Sertraline Hydrochloride

Product NDC
43353-970
11-digit product format
433530970
Labeler code
43353
Product ID
43353-970_1e0a30cf-a624-4b41-aa91-c6fde1419cdf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sertraline Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA077397
Marketing category
ANDA
Marketing start
2007-10-18
Marketing end
0000-00-00
Substance
SERTRALINE HYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct43353-970DDiscontinued by firm2026-08-10
excluded packagepackage43353-97043353-970-30DDiscontinued by firm2026-08-10

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
A077397-001SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2007-02-06
A077397-002SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2007-02-06
A077397-003SERTRALINE 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
A077397-001AB
A077397-002AB
A077397-003AB

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 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A077397-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2007-02-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077397-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2007-02-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077397-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2007-02-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077397-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2007-02-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077397-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2007-02-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077397-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2007-02-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A077397-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2007-02-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077397-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2007-02-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077397-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2007-02-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077397-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2007-02-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077397-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2007-02-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077397-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2007-02-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077397-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2007-02-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077397-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2007-02-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077397-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2007-02-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077397-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2007-02-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077397-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2007-02-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077397-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2007-02-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077397-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2007-02-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077397-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2007-02-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077397-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2007-02-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077397-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2007-02-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077397-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2007-02-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077397-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2007-02-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077397-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2007-02-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077397-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2007-02-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077397-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2007-02-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077397-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2007-02-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A077397-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2007-02-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A077397-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2007-02-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077397-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2007-02-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077397-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2007-02-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077397-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2007-02-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077397-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2007-02-06301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077397-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2007-02-06301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077397-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2007-02-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077397-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2007-02-061e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077397-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2007-02-061e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077397-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2007-02-061e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077397-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2007-02-068072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A077397-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077397-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077397-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077397-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077397-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077397-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077397-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077397-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077397-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077397-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077397-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077397-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077397-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077397-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077397-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077397-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077397-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077397-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077397-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077397-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077397-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077397-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077397-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077397-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077397-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077397-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077397-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077397-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077397-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077397-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077397-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077397-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077397-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077397-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077397-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077397-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077397-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077397-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077397-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077397-001AB18072bd15b7f6…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-970-30EA - Each43353-9704d9cef24-e71c-4836-b4e9-b6cea4b5aaa712016-07-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-970SERTRALINE HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Legacy NDC20160707_37d03cf5-3011-40fe-87f7-4205ba6dd1bb.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 · 19 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDECoupler LLC56442b06-c135-a035-e063-6394a90a171b2026-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077397
application number: ANDA077397
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDELegacy Pharmaceutical Packaging, LLCbd86b293-dab9-4d37-95eb-2bffca335d162026-03-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077397
application number: ANDA077397
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEQuallent Pharmaceuticals Health LLC61835f25-bfe4-49ac-9dbf-3d6387866e782026-02-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077397
application number: ANDA077397
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDECipla USA Inc.cf71d1b9-5ebb-429f-a07f-a87cd168250f2026-02-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077397
application number: ANDA077397
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDENorthwind Health Company, LLCab30b0a4-6696-19da-e053-2995a90a29aa2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077397
application number: ANDA077397
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDECardinal Health 107, LLC7e5e76cf-2fda-4f9d-bcbf-f77b1f188ee62025-10-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077397
application number: ANDA077397
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.52c88667-c67e-4d42-b319-afb354713b1e2025-10-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077397
application number: ANDA077397
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.adfcc867-1b6e-4698-94b6-2b4190c4ba3d2025-10-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077397
application number: ANDA077397
SERTRALINESERTRALINEAphena Pharma Solutions - Tennessee, LLC1548faf9-8625-f871-e063-6394a90a931f2025-07-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077397
application number: ANDA077397
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEREMEDYREPACK INC.7d598f1a-6c76-458a-a155-7a6a0743a2d32025-05-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077397
application number: ANDA077397
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC30b94d67-0000-a045-e063-6394a90ade322025-03-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077397
application number: ANDA077397
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEAmerican Health Packaging4e09f580-d612-416c-a4a4-79a4411845b22024-11-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077397
application number: ANDA077397
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.7cadc747-5606-8efe-e053-2991aa0a1d8f2024-06-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077397
application number: ANDA077397
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEBryant Ranch Prepack22c4b114-5f70-4c64-aa7f-b4169729b8472024-04-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077397
application number: ANDA077397
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEBryant Ranch Prepack9bcef7ef-4e2f-4ab9-9c0f-f4956bfdd71b2024-04-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077397
application number: ANDA077397
SERTRALINESERTRALINEAphena Pharma Solutions - Tennessee, LLC7be6a62e-0e85-47c8-8793-b41c51c2557f2024-03-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077397
application number: ANDA077397
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEProficient Rx LP787a683a-091c-4908-a643-ecbc8fd467eb2020-02-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077397
application number: ANDA077397
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEProficient Rx LP00179766-980b-44b0-99d3-1fee2bb27e372019-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077397
application number: ANDA077397
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEProficient Rx LP551d5946-00df-4608-96a2-b29f0ef93ba02019-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077397
application number: ANDA077397

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43353-970-304335309703030 TABLET in 1 BOTTLE (43353-970-30) 30 tablet2014-10-090000-00-00NoNoCurrent