FDA.reportPublic FDA data

NDC 16729-217-01 - 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
16729-217
Requested NDC
16729-217-01
Package NDCs from labels
16729-217-10, 16729-217-15, 16729-217-01, 16729-217-16, 16729-217-43
Manufacturer
St. Mary's Medical Park Pharmacy
Effective date
2026-06-02
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
SERTRALINE HYDROCHLORIDE - St. Mary's Medical Park PharmacySt. Mary's Medical Park Pharmacy2026-06-02HUMAN PRESCRIPTION DRUG LABEL
SERTRALINE HYDROCHLORIDE - Bryant Ranch PrepackBryant Ranch Prepack2026-05-22HUMAN PRESCRIPTION DRUG LABEL
SERTRALINE HYDROCHLORIDE - Accord Healthcare, Inc. | Intas Pharmaceuticals LtdAccord Healthcare, Inc. | Intas Pharmaceuticals Ltd2025-12-17HUMAN PRESCRIPTION DRUG LABEL
SERTRALINE HYDROCHLORIDE - Preferred Pharmaceuticals Inc.Preferred Pharmaceuticals Inc.2025-09-19HUMAN PRESCRIPTION DRUG LABEL
SERTRALINE HYDROCHLORIDE - Quality Care Products, LLCQuality Care Products, LLC2024-12-18HUMAN PRESCRIPTION DRUG LABEL
SERTRALINE HYDROCHLORIDE - A-S Medication SolutionsA-S Medication Solutions2023-05-10HUMAN PRESCRIPTION DRUG LABEL
Sertraline Hydrochloride Tablets USPNuCare Pharmaceuticals,Inc.2022-07-05HUMAN PRESCRIPTION DRUG LABEL
SERTRALINE HYDROCHLORIDE - Aphena Pharma Solutions - Tennessee, LLCAphena Pharma Solutions - Tennessee, LLC2022-06-24HUMAN PRESCRIPTION DRUG LABEL
SERTRALINE HYDROCHLORIDE - RPK Pharmaceuticals, Inc.RPK Pharmaceuticals, Inc.2022-03-30HUMAN PRESCRIPTION DRUG LABEL
SERTRALINE HYDROCHLORIDE - REMEDYREPACK INC.REMEDYREPACK INC.2021-09-27HUMAN PRESCRIPTION DRUG LABEL
SERTRALINE HYDROCHLORIDE - Unit Dose ServicesUnit Dose Services2021-05-20HUMAN PRESCRIPTION DRUG LABEL
SERTRALINE HYDROCHLORIDE - Preferred Pharmaceuticals Inc.Preferred Pharmaceuticals Inc.2020-09-16HUMAN PRESCRIPTION DRUG LABEL
SERTRALINE HYDROCHLORIDE - Proficient Rx LPProficient Rx LP2019-11-01HUMAN PRESCRIPTION DRUG LABEL
Sertraline Hydrochloride Tablets USPNuCare Pharmaceuticals, Inc.2017-07-11HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16729-217-01SERTRALINE HYDROCHLORIDE100 in 1 BOTTLETABLET, FILM COATED10019
16729-217-10SERTRALINE HYDROCHLORIDE30 in 1 BOTTLETABLET, FILM COATED3019
16729-217-15SERTRALINE HYDROCHLORIDE90 in 1 BOTTLETABLET, FILM COATED9019
16729-217-16SERTRALINE HYDROCHLORIDE500 in 1 BOTTLETABLET, FILM COATED50019
16729-217-43SERTRALINE HYDROCHLORIDE100 in 1 BOX, UNIT-DOSETABLET, FILM COATED10019

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16729-217SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]17Current NDC, Legacy NDC, 5 package rows20240106_205ecf52-8138-44a7-ad9a-b3aa7f4fa11a.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16729-217-15EA - Each16729-217eb3a47d7-6880-4830-8c75-df42367fdf0912017-03-06
16729-217-16EA - Each16729-217cf3d11b6-fdea-49ef-94bc-bcd3a4bd91fd12017-03-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SERTRALINE HYDROCHLORIDEACTIVE INGREDIENTUTI8907Y6XSERTRALINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]2
SERTRALINEACTIVE MOIETYQUC7NX6WMBSERTRALINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]2
ANHYDROUS DIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENTL11K75P92JSERTRALINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USERTRALINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GSERTRALINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDSERTRALINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKSERTRALINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTSERTRALINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]2
HYDROXYPROPYL CELLULOSE (TYPE L)INACTIVE INGREDIENTUKE75GEA7FSERTRALINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]2
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]2
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQSERTRALINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HSERTRALINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSERTRALINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]2

