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 64 of 122 · 2,430 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.8f5a71b2-2821-46a0-ac65-28d9b2db73ec2025-10-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312940
unii: UTI8907Y6X
DD CreamDD CREAMDERMAdoctor, Inc.08c9a0cf-ee78-483b-e054-00144ff88e882025-10-16WarningsExact identifier
unii: 15FIX9V2JP
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
LumavexMULTIVITAMINOncora Pharma, LLC4139742d-d091-121c-e063-6394a90a62212025-10-15Warnings, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEA-S Medication Solutions0de9e3e3-912a-428b-89d2-70811a56cdc52025-10-15Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077670
rxcui: 312940
unii: UTI8907Y6X
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEA-S Medication Solutions1b069fd8-26b9-459e-abfb-de28c012ddcb2025-10-15Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077670
rxcui: 312938
unii: UTI8907Y6X
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEA-S Medication Solutionsa06f2cf6-ccef-47bf-aba8-a42bada46d8b2025-10-15Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077670
rxcui: 312940
unii: UTI8907Y6X
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEA-S Medication Solutions473d6055-b811-4ffb-9398-88f50a1521962025-10-15Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077670
rxcui: 312938
unii: UTI8907Y6X
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDELupin Pharmaceuticals, Inc.42120ff8-b353-4632-9ea9-54de9a6987242025-10-14Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077670
ndc (product): 68180-978
rxcui: 312938
rxcui: 312940
rxcui: 312941
spl id: 37fc8b27-bf23-4fe6-8d44-5331bde5b466
spl set id: 42120ff8-b353-4632-9ea9-54de9a698724
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
application number: ANDA077670
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

Reported adverse events (FAERS/openFDA)#

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