FDA.reportPublic FDA data

Sertraline Hydrochloride

Product NDC
42337-201
11-digit product format
423370201
Labeler code
42337
Product ID
42337-201_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
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
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 6 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct42337-201IInactivated by FDA2026-07-31
excluded packagepackage42337-20142337-201-01IInactivated by FDA2026-07-31
excluded packagepackage42337-20142337-201-02IInactivated by FDA2026-07-31
excluded packagepackage42337-20142337-201-03IInactivated by FDA2026-07-31
excluded packagepackage42337-20142337-201-04IInactivated by FDA2026-07-31
excluded packagepackage42337-20142337-201-05IInactivated by FDA2026-07-31

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A076882-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2007-02-06a50c72e98297…
2026-08-01 22:54:322026-06A076882-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2007-02-06a50c72e98297…
2026-08-01 22:54:322026-06A076882-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2007-02-06a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A076882-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A076882-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A076882-003AB1a50c72e98297…

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42337-201-012024-01-30C16284748780-11030e365-36a7-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use SERTRALINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for SERTRALINE HYDROCHLORIDE TABLETS. SERTRALINE HYDROCHLORIDE TABLETS, for oral use Initial U.S. Approval: 1991
42337-201-022024-01-30C16284748780-11030e365-36a7-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use SERTRALINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for SERTRALINE HYDROCHLORIDE TABLETS. SERTRALINE HYDROCHLORIDE TABLETS, for oral use Initial U.S. Approval: 1991
42337-201-032024-01-30C16284748780-11030e365-36a7-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use SERTRALINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for SERTRALINE HYDROCHLORIDE TABLETS. SERTRALINE HYDROCHLORIDE TABLETS, for oral use Initial U.S. Approval: 1991
42337-201-042024-01-30C16284748780-11030e365-36a7-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use SERTRALINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for SERTRALINE HYDROCHLORIDE TABLETS. SERTRALINE HYDROCHLORIDE TABLETS, for oral use Initial U.S. Approval: 1991
42337-201-052024-01-30C16284748780-11030e365-36a7-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use SERTRALINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for SERTRALINE HYDROCHLORIDE TABLETS. SERTRALINE HYDROCHLORIDE TABLETS, for oral use Initial U.S. Approval: 1991

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42337-201-01Sertraline Hydrochloride30 in 1 BOTTLETABLET, FILM COATED301
42337-201-02Sertraline Hydrochloride60 in 1 BOTTLETABLET, FILM COATED601
42337-201-03Sertraline Hydrochloride90 in 1 BOTTLETABLET, FILM COATED901
42337-201-04Sertraline Hydrochloride180 in 1 BOTTLETABLET, FILM COATED1801
42337-201-05Sertraline Hydrochloride500 in 1 BOTTLETABLET, FILM COATED5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42337-201SERTRALINE 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
42337-201-014233702010130 TABLET, FILM COATED in 1 BOTTLE (42337-201-01) 2021-02-280000-00-00NoNoCurrent
42337-201-024233702010260 TABLET, FILM COATED in 1 BOTTLE (42337-201-02) 2021-02-280000-00-00NoNoCurrent
42337-201-034233702010390 TABLET, FILM COATED in 1 BOTTLE (42337-201-03) 2021-02-280000-00-00NoNoCurrent
42337-201-0442337020104180 TABLET, FILM COATED in 1 BOTTLE (42337-201-04) 2021-02-280000-00-00NoNoCurrent
42337-201-0542337020105500 TABLET, FILM COATED in 1 BOTTLE (42337-201-05) 2021-02-280000-00-00NoNoCurrent