SERTRALINE HYDROCHLORIDE

Product NDC
72865-207
11-digit product format
728650207
Labeler code
72865
Product ID
72865-207_918e3fe6-8b38-4ec8-accb-09b2d82ff404
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sertraline hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
XLCare Pharmaceuticals, Inc.
Application
ANDA214790
Marketing category
ANDA
Marketing start
2021-05-03
Substance
SERTRALINE HYDROCHLORIDE
Active strength
100 mg/1
Pharmacologic classes
Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A214790-001SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2021-05-03
A214790-002SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2021-05-03
A214790-003SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2021-05-03
A214790-004SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEEQ 75MG BASETABLET / ORALRS2026-08-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A214790-001AB
A214790-002AB
A214790-003AB

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 3 · 103 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A214790-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2021-05-03caaa826d4ba7…
2026-08-18 06:07:402026-07A214790-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2021-05-03caaa826d4ba7…
2026-08-18 06:07:402026-07A214790-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2021-05-03caaa826d4ba7…
2026-08-18 06:07:402026-07A214790-004SERTRALINE HYDROCHLORIDEEQ 75MG BASETABLET / ORALRS2026-08-10caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A214790-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2021-05-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214790-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2021-05-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214790-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2021-05-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214790-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2021-05-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214790-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2021-05-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214790-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2021-05-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08A214790-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2021-05-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214790-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2021-05-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214790-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2021-05-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214790-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2021-05-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214790-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2021-05-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214790-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2021-05-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214790-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2021-05-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214790-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2021-05-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214790-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2021-05-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214790-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2021-05-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214790-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2021-05-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214790-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2021-05-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214790-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2021-05-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214790-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2021-05-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214790-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2021-05-032680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214790-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2021-05-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214790-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2021-05-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214790-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2021-05-035bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214790-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2021-05-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214790-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2021-05-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214790-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2021-05-03d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214790-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2021-05-03d06236e962d9…
2024-10-29 15:01 UTC2024-10A214790-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2021-05-03d06236e962d9…
2024-10-29 15:01 UTC2024-10A214790-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2021-05-03d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214790-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2021-05-0379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214790-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2021-05-0379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214790-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2021-05-0379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214790-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2021-05-03301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214790-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2021-05-03301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214790-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2021-05-03301d65b070ca…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 102 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A214790-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A214790-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A214790-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A214790-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214790-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214790-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214790-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214790-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214790-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A214790-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214790-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214790-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214790-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214790-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214790-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214790-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214790-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214790-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214790-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214790-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214790-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214790-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214790-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214790-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214790-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214790-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214790-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214790-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214790-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214790-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214790-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A214790-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A214790-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214790-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214790-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214790-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214790-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214790-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214790-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214790-001AB11e350fbaab3a…

Additional Listing Data#

Finished product
Yes
Brand name base
SERTRALINE HYDROCHLORIDE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SERTRALINE HYDROCHLORIDE100 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 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
312938Internal RxNorm lookup
312940Internal RxNorm lookup
312941Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
5b73a90e-b883-419b-b30f-a379eed764d9Available 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
72865-207-05SERTRALINE HYDROCHLORIDE500 in 1 BOTTLETABLET5003
72865-207-18SERTRALINE HYDROCHLORIDE180 in 1 BOTTLETABLET1803
72865-207-30SERTRALINE HYDROCHLORIDE30 in 1 BOTTLETABLET303
72865-207-90SERTRALINE HYDROCHLORIDE90 in 1 BOTTLETABLET903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72865-207-05EA - Each72865-2071070bb89-66a5-4eba-a909-8caf5e7fec9f12022-02-07
72865-207-18EA - Each72865-207a0f87c01-5865-4f48-9428-a70734db103512022-02-07
72865-207-30EA - Each72865-207535e03f8-3676-470e-b875-365c7743689e12022-02-07
72865-207-90EA - Each72865-207bd29a974-7614-43dc-bf6b-fd45b5fad68d12022-02-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72865-207SERTRALINE HYDROCHLORIDE TABLET [XLCARE PHARMACEUTICALS, INC.]3Current NDC, Legacy NDC, 4 package rows20230928_5b73a90e-b883-419b-b30f-a379eed764d9.zip

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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDENuCare Pharmaceuticals, Inc.48702ef4-21cd-754e-e063-6394a90af24e2026-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214790
application number: ANDA214790
SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEA-S Medication Solutions2bb3a2d1-76c4-42e6-8553-aa95f263175b2025-10-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214790
application number: ANDA214790
SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEA-S Medication Solutionsc0cc1b03-ba35-4a2c-be95-2d9b7f4c34992025-10-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214790
application number: ANDA214790
SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEA-S Medication Solutions50b54bfa-0b90-44f1-8f73-4f7f552449c42025-10-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214790
application number: ANDA214790
SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEA-S Medication Solutions45af84f5-c284-4e82-ad3c-e9b7ab2b81142025-10-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214790
application number: ANDA214790
SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDECamber Pharmaceuticals, Inc.de1f85ac-df1b-4b7b-8e18-48ebdc8b92792024-09-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214790
application number: ANDA214790
SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEXLCare Pharmaceuticals, Inc.5b73a90e-b883-419b-b30f-a379eed764d92023-06-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214790
application number: ANDA214790
ndc (product): 72865-207
SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEAscent Pharmaceuticals, Inc.056191ca-999a-4c9b-93b9-64db44b8e6282021-05-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214790
application number: ANDA214790

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312938sertraline HCl 100 MG Oral TabletPSN5b73a90e-b883-419b-b30f-a379eed764d93
312940sertraline HCl 25 MG Oral TabletPSN5b73a90e-b883-419b-b30f-a379eed764d93
312941sertraline HCl 50 MG Oral TabletPSN5b73a90e-b883-419b-b30f-a379eed764d93
312938sertraline 100 MG Oral TabletSCD5b73a90e-b883-419b-b30f-a379eed764d93
312940sertraline 25 MG Oral TabletSCD5b73a90e-b883-419b-b30f-a379eed764d93
312941sertraline 50 MG Oral TabletSCD5b73a90e-b883-419b-b30f-a379eed764d93
312938sertraline (as sertraline HCl) 100 MG Oral TabletSY5b73a90e-b883-419b-b30f-a379eed764d93
312940sertraline (as sertraline HCl) 25 MG Oral TabletSY5b73a90e-b883-419b-b30f-a379eed764d93
312941sertraline (as sertraline HCl) 50 MG Oral TabletSY5b73a90e-b883-419b-b30f-a379eed764d93

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72865-207-0572865020705500 TABLET in 1 BOTTLE (72865-207-05) 500 tablet2021-05-030000-00-00NoNoCurrent
72865-207-1872865020718180 TABLET in 1 BOTTLE (72865-207-18) 180 tablet2021-05-030000-00-00NoNoCurrent
72865-207-307286502073030 TABLET in 1 BOTTLE (72865-207-30) 30 tablet2021-05-030000-00-00NoNoCurrent
72865-207-907286502079090 TABLET in 1 BOTTLE (72865-207-90) 90 tablet2021-05-030000-00-00NoNoCurrent