FDA.reportPublic FDA data

NDC 70518-4606-01 - 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
70518-4606
Requested NDC
70518-4606-01
Package NDCs from labels
70518-4606-1, 70518-4606-0, 70518-4606-01
Manufacturer
REMEDYREPACK INC.
Effective date
2026-04-23
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.2026-04-23HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-4606-0Sertraline Hydrochloride50 in 1 BOXTABLET, FILM COATED501
70518-4606-1Sertraline Hydrochloride1 in 1 POUCHTABLET, FILM COATED11

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 11 of 122 · 2,430 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Prenatal Plus VitaminsPRENATAL WITH FERROUS FUMARATE AND FOLIC ACIDREMEDYREPACK INC.1b8ef3ea-5563-48ef-ba5e-27e0b454efb92026-04-23Boxed warningExact identifier
unii: PQ6CK8PD0R
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEREMEDYREPACK INC.268bd7f7-bc17-4850-ab7c-1b73caa564d52026-04-23Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077670
ndc (package): 70518-4606-1
ndc (package): 70518-4606-0
ndc (product): 70518-4606
ndc11 (package): 70518460601
rxcui: 312940
spl id: 50209cd1-af86-53f4-e063-6394a90af9cf
spl set id: 268bd7f7-bc17-4850-ab7c-1b73caa564d5
unii: UTI8907Y6X
Johnsons Baby Mineral Sunscreen SPF 30TITANIUM DIOXIDE, ZINC OXIDEKenvue Brands LLC4fe04c4b-2751-0561-e063-6394a90af7682026-04-22WarningsExact identifier
unii: 15FIX9V2JP
Lazy Face SPF 30 FacescreenTITANIUM DIOXIDE, ZINC OXIDESunny Day Creations500ee303-7302-68d5-e063-6394a90ac6d42026-04-22WarningsExact identifier
unii: 15FIX9V2JP
VitaveraVITAVERAOncora Pharma, LLC058b1921-21da-49d9-b9c1-3f5636087aea2026-04-21Warnings, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
ELROEL Pang Pang Sun Cushion S7ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATEMONOGLOT HOLDINGS Inc.256bf56f-aefa-47ce-890c-5a3896c11b922026-04-17WarningsExact identifier
unii: 15FIX9V2JP
JUNGSAEMMOOL Essential Skin Nuder Cushion FairTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEJungsaemmool Beauty Co., Ltd.3a43c7c0-7468-4b7a-95b9-f03e37f1b49b2026-04-17WarningsExact identifier
unii: 15FIX9V2JP
JUNGSAEMMOOL Essential Skin Nuder Cushion Fair LightTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEJungsaemmool Beauty Co., Ltd.a251eb20-02e6-4b55-b969-c1bef2f9d7322026-04-17WarningsExact identifier
unii: 15FIX9V2JP
JUNGSAEMMOOL Essential Skin Nuder Cushion Fair PinkTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEJungsaemmool Beauty Co., Ltd.6684d69a-89ff-41e8-81f0-3e2367811a182026-04-17WarningsExact identifier
unii: 15FIX9V2JP
JUNGSAEMMOOL Essential Skin Nuder Cushion LightTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEJungsaemmool Beauty Co., Ltd.bf24d081-85f7-4a26-9416-ecff1fe59dec2026-04-17WarningsExact identifier
unii: 15FIX9V2JP
JUNGSAEMMOOL Essential Skin Nuder Cushion Pink LightTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEJungsaemmool Beauty Co., Ltd.4a09a01a-404f-4b67-91e0-666153f550e82026-04-17WarningsExact identifier
unii: 15FIX9V2JP
JUNGSAEMMOOL Essential Skin Nuder Cushion N-LightTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEJungsaemmool Beauty Co., Ltd.cf7c4445-0382-47ab-aba9-b40d63e4f1cc2026-04-17WarningsExact identifier
unii: 15FIX9V2JP
JUNGSAEMMOOL Essential Skin Nuder Cushion MediumTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEJungsaemmool Beauty Co., Ltd.80c60ffa-69e0-4b31-bd0d-fc8ff9936ba02026-04-17WarningsExact identifier
unii: 15FIX9V2JP
JUNGSAEMMOOL Essential Skin Nuder Cushion Medium DeepTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEJungsaemmool Beauty Co., Ltd.0e18d601-700a-4c1c-a434-22582253bd952026-04-17WarningsExact identifier
unii: 15FIX9V2JP
JUNGSAEMMOOL Essential Skin Nuder Cushion BronzeTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEJungsaemmool Beauty Co., Ltd.ddb3aa5e-cd1a-4792-b1b1-3604b368e0102026-04-17WarningsExact identifier
unii: 15FIX9V2JP
ChromagenFERROUS ASPARTO GLYCINATE, FERROUS FUMARATE, ASCORBIC ACID, FOLIC ACID, LEVOMEFOLATE GLUCOSAMINE, CYANOCOBALAMIN, ZINC, AND INTRINSIC FACTORAvion Pharmaceuticals, LLC13c5ed58-6333-498f-9ace-1049d7ae35522026-04-17Boxed warning, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
PRENATE DHAASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, DL-, FOLIC ACID, LEVOMEFOLATE CALCIUM, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, CALCIUM FORMATE, FERROUS ASPARTO GLYCINATE, MAGNESIUM OXIDE AND DOCONEXENTAvion Pharmaceuticals, LLC8f2eca71-9a82-4a19-9206-36a04b865fe12026-04-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20-DEEPYOUR NAME MINERAL SHEER TINTPML NYC, LLC0e246e64-2eab-1219-e063-6294a90a79a82026-04-17WarningsExact identifier
unii: 15FIX9V2JP
YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20-FAIR GLOWYOUR NAME MINERAL SHEER TINTPML NYC, LLC316cd8a3-3d62-83ac-e063-6394a90a4afa2026-04-17WarningsExact identifier
unii: 15FIX9V2JP
YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20- HONEY GLOWYOUR NAME MINERAL SHEER TINTPML NYC, LLC0e2424f4-0011-42b0-e063-6394a90a780d2026-04-17WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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