Sertraline Hydrochloride

Product NDC: 53002-3192
11-digit product format: 530023192
Labeler code: 53002
Product ID: 53002-3192_847c7b3d-3633-4927-8e13-fec383d44591
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sertraline Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: RPK Pharmaceuticals, Inc.
Application: ANDA077206
Marketing category: ANDA
Marketing start: 2007-02-06
Marketing end: 0000-00-00
Substance: SERTRALINE HYDROCHLORIDE
Active strength: 50 mg/1
Pharmacologic classes: Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2022-12-31
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	53002-3192		I	Inactivated by FDA	2026-10-05
excluded package	package	53002-3192	53002-3192-0	I	Inactivated by FDA	2026-10-05
excluded package	package	53002-3192	53002-3192-1	I	Inactivated by FDA	2026-10-05
excluded package	package	53002-3192	53002-3192-3	I	Inactivated by FDA	2026-10-05
excluded package	package	53002-3192	53002-3192-6	I	Inactivated by FDA	2026-10-05

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 · 45 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53002-3192-0	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53002-3192-1	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53002-3192-3	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53002-3192-6	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53002-3192-0	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53002-3192-1	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53002-3192-3	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53002-3192-6	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53002-3192-0	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53002-3192-1	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53002-3192-3	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53002-3192-6	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53002-3192-0	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53002-3192-1	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53002-3192-3	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53002-3192-6	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53002-3192-0	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53002-3192-1	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53002-3192-3	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53002-3192-6	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53002-3192-0	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53002-3192-1	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53002-3192-3	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53002-3192-6	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53002-3192-3	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53002-3192-0	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53002-3192-6	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53002-3192-1	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53002-3192-3	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53002-3192-0	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53002-3192-6	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53002-3192-1	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53002-3192-3	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53002-3192-0	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53002-3192-6	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53002-3192-1	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A077206-001	SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2007-02-06
A077206-002	SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2007-02-06
A077206-003	SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2007-02-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077206-001	AB
A077206-002	AB
A077206-003	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 · 129 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
2026-09-14 22:38:34	2026-08	A077206-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2007-02-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077206-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2007-02-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077206-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2007-02-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077206-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2007-02-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077206-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2007-02-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077206-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2007-02-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077206-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2007-02-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077206-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2007-02-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077206-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2007-02-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077206-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2007-02-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077206-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2007-02-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077206-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2007-02-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077206-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2007-02-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077206-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2007-02-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077206-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2007-02-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077206-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2007-02-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077206-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2007-02-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077206-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2007-02-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077206-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2007-02-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077206-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2007-02-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077206-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2007-02-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077206-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2007-02-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077206-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2007-02-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077206-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2007-02-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077206-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2007-02-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077206-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2007-02-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077206-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2007-02-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077206-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2007-02-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077206-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2007-02-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077206-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2007-02-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077206-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2007-02-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077206-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2007-02-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077206-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2007-02-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077206-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2007-02-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077206-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2007-02-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077206-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2007-02-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077206-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2007-02-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077206-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2007-02-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077206-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2007-02-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077206-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2007-02-06	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A077206-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077206-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077206-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077206-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077206-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077206-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077206-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077206-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077206-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077206-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077206-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077206-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077206-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077206-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077206-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077206-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077206-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077206-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077206-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077206-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077206-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077206-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077206-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077206-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077206-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077206-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077206-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077206-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077206-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077206-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077206-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077206-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077206-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077206-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077206-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077206-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077206-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077206-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077206-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077206-001	AB	1	`301d65b070ca…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
4ac594ea-ad8b-47fd-9b52-bbd98301675e	Product name	1	20220317
255fa467-900b-5557-4215-6823352d1150	Product name	2	20211028

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
53002-3192-0	2025-01-30	These highlights do not include all the information needed to use SERTRALINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for SERTRALINE HYDROCHLORIDE TABLETS. SERTRALINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1991
53002-3192-1	2025-01-30	These highlights do not include all the information needed to use SERTRALINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for SERTRALINE HYDROCHLORIDE TABLETS. SERTRALINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1991
53002-3192-3	2025-01-30	These highlights do not include all the information needed to use SERTRALINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for SERTRALINE HYDROCHLORIDE TABLETS. SERTRALINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1991
53002-3192-6	2025-01-30	These highlights do not include all the information needed to use SERTRALINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for SERTRALINE HYDROCHLORIDE TABLETS. SERTRALINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1991
53002-3192-0	2023-06-07	These highlights do not include all the information needed to use SERTRALINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for SERTRALINE HYDROCHLORIDE TABLETS. SERTRALINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1991
53002-3192-1	2023-06-07	These highlights do not include all the information needed to use SERTRALINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for SERTRALINE HYDROCHLORIDE TABLETS. SERTRALINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1991
53002-3192-3	2023-06-07	These highlights do not include all the information needed to use SERTRALINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for SERTRALINE HYDROCHLORIDE TABLETS. SERTRALINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1991
53002-3192-6	2023-06-07	These highlights do not include all the information needed to use SERTRALINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for SERTRALINE HYDROCHLORIDE TABLETS. SERTRALINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1991
53002-3192-0	2023-01-30	These highlights do not include all the information needed to use SERTRALINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for SERTRALINE HYDROCHLORIDE TABLETS. SERTRALINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1991
53002-3192-1	2023-01-30	These highlights do not include all the information needed to use SERTRALINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for SERTRALINE HYDROCHLORIDE TABLETS. SERTRALINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1991
53002-3192-3	2023-01-30	These highlights do not include all the information needed to use SERTRALINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for SERTRALINE HYDROCHLORIDE TABLETS. SERTRALINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1991
53002-3192-6	2023-01-30	These highlights do not include all the information needed to use SERTRALINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for SERTRALINE HYDROCHLORIDE TABLETS. SERTRALINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1991

