABLET, FILM COATED10001
68533-057-40Sertraline Hydrochloride100 in 1 BOX, UNIT-DOSETABLET, FILM COATED1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68533-057SERTRALINE HYDROCHLORIDE (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [COBALT PHARMACEUTICALS]13 package rows20070824_C7AB46CD-B3A0-3F9E-97E6-E6125E1A52A2.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
sertraline hydrochlorideACTIVE INGREDIENTUTI8907Y6XSERTRALINE HYDROCHLORIDE (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [COBALT PHARMACEUTICALS]1
sertralineACTIVE MOIETYQUC7NX6WMBSERTRALINE HYDROCHLORIDE (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [COBALT PHARMACEUTICALS]1
dibasic calcium phosphate (anhydrous)INACTIVE INGREDIENTSERTRALINE HYDROCHLORIDE (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [COBALT PHARMACEUTICALS]1
macrogolINACTIVE INGREDIENTSERTRALINE HYDROCHLORIDE (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [COBALT PHARMACEUTICALS]1
magnesium stearateINACTIVE INGREDIENT70097M6I30SERTRALINE HYDROCHLORIDE (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [COBALT PHARMACEUTICALS]1
microcrystalline celluloseINACTIVE INGREDIENTSERTRALINE HYDROCHLORIDE (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [COBALT PHARMACEUTICALS]1
polyvinyl alcoholINACTIVE INGREDIENTSERTRALINE HYDROCHLORIDE (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [COBALT PHARMACEUTICALS]1
sodium starch glycolateINACTIVE INGREDIENTSERTRALINE HYDROCHLORIDE (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [COBALT PHARMACEUTICALS]1
talcINACTIVE INGREDIENT7SEV7J4R1USERTRALINE HYDROCHLORIDE (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [COBALT PHARMACEUTICALS]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPSERTRALINE 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 8 of 8 · 144 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEProficient Rx LP00179766-980b-44b0-99d3-1fee2bb27e372019-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312940
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEProficient Rx LP551d5946-00df-4608-96a2-b29f0ef93ba02019-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312941
SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEProficient Rx LP6b532e6a-b040-4a10-a242-fb6d8dfc08522019-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312938
rxcui: 312941
79C744CC-6DDA-1B6E-8B6F-E9CADC9A66F0C7AB46CD-B3A0-3F9E-97E6-E6125E1A52A22007-08-02Boxed warning, Warnings, Adverse reactionsExact identifier
spl id: 79C744CC-6DDA-1B6E-8B6F-E9CADC9A66F0
spl set id: C7AB46CD-B3A0-3F9E-97E6-E6125E1A52A2

Reported adverse events (FAERS/openFDA)#

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