Sertraline

Product NDC
64205-965
11-digit product format
642050965
Labeler code
64205
Product ID
64205-965_52b33a33-da21-4d86-aa55-393db4046b28
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sertraline hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
ReadyMeds
Application
ANDA077864
Marketing category
ANDA
Marketing start
2012-11-06
Marketing end
0000-00-00
Substance
SERTRALINE HYDROCHLORIDE
Active strength
50 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct64205-965IInactivated by FDA2026-08-17
excluded packagepackage64205-96564205-965-30IInactivated by FDA2026-08-17
excluded packagepackage64205-96564205-965-90IInactivated by FDA2026-08-17

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 2 · 66 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage64205-965-90d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage64205-965-30d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage64205-965-90f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage64205-965-30f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage64205-965-902ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage64205-965-302ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage64205-965-90a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage64205-965-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage64205-965-90cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage64205-965-30cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage64205-965-90cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage64205-965-30cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage64205-965-90302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage64205-965-30302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage64205-965-90ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage64205-965-30ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage64205-965-900efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage64205-965-300efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage64205-965-90ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage64205-965-30ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage64205-965-90367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage64205-965-30367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage64205-965-90557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage64205-965-30557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage64205-965-908af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage64205-965-308af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage64205-965-90834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage64205-965-30834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage64205-965-901332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage64205-965-301332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage64205-965-90fb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage64205-965-30fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage64205-965-9086f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage64205-965-3086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage64205-965-90bd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage64205-965-30bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage64205-965-908dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage64205-965-308dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage64205-965-90e2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage64205-965-30e2bbac7714bc…27bdfed8d636…

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
A077864-001SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORAL2009-08-10
A077864-002SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORAL2009-08-10
A077864-003SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORAL2009-08-10

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 06:07:402026-07A077864-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORAL2009-08-10caaa826d4ba7…
2026-08-18 06:07:402026-07A077864-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORAL2009-08-10caaa826d4ba7…
2026-08-18 06:07:402026-07A077864-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORAL2009-08-10caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077864-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORAL2009-08-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077864-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORAL2009-08-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077864-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORAL2009-08-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077864-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORAL2009-08-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077864-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORAL2009-08-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077864-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORAL2009-08-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A077864-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORAL2009-08-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077864-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORAL2009-08-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077864-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORAL2009-08-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077864-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORAL2009-08-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077864-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORAL2009-08-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077864-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORAL2009-08-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077864-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORAL2009-08-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077864-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORAL2009-08-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077864-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORAL2009-08-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077864-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORAL2009-08-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077864-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORAL2009-08-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077864-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORAL2009-08-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077864-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORAL2009-08-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077864-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORAL2009-08-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077864-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORAL2009-08-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077864-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORAL2009-08-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077864-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORAL2009-08-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077864-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORAL2009-08-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077864-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORAL2009-08-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077864-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORAL2009-08-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077864-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORAL2009-08-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077864-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORAL2009-08-10d06236e962d9…
2024-10-29 15:01 UTC2024-10A077864-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORAL2009-08-10d06236e962d9…
2024-10-29 15:01 UTC2024-10A077864-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORAL2009-08-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077864-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORAL2009-08-1079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077864-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORAL2009-08-1079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077864-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORAL2009-08-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077864-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORAL2009-08-10301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077864-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORAL2009-08-10301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077864-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORAL2009-08-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077864-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORAL2009-08-101e350fbaab3a…

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64205-965-30Sertraline30 in 1 BOTTLETABLET, FILM COATED303
64205-965-90Sertraline90 in 1 BOTTLETABLET, FILM COATED903

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SERTRALINE HYDROCHLORIDEACTIVE INGREDIENTUTI8907Y6XSERTRALINE (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [READYMEDS]3
SERTRALINEACTIVE MOIETYQUC7NX6WMBSERTRALINE (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [READYMEDS]3
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPSERTRALINE (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [READYMEDS]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USERTRALINE (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [READYMEDS]3
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKSERTRALINE (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [READYMEDS]3
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PSERTRALINE (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [READYMEDS]3
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6SERTRALINE (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [READYMEDS]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SERTRALINE (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [READYMEDS]3
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQSERTRALINE (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [READYMEDS]3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HSERTRALINE (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [READYMEDS]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2SERTRALINE (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [READYMEDS]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSERTRALINE (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [READYMEDS]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64205-965SERTRALINE (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [READYMEDS]3Legacy NDC, 2 package rows20140515_97f320c5-aa0b-43a8-85e8-c277a5929d97.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312941sertraline HCl 50 MG Oral TabletPSN97f320c5-aa0b-43a8-85e8-c277a5929d973
312941sertraline 50 MG Oral TabletSCD97f320c5-aa0b-43a8-85e8-c277a5929d973
312941sertraline (as sertraline HCl) 50 MG Oral TabletSY97f320c5-aa0b-43a8-85e8-c277a5929d973

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
64205-965-306420509653030 in 1 BOTTLEHistorical
64205-965-906420509659090 in 1 BOTTLEHistorical