FDA.reportPublic FDA data

SERTRALINE HYDROCHLORIDE

Product NDC
71093-129
11-digit product format
710930129
Labeler code
71093
Product ID
71093-129_701d9091-1809-4afe-94af-f36fd04c174a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SERTRALINE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
ACI Healthcare USA, Inc.
Application
ANDA076881
Marketing category
ANDA
Marketing start
2007-02-06
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct71093-129IInactivated by FDA2026-07-31
excluded packagepackage71093-12971093-129-01IInactivated by FDA2026-07-31
excluded packagepackage71093-12971093-129-03IInactivated by FDA2026-07-31
excluded packagepackage71093-12971093-129-05IInactivated 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
A076881-001SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2007-02-06
A076881-002SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2007-02-06
A076881-003SERTRALINE 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
A076881-001AB
A076881-002AB
A076881-003AB

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 22:54:322026-06A076881-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2007-02-06a50c72e98297…
2026-08-01 22:54:322026-06A076881-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2007-02-06a50c72e98297…
2026-08-01 22:54:322026-06A076881-003SERTRALINE 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 22:54:322026-06A076881-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A076881-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A076881-003AB1a50c72e98297…

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
71093-129-01SERTRALINE HYDROCHLORIDE30 in 1 BOTTLE, PLASTICTABLET306
71093-129-03SERTRALINE HYDROCHLORIDE90 in 1 BOTTLE, PLASTICTABLET906
71093-129-05SERTRALINE HYDROCHLORIDE500 in 1 BOTTLE, PLASTICTABLET5006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71093-129-01EA - Each71093-129d81c115b-a045-4876-b85b-21430734fc3e12021-08-05
71093-129-03EA - Each71093-12900b83251-d0b7-4599-9209-39f98370f2be12021-08-05
71093-129-05EA - Each71093-1292a1860f6-4cec-4bd0-b8a0-7d4039395f4a12021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71093-129SERTRALINE HYDROCHLORIDE TABLET [ACI HEALTHCARE USA, INC.]6Legacy NDC, 3 package rows20230410_1f99e897-1b70-40b0-8c19-71d0bba19422.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312938sertraline HCl 100 MG Oral TabletPSN1f99e897-1b70-40b0-8c19-71d0bba194226
312940sertraline HCl 25 MG Oral TabletPSN1f99e897-1b70-40b0-8c19-71d0bba194226
312941sertraline HCl 50 MG Oral TabletPSN1f99e897-1b70-40b0-8c19-71d0bba194226
312938sertraline 100 MG Oral TabletSCD1f99e897-1b70-40b0-8c19-71d0bba194226
312940sertraline 25 MG Oral TabletSCD1f99e897-1b70-40b0-8c19-71d0bba194226
312941sertraline 50 MG Oral TabletSCD1f99e897-1b70-40b0-8c19-71d0bba194226
312938sertraline (as sertraline HCl) 100 MG Oral TabletSY1f99e897-1b70-40b0-8c19-71d0bba194226
312940sertraline (as sertraline HCl) 25 MG Oral TabletSY1f99e897-1b70-40b0-8c19-71d0bba194226
312941sertraline (as sertraline HCl) 50 MG Oral TabletSY1f99e897-1b70-40b0-8c19-71d0bba194226

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71093-129-017109301290130 TABLET in 1 BOTTLE, PLASTIC (71093-129-01) 30 tablet2018-08-200000-00-00NoNoCurrent
71093-129-037109301290390 TABLET in 1 BOTTLE, PLASTIC (71093-129-03) 90 tablet2018-08-200000-00-00NoNoCurrent
71093-129-0571093012905500 TABLET in 1 BOTTLE, PLASTIC (71093-129-05) 500 tablet2018-08-200000-00-00NoNoCurrent