Sertraline

Product NDC
71335-2659
11-digit product format
713352659
Labeler code
71335
Product ID
71335-2659_5e3634b1-0d8b-4e23-9dd7-ec4fc3826b65
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sertraline
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA076465
Marketing category
ANDA
Marketing start
2023-02-23
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
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 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A076465-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2006-08-11caaa826d4ba7…
2026-08-18 06:07:402026-07A076465-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2006-08-11caaa826d4ba7…
2026-08-18 06:07:402026-07A076465-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2006-08-11caaa826d4ba7…
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…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 78 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A076465-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A076465-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A076465-003AB1caaa826d4ba7…
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…

Additional Listing Data#

Finished product
Yes
Brand name base
Sertraline
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
c67bc43d-d341-47c6-8b81-a7ad4cdb1207Available 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
71335-2659-1Sertraline30 in 1 BOTTLETABLET, FILM COATED301
71335-2659-2Sertraline60 in 1 BOTTLETABLET, FILM COATED601
71335-2659-3Sertraline90 in 1 BOTTLETABLET, FILM COATED901
71335-2659-4Sertraline180 in 1 BOTTLETABLET, FILM COATED1801
71335-2659-5Sertraline28 in 1 BOTTLETABLET, FILM COATED281
71335-2659-6Sertraline120 in 1 BOTTLETABLET, FILM COATED1201
71335-2659-7Sertraline100 in 1 BOTTLETABLET, FILM COATED1001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2659-1EA - Each71335-26593b1b854c-33ef-4a8b-b248-41e2b859321c12026-04-20
71335-2659-2EA - Each71335-2659ffa3c087-d382-4d9d-9003-fb7a0162aebb12026-04-20
71335-2659-3EA - Each71335-2659fcc0463d-e734-4652-8ba9-1cb4888579fb12026-04-20
71335-2659-4EA - Each71335-2659a4df8748-36dd-4618-88b7-abf214d0d4ba12026-04-20
71335-2659-5EA - Each71335-265973a3675d-8fdc-424a-9da2-1983f766a94812026-04-20
71335-2659-6EA - Each71335-26594d613c1f-393a-49fe-94c3-eedd10666bdc12026-04-20
71335-2659-7EA - Each71335-2659c79d4bdd-d1c1-4b1e-a245-b9efbd125b7f12026-04-20

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 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SertralineSERTRALINEPreferred Pharmaceuticals Inc.957ba196-0b9b-4cda-bd15-28357ced8d2f2026-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076465
application number: ANDA076465
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
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
ndc (product): 71335-2659
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
312940sertraline HCl 25 MG Oral TabletPSNc67bc43d-d341-47c6-8b81-a7ad4cdb12071
312940sertraline 25 MG Oral TabletSCDc67bc43d-d341-47c6-8b81-a7ad4cdb12071
312940sertraline (as sertraline HCl) 25 MG Oral TabletSYc67bc43d-d341-47c6-8b81-a7ad4cdb12071

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-2659-17133526590130 TABLET, FILM COATED in 1 BOTTLE (71335-2659-1) 2025-06-23NoNoCurrent
71335-2659-27133526590260 TABLET, FILM COATED in 1 BOTTLE (71335-2659-2) 2025-06-23NoNoCurrent
71335-2659-37133526590390 TABLET, FILM COATED in 1 BOTTLE (71335-2659-3) 2025-06-23NoNoCurrent
71335-2659-471335265904180 TABLET, FILM COATED in 1 BOTTLE (71335-2659-4) 2025-06-23NoNoCurrent
71335-2659-57133526590528 TABLET, FILM COATED in 1 BOTTLE (71335-2659-5) 2025-06-23NoNoCurrent
71335-2659-671335265906120 TABLET, FILM COATED in 1 BOTTLE (71335-2659-6) 2025-06-23NoNoCurrent
71335-2659-771335265907100 TABLET, FILM COATED in 1 BOTTLE (71335-2659-7) 2025-06-23NoNoCurrent