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 5 of 8 · 144 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SertralineSERTRALINEA-S Medication Solutionsad69cbfe-5b42-4714-a999-77d474e0849d2025-07-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312940
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEBryant Ranch Prepack50d0aef5-ecc7-49b0-964a-53f87058d22a2025-07-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312941
SERTRALINESERTRALINEAphena Pharma Solutions - Tennessee, LLC1548faf9-8625-f871-e063-6394a90a931f2025-07-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312941
SertralineSERTRALINEBryant Ranch Prepackc67bc43d-d341-47c6-8b81-a7ad4cdb12072025-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312940
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC30b94d67-0000-a045-e063-6394a90ade322025-03-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312938
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC680890b1-bc45-4f50-9aaf-e730ab515b852025-03-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312938
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEAsclemed USA, Inc.e25a13c3-a173-4cc3-99d3-0be43abbc4982025-02-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312938
rxcui: 312940
rxcui: 312941
SertralineSERTRALINENuCare Pharmaceuticals,Inc.0a1f7d44-c339-a4dd-e063-6294a90ac0de2025-02-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312938
Sertraline hydrochlorideSERTRALINE HYDROCHLORIDECoupler LLC2ce05049-030f-3e8b-e063-6394a90a48852025-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312941
SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEDIRECT RXab962a5a-fff6-2cf9-e053-2995a90ace0f2025-01-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312938
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.c4bad433-623b-402c-b454-d39f19a236272025-01-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312938
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.0e5a7b02-3972-47f0-9f49-e958d792beac2025-01-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312940
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.ae3be25b-2bde-4142-ad56-920a96ac8f392025-01-13Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312941
SertralineSERTRALINEBryant Ranch Prepacke0adb991-ec4e-4cd1-b54e-6d8c731a1d592025-01-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312938
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEAdvanced Rx Pharmacy of Tennessee, LLCec1b68d3-ff55-d0a2-e053-2a95a90a2e0b2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312941
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEAdvanced Rx Pharmacy of Tennessee, LLCf8c45a99-18ed-0e1f-e053-6394a90a2d522024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312938
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEQuality Care Products LLC25aef6c1-9964-44a1-a905-c37e5c28a3c02024-12-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312938
SertralineSERTRALINEQuality Care Products, LLC6ed2b9b7-e4af-4e28-a7d5-4ccb514af2172024-12-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312941
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEAmerican Health Packaging4e09f580-d612-416c-a4a4-79a4411845b22024-11-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312938
rxcui: 312940
rxcui: 312941
Sertraline hydrochlorideSERTRALINE HYDROCHLORIDEA-S Medication Solutionsf705f743-40e9-42bf-88f5-6dd7e5d5ba942024-10-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312940

Reported adverse events (FAERS/openFDA)#

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