FDA.reportPublic FDA data

NDC 70518-4307-01 - 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
70518-4307
Requested NDC
70518-4307-01
Package NDCs from labels
70518-4307-0, 70518-4307-1, 70518-4307-01
Manufacturer
REMEDYREPACK INC.
Effective date
2026-09-03
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Sertraline Hydrochloride - REMEDYREPACK INC.REMEDYREPACK INC.2026-09-03HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-4307-0Sertraline Hydrochloride30 in 1 BLISTER PACKTABLET302
70518-4307-1Sertraline Hydrochloride90 in 1 BOTTLE, PLASTICTABLET902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-4307SERTRALINE HYDROCHLORIDE TABLET [REMEDYREPACK INC.]2Current NDC, 2 package rows20250529_7d598f1a-6c76-458a-a155-7a6a0743a2d3.zip

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 92 of 123 · 2,455 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sertraline hydrochlorideSERTRALINE HYDROCHLORIDEA-S Medication Solutions4f6f2412-8085-45bf-be4f-63e44490a34e2024-10-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312940
unii: UTI8907Y6X
SertralineSERTRALINEA-S Medication Solutionse93391c9-db88-4fa5-b1d5-f6c6de78b31c2024-10-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312940
unii: UTI8907Y6X
Positive Light Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 44NHOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDERare Beauty, LLCcffbb6af-5a04-f58a-e053-2995a90a1ae22024-10-23WarningsExact identifier
unii: 15FIX9V2JP
Banana BoatTITANIUM DIOXIDE, ZINC OXIDEEdgewell Personal Care Brands, LLC441a46f0-ecda-4448-e054-00144ff88e882024-10-23WarningsExact identifier
unii: 15FIX9V2JP
Positive Light Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 28CHOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDERare Beauty, LLCcffb8219-7076-de64-e053-2a95a90a60362024-10-23WarningsExact identifier
unii: 15FIX9V2JP
Positive Light Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 10NHOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDERare Beauty, LLCcfee02eb-92f9-be12-e053-2a95a90a43372024-10-23WarningsExact identifier
unii: 15FIX9V2JP
CVS Health 60 Plus Sensitive Skin SunTITANIUM DIOXIDE, ZINC OXIDECVS Pharmacy477c25ec-33db-04a6-e054-00144ff8d46c2024-10-22WarningsExact identifier
unii: 15FIX9V2JP
MetoxALLIUM SATIVUM, BERBERIS VULGARIS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, ASCORBICUM ACIDUM, CYSTEINUM, L-METHIONINE, PHYTOLACCA DECANDRA, THYROIDINUM (SUIS), CARBOLICUM ACIDUM, FORMALINUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, BORON, ARSENICUM ALBUM, ALUMINUM METALLICUM, ANTIMONIUM CRUDUM, ARGENTUM METALLICUM, MERCURIUS SOLUBILIS, PLUMBUM METALLICUM, LANTHANUM METALLICUM, NIOBIUM METALLICUM, NIOBIUM,Deseret Biologicals, Inc.ddaedfad-c7d1-4aeb-a52e-dce5c1b45c922024-10-22WarningsExact identifier
unii: PQ6CK8PD0R
Bali Body Tinted Super Serum Natural SPF 30OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEBali Body Pty Ltdf5eeaf37-33f2-2c0c-e053-2a95a90abcc02024-10-21WarningsExact identifier
unii: 15FIX9V2JP
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEBryant Ranch Prepack9f1d5689-3bf1-431c-9ea2-9e37217ecf402024-10-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312938
unii: UTI8907Y6X
Fruit of the Earth Sun Town City Baby and Kids Mineral SPF 50 SunscreenTITANIUM DIOXIDE, ZINC OXIDEFruit Of The Earth, Inc.f42a0b1e-038d-4fab-e053-2995a90a53642024-10-18WarningsExact identifier
unii: 15FIX9V2JP
Fruit of the Earth Sun Town City Mineral SPF 30 SunscreenTITANIUM DIOXIDE, ZINC OXIDEFruit Of The Earth, Inc.f4481bf3-6dc7-5641-e053-2a95a90ad9382024-10-18WarningsExact identifier
unii: 15FIX9V2JP
Fruit of the Earth Sun Town City Mineral SPF 50 SunscreenTITANIUM DIOXIDE, ZINC OXIDEFruit Of The Earth, Inc.f45d25d2-9305-5858-e053-2a95a90a7f7b2024-10-18WarningsExact identifier
unii: 15FIX9V2JP
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEBryant Ranch Prepack4191b929-5bdb-4388-9e4d-fffce55bc3632024-10-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312941
unii: UTI8907Y6X
MetabolismBERBERIS VULGARIS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, RHAMNUS PURSHIANA, TRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, ASCORBICUM ACIDUM, METHYLCOBALAMIN, RIBOFLAVINUM, THIAMINUM HYDROCHLORICUM, GERMANIUM SESQUIOXIDE, CYSTEINUM, MANGANESE GLUCONATE, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-KETOGLUTARICUM ACIDUM, FUMARICUM ACIDUM, MAGNESIA PHOSPHORICA, NATRUM OXALACETICUM, PULSATILLA (VULGARIS), PYRUVIC ACID, UBIDECARENONUM, HEPAR SULPHURIS CALCAREUMBioActive Nutritional, Inc.76f70259-44b1-467a-bff4-b427ddfe3abd2024-10-17WarningsExact identifier
unii: PQ6CK8PD0R
SPF50 Plus Mineral SunscreenZINC OXIDE AND TITANIUM DIOXIDEKAS Direct LLC dba BabyGanics08e8bc10-85d8-4215-8351-7ec12029416c2024-10-17WarningsExact identifier
unii: 15FIX9V2JP
MINERAL SUNSCREEN SPF 50ZINC OXIDE, TITANIUM DIOXIDEWEGMANS FOOD MARKETS INCbfe24f55-d0e5-254a-e053-2995a90a2fd32024-10-16WarningsExact identifier
unii: 15FIX9V2JP
Equate Sunscreen SPF 50 KIDS Broad SpectrumTITANIUM DIOXIDE, ZINC OXIDEWAL-MART STORES INC81cb6b2e-1ca3-4a83-a8df-9bfee61e79af2024-10-16WarningsExact identifier
unii: 15FIX9V2JP
SertralineSERTRALINEA-S Medication Solutionsf5bf9595-d9f9-40b1-9b3b-da277fd5ab7f2024-10-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312938
unii: UTI8907Y6X
SertralineSERTRALINEA-S Medication Solutionsb2533b60-cc54-4905-a4ee-ea08a160f8c62024-10-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312938
unii: UTI8907Y6X

Reported adverse events (FAERS/openFDA)#

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