FDA.reportPublic FDA data

NDC 16729-216-01 - 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
16729-216
Requested NDC
16729-216-01
Package NDCs from labels
16729-216-10, 16729-216-15, 16729-216-01, 16729-216-16, 16729-216-43
Manufacturer
PD-Rx Pharmaceuticals, Inc.
Effective date
2026-05-21
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
SERTRALINE HYDROCHLORIDE - PD-Rx Pharmaceuticals, Inc.PD-Rx Pharmaceuticals, Inc.2026-05-21HUMAN PRESCRIPTION DRUG LABEL
SERTRALINE HYDROCHLORIDE - Accord Healthcare, Inc. | Intas Pharmaceuticals LtdAccord Healthcare, Inc. | Intas Pharmaceuticals Ltd2025-12-17HUMAN PRESCRIPTION DRUG LABEL
SERTRALINE HYDROCHLORIDE - QPharma, Inc. | Northwind Health Company, LLCQPharma, Inc. | Northwind Health Company, LLC2025-12-15HUMAN PRESCRIPTION DRUG LABEL
SERTRALINE HYDROCHLORIDE - Quality Care Products, LLCQuality Care Products, LLC2024-12-18HUMAN PRESCRIPTION DRUG LABEL
SERTRALINE HYDROCHLORIDE - REMEDYREPACK INC.REMEDYREPACK INC.2024-09-24HUMAN PRESCRIPTION DRUG LABEL
SERTRALINE HYDROCHLORIDE - Preferred Pharmaceuticals Inc.Preferred Pharmaceuticals Inc.2024-08-07HUMAN PRESCRIPTION DRUG LABEL
SERTRALINE HYDROCHLORIDE - Bryant Ranch PrepackBryant Ranch Prepack2024-04-03HUMAN PRESCRIPTION DRUG LABEL
SERTRALINE HYDROCHLORIDE - RPK Pharmaceuticals, Inc.RPK Pharmaceuticals, Inc.2023-08-18HUMAN PRESCRIPTION DRUG LABEL
SERTRALINE HYDROCHLORIDE - RPK Pharmaceuticals, Inc.RPK Pharmaceuticals, Inc.2023-08-18HUMAN PRESCRIPTION DRUG LABEL
Sertraline Hydrochloride - Direct RxDirect Rx2023-01-12HUMAN PRESCRIPTION DRUG LABEL
SERTRALINE HYDROCHLORIDE - St. Mary's Medical Park PharmacySt. Mary's Medical Park Pharmacy2022-12-20HUMAN PRESCRIPTION DRUG LABEL
SERTRALINE HYDROCHLORIDE - A-S Medication SolutionsA-S Medication Solutions2022-04-13HUMAN PRESCRIPTION DRUG LABEL
SERTRALINE HYDROCHLORIDE - NuCare Pharmaceuticals,Inc.NuCare Pharmaceuticals,Inc.2021-08-06HUMAN PRESCRIPTION DRUG LABEL
SERTRALINE HYDROCHLORIDE - Unit Dose ServicesUnit Dose Services2021-05-20HUMAN PRESCRIPTION DRUG LABEL
Sertraline Hydrochloride Tablets USPNuCare Pharmaceuticals, Inc.2021-02-12HUMAN PRESCRIPTION DRUG LABEL
SERTRALINE HYDROCHLORIDE - Denton Pharma, Inc. DBA Northwind PharmaceuticalsDenton Pharma, Inc. DBA Northwind Pharmaceuticals2021-01-25HUMAN PRESCRIPTION DRUG LABEL
Sertraline Hydrochloride - Direct_RxDirect_Rx2021-01-07HUMAN PRESCRIPTION DRUG LABEL
SERTRALINE HYDROCHLORIDE - Proficient Rx LPProficient Rx LP2019-11-01HUMAN PRESCRIPTION DRUG LABEL
SERTRALINE HYDROCHLORIDE - Preferred Pharmaceuticals Inc.Preferred Pharmaceuticals Inc.2019-04-26HUMAN PRESCRIPTION DRUG LABEL
SERTRALINE HYDROCHLORIDE - DIRECT RXDIRECT RX2018-03-14HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16729-216-01SERTRALINE HYDROCHLORIDE100 in 1 BOTTLETABLET, FILM COATED10019
16729-216-10SERTRALINE HYDROCHLORIDE30 in 1 BOTTLETABLET, FILM COATED3019
16729-216-15SERTRALINE HYDROCHLORIDE90 in 1 BOTTLETABLET, FILM COATED9019
16729-216-16SERTRALINE HYDROCHLORIDE500 in 1 BOTTLETABLET, FILM COATED50019
16729-216-43SERTRALINE HYDROCHLORIDE100 in 1 BOX, UNIT-DOSETABLET, FILM COATED10019

