SERTRALINE HYDROCHLORIDE

Product NDC
43063-855
11-digit product format
430630855
Labeler code
43063
Product ID
43063-855_525b23be-4bed-f30f-e063-6294a90a1773
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SERTRALINE HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA202825
Marketing category
ANDA
Marketing start
2017-02-09
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
2027-12-31
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A202825-001SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2014-11-07
A202825-002SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2014-11-07
A202825-003SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2014-11-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A202825-001AB
A202825-002AB
A202825-003AB

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 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A202825-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2014-11-07caaa826d4ba7…
2026-08-18 06:07:402026-07A202825-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2014-11-07caaa826d4ba7…
2026-08-18 06:07:402026-07A202825-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2014-11-07caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202825-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2014-11-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202825-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2014-11-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202825-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2014-11-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202825-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2014-11-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202825-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2014-11-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202825-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2014-11-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A202825-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2014-11-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202825-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2014-11-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202825-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2014-11-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202825-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2014-11-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202825-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2014-11-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202825-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2014-11-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202825-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2014-11-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202825-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2014-11-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202825-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2014-11-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202825-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2014-11-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202825-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2014-11-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202825-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2014-11-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202825-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2014-11-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202825-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2014-11-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202825-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2014-11-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202825-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2014-11-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202825-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2014-11-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202825-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2014-11-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202825-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2014-11-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202825-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2014-11-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202825-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2014-11-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202825-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2014-11-07d06236e962d9…
2024-10-29 15:01 UTC2024-10A202825-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2014-11-07d06236e962d9…
2024-10-29 15:01 UTC2024-10A202825-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2014-11-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202825-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2014-11-0779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202825-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2014-11-0779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202825-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2014-11-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202825-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2014-11-07301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202825-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2014-11-07301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202825-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2014-11-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202825-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2014-11-071e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A202825-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202825-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202825-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202825-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202825-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202825-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202825-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202825-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202825-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202825-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202825-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202825-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202825-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202825-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202825-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202825-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202825-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202825-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202825-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202825-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202825-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202825-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202825-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202825-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202825-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202825-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202825-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202825-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202825-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202825-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202825-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A202825-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A202825-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202825-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202825-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202825-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202825-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202825-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202825-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202825-001AB11e350fbaab3a…

Additional Listing Data#

Finished product
Yes
Brand name base
SERTRALINE HYDROCHLORIDE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SERTRALINE HYDROCHLORIDE50 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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
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
aa13261f-46a7-4381-8084-b3ad46221e2fAvailable 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
43063-855-30SERTRALINE HYDROCHLORIDE30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3021
43063-855-60SERTRALINE HYDROCHLORIDE60 in 1 BOTTLE, PLASTICTABLET, FILM COATED6021
43063-855-90SERTRALINE HYDROCHLORIDE90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9021

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-855-30EA - Each43063-85505d84fe7-4a71-4bf9-8e42-47b3b616c27e12018-08-13
43063-855-60EA - Each43063-855e99266be-1df5-4de3-ae74-526e7c71f02412018-08-13
43063-855-90EA - Each43063-8553bee4ed9-df40-4a3c-a091-cc56e1e40c6312018-07-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-855SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]19Current NDC, Legacy NDC, 3 package rows20240704_aa13261f-46a7-4381-8084-b3ad46221e2f.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 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEBryant Ranch Prepacke919f195-0ce1-4d71-9883-efec05b9a0502026-06-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202825
application number: ANDA202825
SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDESt. Mary's Medical Park Pharmacy730448bf-2d78-44a4-e053-2991aa0ada9e2026-06-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202825
application number: ANDA202825
SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEBryant Ranch Prepack5e91adad-9757-49e4-a3f1-1db0ef3964162026-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202825
application number: ANDA202825
SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.aa13261f-46a7-4381-8084-b3ad46221e2f2026-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202825
application number: ANDA202825
ndc (product): 43063-855
SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEAccord Healthcare, Inc.205ecf52-8138-44a7-ad9a-b3aa7f4fa11a2025-12-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202825
application number: ANDA202825
SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEQPharma, Inc.dc97a895-8c2f-4891-85f3-7f45e23961402025-12-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202825
application number: ANDA202825
SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.2beb45ca-0ebb-4908-807a-7413250693e32025-09-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202825
application number: ANDA202825
SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEBryant Ranch Prepack82a44e20-d0ee-4ed7-9234-24ef4496ac1d2024-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202825
application number: ANDA202825
SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEA-S Medication Solutions14c4fa96-8919-4ea7-ad72-129f288d8cfc2023-05-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202825
application number: ANDA202825
SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC68c94fb4-3018-44af-b982-2b4b6d461e6f2022-06-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202825
application number: ANDA202825
SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEProficient Rx LP6b532e6a-b040-4a10-a242-fb6d8dfc08522019-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202825
application number: ANDA202825

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312941sertraline HCl 50 MG Oral TabletPSNaa13261f-46a7-4381-8084-b3ad46221e2f21
312941sertraline 50 MG Oral TabletSCDaa13261f-46a7-4381-8084-b3ad46221e2f21
312941sertraline (as sertraline HCl) 50 MG Oral TabletSYaa13261f-46a7-4381-8084-b3ad46221e2f21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43063-855-304306308553030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-855-30) 2018-07-090000-00-00NoNoCurrent
43063-855-604306308556060 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-855-60) 2018-07-090000-00-00NoNoCurrent
43063-855-904306308559090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-855-90) 2018-05-290000-00-00NoNoCurrent