Sertraline

Product NDC
23155-758
11-digit product format
231550758
Labeler code
23155
Product ID
23155-758_5079a5d2-af51-4bac-aaad-75653da2aa97
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sertraline
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application
ANDA076465
Marketing category
ANDA
Marketing start
2023-02-23
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
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A076465-001SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2006-08-11
A076465-002SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2006-08-11
A076465-003SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2006-08-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A076465-001AB
A076465-002AB
A076465-003AB

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 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A076465-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2006-08-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076465-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2006-08-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076465-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2006-08-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076465-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2006-08-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076465-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2006-08-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076465-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2006-08-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076465-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2006-08-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076465-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2006-08-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076465-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2006-08-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076465-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2006-08-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076465-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2006-08-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076465-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2006-08-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076465-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2006-08-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076465-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2006-08-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076465-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2006-08-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076465-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2006-08-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076465-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2006-08-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076465-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2006-08-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076465-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2006-08-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076465-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2006-08-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076465-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2006-08-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076465-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2006-08-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076465-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2006-08-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076465-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2006-08-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076465-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2006-08-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076465-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2006-08-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076465-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2006-08-11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076465-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2006-08-11d06236e962d9…
2024-10-29 15:01 UTC2024-10A076465-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2006-08-11d06236e962d9…
2024-10-29 15:01 UTC2024-10A076465-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2006-08-11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076465-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2006-08-1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076465-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2006-08-1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076465-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2006-08-1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076465-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2006-08-11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076465-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2006-08-11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076465-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2006-08-11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076465-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2006-08-111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076465-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2006-08-111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076465-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2006-08-111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076465-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2006-08-118072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 75 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A076465-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076465-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076465-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076465-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076465-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076465-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076465-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076465-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076465-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076465-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076465-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076465-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076465-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076465-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076465-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076465-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076465-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076465-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076465-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076465-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076465-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076465-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076465-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076465-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076465-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076465-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076465-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076465-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076465-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076465-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076465-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076465-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076465-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076465-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076465-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076465-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076465-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076465-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076465-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076465-001AB18072bd15b7f6…

Additional Listing Data#

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

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 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
312938Internal RxNorm lookup
312940Internal RxNorm lookup
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
444ca054-e450-4c10-a31b-71ad43946cb8Available 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
23155-758-03Sertraline30 in 1 BOTTLETABLET, FILM COATED305
23155-758-05Sertraline500 in 1 BOTTLETABLET, FILM COATED5005
23155-758-09Sertraline90 in 1 BOTTLETABLET, FILM COATED905
23155-758-69Sertraline5000 in 1 BOTTLETABLET, FILM COATED50005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23155-758-03EA - Each23155-758803a9dd0-67c6-4c7f-89eb-babd04a9d09112024-01-04
23155-758-05EA - Each23155-7586f03af76-e997-43fe-89a0-ca7dd6c7027e12024-01-04
23155-758-09EA - Each23155-7588ddd8211-08e2-4c8a-a3dc-613698ffc4cb12024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23155-758SERTRALINE TABLET, FILM COATED [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]4Current NDC, 4 package rows20240805_444ca054-e450-4c10-a31b-71ad43946cb8.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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SertralineSERTRALINESt. Mary's Medical Park Pharmacy3dd83384-09b5-da46-e063-6394a90a558c2026-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076465
application number: ANDA076465
SertralineSERTRALINEBryant Ranch Prepack03e1f274-fa9a-4461-b7c9-31ba6428c1072026-03-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076465
application number: ANDA076465
SertralineSERTRALINEA-S Medication Solutionse46bc887-69e2-4037-be59-6513277d157b2026-03-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076465
application number: ANDA076465
SertralineSERTRALINEREMEDYREPACK INC.7efc1dd5-8671-4bed-9c16-ef6b9f36afc42025-10-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076465
application number: ANDA076465
SertralineSERTRALINEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.444ca054-e450-4c10-a31b-71ad43946cb82025-09-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076465
application number: ANDA076465
ndc (product): 23155-758
SertralineSERTRALINEA-S Medication Solutionsad69cbfe-5b42-4714-a999-77d474e0849d2025-07-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076465
application number: ANDA076465
SertralineSERTRALINEBryant Ranch Prepackc67bc43d-d341-47c6-8b81-a7ad4cdb12072025-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076465
application number: ANDA076465
SertralineSERTRALINEBryant Ranch Prepacke0adb991-ec4e-4cd1-b54e-6d8c731a1d592025-01-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076465
application number: ANDA076465

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312938sertraline HCl 100 MG Oral TabletPSN444ca054-e450-4c10-a31b-71ad43946cb85
312940sertraline HCl 25 MG Oral TabletPSN444ca054-e450-4c10-a31b-71ad43946cb85
312941sertraline HCl 50 MG Oral TabletPSN444ca054-e450-4c10-a31b-71ad43946cb85
312938sertraline 100 MG Oral TabletSCD444ca054-e450-4c10-a31b-71ad43946cb85
312940sertraline 25 MG Oral TabletSCD444ca054-e450-4c10-a31b-71ad43946cb85
312941sertraline 50 MG Oral TabletSCD444ca054-e450-4c10-a31b-71ad43946cb85
312938sertraline (as sertraline HCl) 100 MG Oral TabletSY444ca054-e450-4c10-a31b-71ad43946cb85
312940sertraline (as sertraline HCl) 25 MG Oral TabletSY444ca054-e450-4c10-a31b-71ad43946cb85
312941sertraline (as sertraline HCl) 50 MG Oral TabletSY444ca054-e450-4c10-a31b-71ad43946cb85
312941sertraline HCl 50 MG Oral TabletPSN3dd83384-09b5-da46-e063-6394a90a558c1
312941sertraline 50 MG Oral TabletSCD3dd83384-09b5-da46-e063-6394a90a558c1
312941sertraline (as sertraline HCl) 50 MG Oral TabletSY3dd83384-09b5-da46-e063-6394a90a558c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
23155-758-032315507580330 TABLET, FILM COATED in 1 BOTTLE (23155-758-03) 2023-02-23NoNoCurrent
23155-758-0523155075805500 TABLET, FILM COATED in 1 BOTTLE (23155-758-05) 2023-02-23NoNoCurrent
23155-758-092315507580990 TABLET, FILM COATED in 1 BOTTLE (23155-758-09) 2023-02-23NoNoCurrent
23155-758-69231550758695000 TABLET, FILM COATED in 1 BOTTLE (23155-758-69) 2023-02-23NoNoCurrent