FDA.reportPublic FDA data

Sertraline HCl

Product NDC
69238-2791
11-digit product format
692382791
Labeler code
69238
Product ID
69238-2791_8d3cc874-a2eb-4977-862b-b09fdf66992a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sertraline
Dosage form
CAPSULE
Route
ORAL
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA219655
Marketing category
ANDA
Marketing start
2026-02-02
Substance
SERTRALINE HYDROCHLORIDE
Active strength
200 mg/1
Pharmacologic classes
Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A219655-001SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALAB2026-01-28
A219655-002SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEEQ 200MG BASECAPSULE / ORALAB2026-01-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A219655-001AB
A219655-002AB

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
2026-02-19 14:30 UTC2026-02A219655-001SERTRALINE HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALAB2026-01-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A219655-002SERTRALINE HYDROCHLORIDEEQ 200MG BASECAPSULE / ORALAB2026-01-28011fe1cb6892…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219655-001SERTRALINE HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALAB2026-01-28a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219655-002SERTRALINE HYDROCHLORIDEEQ 200MG BASECAPSULE / ORALAB2026-01-28a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A219655-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A219655-002AB1011fe1cb6892…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219655-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219655-002AB1a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
Sertraline HCl
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SERTRALINE HYDROCHLORIDE200 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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
251201Internal RxNorm lookup
410584Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
a5c49e6e-b8e0-4a75-99e6-b88e323ce653Available 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
69238-2791-1Sertraline HCl30 in 1 BOTTLECAPSULE302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69238-2791-1EA - Each69238-27910c71a9c0-5453-4046-af72-7dee904e214b12026-05-22

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sertraline HClSERTRALINEAmneal Pharmaceuticals NY LLCa5c49e6e-b8e0-4a75-99e6-b88e323ce6532026-01-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 219655
application number: ANDA219655
ndc (product): 69238-2791

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
410584sertraline 150 MG Oral CapsulePSNa5c49e6e-b8e0-4a75-99e6-b88e323ce6532
410584sertraline 150 MG Oral CapsuleSCDa5c49e6e-b8e0-4a75-99e6-b88e323ce6532
251201sertraline 200 MG Oral CapsuleSCDa5c49e6e-b8e0-4a75-99e6-b88e323ce6532
410584sertraline 150 MG (as sertraline HCl 168 MG) Oral CapsuleSYa5c49e6e-b8e0-4a75-99e6-b88e323ce6532
251201sertraline 200 MG (as sertraline HCl 224 MG) Oral CapsuleSYa5c49e6e-b8e0-4a75-99e6-b88e323ce6532

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69238-2791-16923827910130 CAPSULE in 1 BOTTLE (69238-2791-1) 30 capsule2026-02-02NoNoCurrent