Sertraline Hydrochloride

Product NDC
42337-202
Requested package NDC
42337-202-02
11-digit product format
423370202
Labeler code
42337
Product ID
42337-202_e8c17511-93ca-2cf2-e053-2a95a90a1dde
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sertraline hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Viwit Pharmaceutical Co., Ltd.
Application
ANDA076882
Marketing category
ANDA
Marketing start
2021-02-28
Marketing end
0000-00-00
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
2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage42337-20242337-202-02IInactivated by FDA2026-08-03

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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

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
A076882-001SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2007-02-06
A076882-002SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2007-02-06
A076882-003SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2007-02-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A076882-001AB
A076882-002AB
A076882-003AB

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 UTC2026-02A076882-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2007-02-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076882-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2007-02-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076882-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2007-02-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076882-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2007-02-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076882-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2007-02-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076882-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2007-02-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A076882-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2007-02-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076882-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2007-02-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076882-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2007-02-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076882-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2007-02-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076882-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2007-02-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076882-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2007-02-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076882-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2007-02-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076882-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2007-02-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076882-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2007-02-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076882-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2007-02-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076882-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2007-02-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076882-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2007-02-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076882-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2007-02-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076882-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2007-02-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076882-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2007-02-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076882-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2007-02-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076882-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2007-02-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076882-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2007-02-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076882-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2007-02-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076882-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2007-02-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076882-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2007-02-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076882-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2007-02-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A076882-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2007-02-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A076882-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2007-02-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076882-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2007-02-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076882-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2007-02-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076882-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2007-02-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076882-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2007-02-06301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076882-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2007-02-06301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076882-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2007-02-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076882-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2007-02-061e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076882-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2007-02-061e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076882-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2007-02-061e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076882-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2007-02-068072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A076882-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076882-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076882-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076882-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076882-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076882-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076882-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076882-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076882-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076882-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076882-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076882-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076882-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076882-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076882-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076882-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076882-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076882-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076882-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076882-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076882-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076882-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076882-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076882-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076882-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076882-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076882-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076882-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076882-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076882-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076882-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076882-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076882-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076882-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076882-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076882-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076882-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076882-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076882-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076882-001AB18072bd15b7f6…

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
42337-202-01Sertraline Hydrochloride30 in 1 BOTTLETABLET, FILM COATED301
42337-202-02Sertraline Hydrochloride60 in 1 BOTTLETABLET, FILM COATED601
42337-202-03Sertraline Hydrochloride90 in 1 BOTTLETABLET, FILM COATED901
42337-202-04Sertraline Hydrochloride180 in 1 BOTTLETABLET, FILM COATED1801
42337-202-05Sertraline Hydrochloride500 in 1 BOTTLETABLET, FILM COATED5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42337-202SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [VIWIT PHARMACEUTICAL CO., LTD.]1Legacy NDC, 5 package rows20220922_e8c184d1-d4a0-7777-e053-2995a90a51cc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312938sertraline HCl 100 MG Oral TabletPSNe8c184d1-d4a0-7777-e053-2995a90a51cc1
312940sertraline HCl 25 MG Oral TabletPSNe8c184d1-d4a0-7777-e053-2995a90a51cc1
312941sertraline HCl 50 MG Oral TabletPSNe8c184d1-d4a0-7777-e053-2995a90a51cc1
312938sertraline 100 MG Oral TabletSCDe8c184d1-d4a0-7777-e053-2995a90a51cc1
312940sertraline 25 MG Oral TabletSCDe8c184d1-d4a0-7777-e053-2995a90a51cc1
312941sertraline 50 MG Oral TabletSCDe8c184d1-d4a0-7777-e053-2995a90a51cc1
312938sertraline (as sertraline HCl) 100 MG Oral TabletSYe8c184d1-d4a0-7777-e053-2995a90a51cc1
312940sertraline (as sertraline HCl) 25 MG Oral TabletSYe8c184d1-d4a0-7777-e053-2995a90a51cc1
312941sertraline (as sertraline HCl) 50 MG Oral TabletSYe8c184d1-d4a0-7777-e053-2995a90a51cc1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42337-202-024233702020260 TABLET, FILM COATED in 1 BOTTLE (42337-202-02) 2021-02-280000-00-00NoNoCurrent