Sertraline hydrochloride

Product NDC
50090-7395
11-digit product format
500907395
Labeler code
50090
Product ID
50090-7395_7e6058fe-fd67-4178-81db-fc63e88b573b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sertraline hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA078403
Marketing category
ANDA
Marketing start
2023-05-15
Substance
SERTRALINE HYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
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…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078403-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2008-01-08301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078403-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2008-01-08301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078403-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2008-01-081e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
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…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078403-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078403-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078403-001AB11e350fbaab3a…

Additional Listing Data#

Finished product
Yes
Brand name base
Sertraline hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SERTRALINE HYDROCHLORIDE25 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
312940Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4f6f2412-8085-45bf-be4f-63e44490a34eAvailable 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
50090-7395-0Sertraline hydrochloride30 in 1 BOTTLETABLET, FILM COATED301
50090-7395-1Sertraline hydrochloride90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7395-0EA - Each50090-7395636a6b2a-69d9-464d-97f5-df62cfd980d612024-12-10
50090-7395-1EA - Each50090-7395066dacd2-eab6-468a-92bd-b8838100bcbe12024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-7395SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]1Current NDC, 2 package rows20241027_4f6f2412-8085-45bf-be4f-63e44490a34e.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 · 13 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sertraline hydrochlorideSERTRALINE HYDROCHLORIDEREMEDYREPACK INC.9d49e2cb-a852-403d-b92b-e7d3fa88032c2026-07-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078403
application number: ANDA078403
Sertraline hydrochlorideSERTRALINE HYDROCHLORIDEREMEDYREPACK INC.e554537c-9469-4f9a-9157-d5763bb8b7202026-07-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078403
application number: ANDA078403
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 HYDROCHLORIDEREMEDYREPACK INC.455c8416-c878-4283-a42f-4df896870a4e2025-09-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078403
application number: ANDA078403
Sertraline hydrochlorideSERTRALINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.4da914d0-629e-4766-b57f-6119fa8283cf2025-09-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078403
application number: ANDA078403
Sertraline hydrochlorideSERTRALINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.1afd0016-d0ee-4e25-a1a4-b66f228e2f9c2025-09-18Boxed 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
ndc (product): 50090-7395

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312940sertraline HCl 25 MG Oral TabletPSN4f6f2412-8085-45bf-be4f-63e44490a34e1
312940sertraline 25 MG Oral TabletSCD4f6f2412-8085-45bf-be4f-63e44490a34e1
312940sertraline (as sertraline HCl) 25 MG Oral TabletSY4f6f2412-8085-45bf-be4f-63e44490a34e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-7395-05009073950030 TABLET, FILM COATED in 1 BOTTLE (50090-7395-0) 2024-10-23NoNoCurrent
50090-7395-15009073950190 TABLET, FILM COATED in 1 BOTTLE (50090-7395-1) 2024-10-23NoNoCurrent