SERTRALINE HYDROCHLORIDE

Product NDC: 68788-7928
11-digit product format: 687887928
Labeler code: 68788
Product ID: 68788-7928_951770de-b51e-4bdf-9256-b07285474217
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: SERTRALINE HYDROCHLORIDE
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Preferred Pharmaceuticals Inc.
Application: ANDA202825
Marketing category: ANDA
Marketing start: 2021-06-14
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#

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 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	68788-7928		D	Discontinued by firm	2026-08-17
excluded package	package	68788-7928	68788-7928-1	D	Discontinued by firm	2026-08-17
excluded package	package	68788-7928	68788-7928-3	D	Discontinued by firm	2026-08-17
excluded package	package	68788-7928	68788-7928-6	D	Discontinued by firm	2026-08-17
excluded package	package	68788-7928	68788-7928-9	D	Discontinued by firm	2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 5 matching rows.

View current auxiliary records. · View the auxiliary file history.

Dataset, Scope, Package NDC table
Dataset	Scope	Package NDC
excluded product	product
excluded package	package	68788-7928-1
excluded package	package	68788-7928-6
excluded package	package	68788-7928-9
excluded package	package	68788-7928-3

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A202825-001	SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2014-11-07
A202825-002	SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2014-11-07
A202825-003	SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2014-11-07

Therapeutic equivalence codes#

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

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

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A202825-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2014-11-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202825-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2014-11-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202825-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2014-11-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202825-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2014-11-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202825-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2014-11-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202825-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2014-11-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202825-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2014-11-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202825-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2014-11-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202825-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2014-11-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202825-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2014-11-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202825-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2014-11-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202825-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2014-11-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202825-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2014-11-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202825-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2014-11-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202825-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2014-11-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202825-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2014-11-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202825-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2014-11-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202825-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2014-11-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202825-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2014-11-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202825-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2014-11-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202825-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2014-11-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202825-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2014-11-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202825-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2014-11-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202825-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2014-11-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202825-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2014-11-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202825-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2014-11-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202825-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2014-11-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202825-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2014-11-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202825-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2014-11-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202825-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2014-11-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202825-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2014-11-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202825-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2014-11-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202825-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2014-11-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202825-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2014-11-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202825-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2014-11-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202825-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2014-11-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202825-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2014-11-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202825-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2014-11-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202825-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2014-11-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202825-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2014-11-07	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A202825-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202825-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202825-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202825-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202825-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202825-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202825-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202825-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202825-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202825-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202825-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202825-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202825-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202825-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202825-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202825-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202825-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202825-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202825-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202825-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202825-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202825-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202825-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202825-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202825-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202825-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202825-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202825-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202825-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202825-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202825-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202825-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202825-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202825-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202825-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202825-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202825-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202825-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202825-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202825-001	AB	1	`1e350fbaab3a…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68788-7928-1	EA - Each	68788-7928	c98b1da3-2a1f-45c7-b781-cd45a6fc7f9f	1	2021-07-15
68788-7928-3	EA - Each	68788-7928	0a4710c4-aa4d-461d-8422-bd40c5ef99b3	1	2021-07-15
68788-7928-6	EA - Each	68788-7928	8a26514b-97f4-4688-9943-c01595a005b1	1	2021-07-15
68788-7928-9	EA - Each	68788-7928	346aca7d-7f22-4569-9752-0a5d5bc0f8d9	1	2021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-7928	SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]	4	Legacy NDC	20240809_721ad591-efe0-4617-ad58-a1070a7eb65a.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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	Bryant Ranch Prepack	e919f195-0ce1-4d71-9883-efec05b9a050	2026-06-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202825 application number: ANDA202825
SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	St. Mary's Medical Park Pharmacy	730448bf-2d78-44a4-e053-2991aa0ada9e	2026-06-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202825 application number: ANDA202825
SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	Bryant Ranch Prepack	5e91adad-9757-49e4-a3f1-1db0ef396416	2026-05-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202825 application number: ANDA202825
SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	aa13261f-46a7-4381-8084-b3ad46221e2f	2026-05-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202825 application number: ANDA202825
SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	Accord Healthcare, Inc.	205ecf52-8138-44a7-ad9a-b3aa7f4fa11a	2025-12-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202825 application number: ANDA202825
SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	QPharma, Inc.	dc97a895-8c2f-4891-85f3-7f45e2396140	2025-12-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202825 application number: ANDA202825
SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	2beb45ca-0ebb-4908-807a-7413250693e3	2025-09-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202825 application number: ANDA202825
SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	Bryant Ranch Prepack	82a44e20-d0ee-4ed7-9234-24ef4496ac1d	2024-04-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202825 application number: ANDA202825
SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	A-S Medication Solutions	14c4fa96-8919-4ea7-ad72-129f288d8cfc	2023-05-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202825 application number: ANDA202825
SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	68c94fb4-3018-44af-b982-2b4b6d461e6f	2022-06-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202825 application number: ANDA202825
SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	Proficient Rx LP	6b532e6a-b040-4a10-a242-fb6d8dfc0852	2019-11-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202825 application number: ANDA202825

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
UTI8907Y6X	SERTRALINE HYDROCHLORIDE	79559-97-0	SERTRALINE HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68788-7928-1	68788792801	100 TABLET, FILM COATED in 1 BOTTLE (68788-7928-1)	2021-06-14	0000-00-00	No	No	Current
68788-7928-3	68788792803	30 TABLET, FILM COATED in 1 BOTTLE (68788-7928-3)	2021-06-14	0000-00-00	No	No	Current
68788-7928-6	68788792806	60 TABLET, FILM COATED in 1 BOTTLE (68788-7928-6)	2021-06-14	0000-00-00	No	No	Current
68788-7928-9	68788792809	90 TABLET, FILM COATED in 1 BOTTLE (68788-7928-9)	2021-06-14	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
SERTRALINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	2024-08-07	HUMAN PRESCRIPTION DRUG LABEL	4