Sertraline hydrochloride

Product NDC
70518-4157
11-digit product format
705184157
Labeler code
70518
Product ID
70518-4157_571e9bf8-75c2-b508-e063-6394a90a279f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sertraline hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA078403
Marketing category
ANDA
Marketing start
2024-08-13
Substance
SERTRALINE HYDROCHLORIDE
Active strength
50 mg/1
Pharmacologic classes
Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage70518-415770518-4157-0DDiscontinued by firm2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 1 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70518-415770518-4157-0DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A078403-001SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2008-01-08
A078403-002SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2008-01-08
A078403-003SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2008-01-08

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A078403-001AB
A078403-002AB
A078403-003AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A078403-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2008-01-0884e616aacf4f…
2026-09-14 22:38:342026-08A078403-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2008-01-0884e616aacf4f…
2026-09-14 22:38:342026-08A078403-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2008-01-0884e616aacf4f…
2026-08-18 06:07:402026-07A078403-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2008-01-08caaa826d4ba7…
2026-08-18 06:07:402026-07A078403-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2008-01-08caaa826d4ba7…
2026-08-18 06:07:402026-07A078403-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2008-01-08caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078403-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2008-01-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078403-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2008-01-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078403-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2008-01-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078403-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2008-01-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078403-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2008-01-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078403-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2008-01-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A078403-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2008-01-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078403-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2008-01-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078403-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2008-01-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078403-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2008-01-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078403-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2008-01-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078403-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2008-01-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078403-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2008-01-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078403-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2008-01-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078403-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2008-01-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078403-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2008-01-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078403-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2008-01-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078403-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2008-01-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078403-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2008-01-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078403-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2008-01-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078403-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2008-01-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078403-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2008-01-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078403-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2008-01-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078403-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2008-01-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078403-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2008-01-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078403-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2008-01-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078403-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2008-01-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078403-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2008-01-08d06236e962d9…
2024-10-29 15:01 UTC2024-10A078403-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2008-01-08d06236e962d9…
2024-10-29 15:01 UTC2024-10A078403-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2008-01-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078403-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2008-01-0879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078403-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2008-01-0879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078403-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2008-01-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078403-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2008-01-08301d65b070ca…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A078403-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A078403-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A078403-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A078403-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078403-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078403-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078403-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078403-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078403-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078403-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078403-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078403-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078403-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078403-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078403-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078403-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078403-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078403-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078403-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078403-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078403-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078403-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078403-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078403-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078403-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078403-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078403-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078403-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078403-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078403-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078403-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078403-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078403-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078403-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078403-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078403-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078403-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078403-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078403-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078403-001AB1301d65b070ca…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Sertraline hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SERTRALINE HYDROCHLORIDE50 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
UTI8907Y6XInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
312941Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9d49e2cb-a852-403d-b92b-e7d3fa88032cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4ac594ea-ad8b-47fd-9b52-bbd98301675eProduct name120220317
255fa467-900b-5557-4215-6823352d1150Product name220211028

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-4157-0Sertraline hydrochloride30 in 1 BOTTLE, PLASTICTABLET, FILM COATED305
70518-4157-1Sertraline hydrochloride90 in 1 BOTTLE, PLASTICTABLET, FILM COATED905

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-4157SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [REMEDYREPACK INC.]3Current NDC, 2 package rows20241212_9d49e2cb-a852-403d-b92b-e7d3fa88032c.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 1 of 1 · 12 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sertraline hydrochlorideSERTRALINE HYDROCHLORIDEREMEDYREPACK INC.455c8416-c878-4283-a42f-4df896870a4e2026-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078403
application number: ANDA078403
Sertraline hydrochlorideSERTRALINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.4da914d0-629e-4766-b57f-6119fa8283cf2026-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078403
application number: ANDA078403
Sertraline hydrochlorideSERTRALINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.1afd0016-d0ee-4e25-a1a4-b66f228e2f9c2026-08-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078403
application number: ANDA078403
Sertraline hydrochlorideSERTRALINE HYDROCHLORIDEREMEDYREPACK INC.9d49e2cb-a852-403d-b92b-e7d3fa88032c2026-07-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078403
application number: ANDA078403
ndc (product): 70518-4157
Sertraline hydrochlorideSERTRALINE HYDROCHLORIDEBryant Ranch Prepack9c0a7f78-9cac-4e82-b971-f3f9758f8a0c2026-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078403
application number: ANDA078403
Sertraline hydrochlorideSERTRALINE HYDROCHLORIDENorthwind Health Company, LLC4ddfd698-3d47-fc0e-e063-6394a90accec2026-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078403
application number: ANDA078403
Sertraline hydrochlorideSERTRALINE HYDROCHLORIDECoupler LLC544d1ed1-da06-976d-e063-6394a90afe792026-06-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078403
application number: ANDA078403
Sertraline hydrochlorideSERTRALINE HYDROCHLORIDEST. MARY'S MEDICAL PARK PHARMACY1fcd3f6d-a71f-b131-e063-6394a90a4b262026-05-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078403
application number: ANDA078403
Sertraline hydrochlorideSERTRALINE HYDROCHLORIDEGranules Pharmaceuticals Inc.98960cc1-1d44-4d89-b415-7e250cc762cc2026-04-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078403
application number: ANDA078403
Sertraline hydrochlorideSERTRALINE HYDROCHLORIDECoupler LLC2ce05049-030f-3e8b-e063-6394a90a48852025-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078403
application number: ANDA078403
Sertraline hydrochlorideSERTRALINE HYDROCHLORIDEA-S Medication Solutionsf705f743-40e9-42bf-88f5-6dd7e5d5ba942024-10-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078403
application number: ANDA078403
Sertraline hydrochlorideSERTRALINE HYDROCHLORIDEA-S Medication Solutions4f6f2412-8085-45bf-be4f-63e44490a34e2024-10-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078403
application number: ANDA078403

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312941sertraline HCl 50 MG Oral TabletPSN9d49e2cb-a852-403d-b92b-e7d3fa88032c5
312941sertraline 50 MG Oral TabletSCD9d49e2cb-a852-403d-b92b-e7d3fa88032c5
312941sertraline (as sertraline HCl) 50 MG Oral TabletSY9d49e2cb-a852-403d-b92b-e7d3fa88032c5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-4157-07051841570030 in 1 BOTTLE, PLASTICHistorical
70518-4157-17051841570190 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4157-1) 2024-09-18NoNoCurrent
70518-4157-270518415702100 POUCH in 1 BOX (70518-4157-2) / 1 TABLET, FILM COATED in 1 POUCH (70518-4157-3) 100 pouch2026-07-21NoNoCurrent