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16729-216SERTRALINE 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
16729-216-15EA - Each16729-216244cfc50-a442-4123-bebc-3fe1dd4c1f7812017-03-06
16729-216-16EA - Each16729-21603832b5b-daa3-4a2f-90be-0c1e4075fed312017-03-06

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 3 of 117 · 2,335 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ESIKA COLORFIX POLVOS 32H POLVO COMPACTO FACIAL DE ALTA COBERTURA FPS 15 110-COCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEBEL STAR S.A.575fb2c3-e332-8a3b-e063-6394a90a9fd92026-07-24WarningsExact identifier
unii: 15FIX9V2JP
True Coast SPF 50 Mineral SunscreenZINC OXIDE 18%, TITANIUM DIOXIDE 6%Foshan Sugar Max Cosmetics CO.,Ltd5379466d-8d14-5fc2-e063-6394a90abd7e2026-07-22WarningsExact identifier
unii: 15FIX9V2JP
Droptics Dry Eye ReliefCARBOXYMETHYLCELLULOSE SODIUM,GLYCERIN,POLYSORBATE 80Droptics LLC29d7614b-f4b7-48e2-97c5-d1bff27731d22026-07-22WarningsExact identifier
unii: 6OZP39ZG8H
Sertraline hydrochlorideSERTRALINE HYDROCHLORIDEREMEDYREPACK INC.9d49e2cb-a852-403d-b92b-e7d3fa88032c2026-07-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312941
unii: UTI8907Y6X
Yves Saint Laurent All Hours Foundation Sunscreen Broad Spectrum SPF 30 Luminous Matte FoundationOCTINOXATE AND TITANIUM DIOXIDESICOS ET CIE571f23e9-1126-e32d-e063-6294a90a99512026-07-21WarningsExact identifier
unii: 15FIX9V2JP
MENS SPF50 ALL IN ONE SUNSCREENMENS SPF50 ALL IN ONE SUNSCREENLance (Guangzhou) Biological Technology Co., Ltd.57074480-77fd-cc06-e063-6294a90a28d42026-07-20WarningsExact identifier
unii: 15FIX9V2JP
Yves Saint Laurent All Hours Foundation Sunscreen Broad Spectrum SPF 30 Luminous Matte FoundationOCTINOXATE AND TITANIUM DIOXIDEL'Oreal USA Products Inc5711364c-f9b4-bfa6-e063-6294a90ace4a2026-07-20WarningsExact identifier
unii: 15FIX9V2JP
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.f6346a11-88b9-4425-b08d-a22f19c4ceb42026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312941
unii: UTI8907Y6X
SERTRALINESERTRALINE HYDROCHLORIDEA-S Medication Solutions7b5c29ff-25c8-4b68-844d-b8e95be7d09b2026-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312941
unii: UTI8907Y6X
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDECoupler LLC56442b06-c135-a035-e063-6394a90a171b2026-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312940
unii: UTI8907Y6X
Bombee Honey Daily Glow Shield SunscreenHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDEABT ASIA Inc.56112dff-b091-7a56-e063-6294a90a77d32026-07-08WarningsExact identifier
unii: 15FIX9V2JP
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEUnit Dose Solutions, Inc.561a8a20-be26-c4f8-e063-6394a90af0722026-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312938
unii: UTI8907Y6X
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEUnit Dose Solutions, Inc.561e7498-a606-366d-e063-6394a90a1c6a2026-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312941
unii: UTI8907Y6X
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30DERMIO DERMATOLOGY LLC562f5b0d-6a10-305d-e063-6394a90a59802026-07-08WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30Suzanne's Skin2soul LLC562fbaa6-f93a-5ec4-e063-6294a90a96342026-07-08WarningsExact identifier
unii: 15FIX9V2JP
Aussie Betta Tallow Sunscreen SPF50 SPF50TITANIUM DIOXIDE AND ZINC OXIDE SUNSCREENAUSSIE BETTA HEALTHY CARE PTY LTD56007d82-ff5b-6c26-e063-6294a90a09b62026-07-07WarningsExact identifier
unii: 15FIX9V2JP
EELHOE Body Coverage PerfectorTITANIUM DIOXIDEShantou Eelhoe Daily Chemical Technology Co., Ltd.5610c3b7-456b-3bc1-e063-6394a90a3fa82026-07-07WarningsExact identifier
unii: 15FIX9V2JP
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEUnit Dose Solutions, Inc.55f514c6-f6ec-13ac-e063-6294a90ac9572026-07-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312940
unii: UTI8907Y6X
Premier Tinted Mineral SunscreenBROAD SPECTRUM SPF30Emerald Aesthetics LLC55f88dd1-346c-22a5-e063-6294a90a711f2026-07-06WarningsExact identifier
unii: 15FIX9V2JP
OHUI Ultimate Cover CC Cushion Compact 02 Natural BeigeTITANIUM DIOXIDELG H&H Co., Ltd.d307471c-6cc6-ce48-e053-2995a90a3e022026-07-02WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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