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 61 of 115 · 2,292 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ciele Filter and ProtectTITANIUM DIOXIDE, ZINC OXIDECiele0309b0ef-baca-b41d-e063-6294a90a49d72025-10-15WarningsExact identifier
unii: 15FIX9V2JP
Defend and Balance TInted Mineral Sunscreen SPF 50SUNSCREENEpicuren Discovery41367f05-59d8-6736-e063-6394a90a5f172025-10-15WarningsExact identifier
unii: 15FIX9V2JP
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEA-S Medication Solutions0de9e3e3-912a-428b-89d2-70811a56cdc52025-10-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312940
unii: UTI8907Y6X
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEA-S Medication Solutions1b069fd8-26b9-459e-abfb-de28c012ddcb2025-10-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312938
unii: UTI8907Y6X
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEA-S Medication Solutionsa06f2cf6-ccef-47bf-aba8-a42bada46d8b2025-10-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312940
unii: UTI8907Y6X
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEA-S Medication Solutions473d6055-b811-4ffb-9398-88f50a1521962025-10-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312938
unii: UTI8907Y6X
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDELupin Pharmaceuticals, Inc.42120ff8-b353-4632-9ea9-54de9a6987242025-10-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312938
rxcui: 312940
rxcui: 312941
unii: UTI8907Y6X
SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEA-S Medication Solutions2bb3a2d1-76c4-42e6-8553-aa95f263175b2025-10-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312941
unii: UTI8907Y6X
SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEA-S Medication Solutionsc0cc1b03-ba35-4a2c-be95-2d9b7f4c34992025-10-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312938
unii: UTI8907Y6X
SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEA-S Medication Solutions50b54bfa-0b90-44f1-8f73-4f7f552449c42025-10-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312941
unii: UTI8907Y6X
SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEA-S Medication Solutions45af84f5-c284-4e82-ad3c-e9b7ab2b81142025-10-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312938
unii: UTI8907Y6X
Skinlycious Multi Protection Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE , ZINC OXIDESkinlycious Pte Ltde0ad02c3-f5ed-4b72-ba96-07d9c489a4ea2025-10-13WarningsExact identifier
unii: 15FIX9V2JP
Vertra S Dorian Kona Gold Signature Face Stick SPF 38TITANIUM DIOXIDEEai-jr 286, Incb6c316c3-661b-6428-e053-2a95a90a1a6b2025-10-10WarningsExact identifier
unii: 15FIX9V2JP
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.3ca30f3f-545e-46c5-b56a-73ec48e9647f2025-10-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312938
unii: UTI8907Y6X
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEAvPAK40be43b2-649b-0928-e063-6394a90a3b482025-10-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312938
rxcui: 312940
rxcui: 312941
unii: UTI8907Y6X
Dr Lift Mineral SPF 50TITANIUM DIOXIDE, ZINC OXIDESpa de Soleil40c03d65-8d09-371a-e063-6294a90a7ac62025-10-09WarningsExact identifier
unii: 15FIX9V2JP
Dr Lift Mineral SPF 30TITANIUM DIOXIDESpa de Soleil40c0e0d2-2c1d-e629-e063-6394a90a5aaf2025-10-09WarningsExact identifier
unii: 15FIX9V2JP
Essential Defense Mineral Shield Broad Spectrum SPF 35 SunscreenTITANIUM DIOXIDE AND ZINC OXIDEAllergan, Inc.29817fdc-f14c-4013-a8ed-4367f3b2867c2025-10-09WarningsExact identifier
unii: 15FIX9V2JP
Vertra Pearl White Face Stick SPF 50PADIMATE O, TITANIUM DIOXIDEEai-jr 286, Incb69a75e0-8724-35ae-e053-2a95a90a5f342025-10-07WarningsExact identifier
unii: 15FIX9V2JP
Vertra Mick Fanning Signature Foundation Sunscreen Face Stick SPF 35 Coolangatta BeigeTITANIUM DIOXIDEEAI-JR 286, Inc.b9ea12e8-6ed9-d805-e053-2a95a90aa1072025-10-07WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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