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
53002-3192-0	Sertraline Hydrochloride	100 in 1 BOTTLE	TABLET, FILM COATED	100	5
53002-3192-1	Sertraline Hydrochloride	10 in 1 BOTTLE	TABLET, FILM COATED	10	5
53002-3192-3	Sertraline Hydrochloride	30 in 1 BOTTLE	TABLET, FILM COATED	30	5
53002-3192-6	Sertraline Hydrochloride	60 in 1 BOTTLE	TABLET, FILM COATED	60	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53002-3192	SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [RPK PHARMACEUTICALS, INC.]	5	Legacy NDC, 4 package rows	20230609_6c90d88f-3e9c-4306-9e82-6dbc831787a1.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 2 of 3 · 52 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	3ca30f3f-545e-46c5-b56a-73ec48e9647f	2025-10-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077206 application number: ANDA077206
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	91b4c802-9c6b-49bb-b5a7-661e1917ef34	2025-10-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077206 application number: ANDA077206
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Bryant Ranch Prepack	50d0aef5-ecc7-49b0-964a-53f87058d22a	2025-07-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077206 application number: ANDA077206
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	680890b1-bc45-4f50-9aaf-e730ab515b85	2025-03-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077206 application number: ANDA077206
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Asclemed USA, Inc.	e25a13c3-a173-4cc3-99d3-0be43abbc498	2025-02-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077206 application number: ANDA077206
SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	DIRECT RX	ab962a5a-fff6-2cf9-e053-2995a90ace0f	2025-01-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077206 application number: ANDA077206
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	c4bad433-623b-402c-b454-d39f19a23627	2025-01-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077206 application number: ANDA077206
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	0e5a7b02-3972-47f0-9f49-e958d792beac	2025-01-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077206 application number: ANDA077206
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	ae3be25b-2bde-4142-ad56-920a96ac8f39	2025-01-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077206 application number: ANDA077206
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Advanced Rx Pharmacy of Tennessee, LLC	ec1b68d3-ff55-d0a2-e053-2a95a90a2e0b	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077206 application number: ANDA077206
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Advanced Rx Pharmacy of Tennessee, LLC	f8c45a99-18ed-0e1f-e053-6394a90a2d52	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077206 application number: ANDA077206
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Quality Care Products LLC	25aef6c1-9964-44a1-a905-c37e5c28a3c0	2024-12-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077206 application number: ANDA077206
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Bryant Ranch Prepack	9f1d5689-3bf1-431c-9ea2-9e37217ecf40	2024-10-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077206 application number: ANDA077206
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Bryant Ranch Prepack	4191b929-5bdb-4388-9e4d-fffce55bc363	2024-10-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077206 application number: ANDA077206
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Bryant Ranch Prepack	c6897cf2-1349-400d-ab22-1e88f097b693	2024-08-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077206 application number: ANDA077206
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Bryant Ranch Prepack	2f81b0c4-9ad9-4dda-8950-70321a8769e4	2024-08-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077206 application number: ANDA077206
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	8e105aeb-6e17-a025-e053-2995a90aba77	2024-06-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077206 application number: ANDA077206
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	8e98ee4c-24df-88ce-e053-2a95a90a6713	2024-06-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077206 application number: ANDA077206
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	6dd71a5b-1923-54fb-e053-2991aa0a619e	2024-06-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077206 application number: ANDA077206
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	71224928-685a-355c-e053-2995a90a0a5b	2024-06-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077206 application number: ANDA077206

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
312941	sertraline HCl 50 MG Oral Tablet	PSN	6c90d88f-3e9c-4306-9e82-6dbc831787a1	5
312941	sertraline 50 MG Oral Tablet	SCD	6c90d88f-3e9c-4306-9e82-6dbc831787a1	5
312941	sertraline (as sertraline HCl) 50 MG Oral Tablet	SY	6c90d88f-3e9c-4306-9e82-6dbc831787a1	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
53002-3192-0	53002319200	100 TABLET, FILM COATED in 1 BOTTLE (53002-3192-0)	2019-01-01	0000-00-00	No	No	Current
53002-3192-1	53002319201	10 TABLET, FILM COATED in 1 BOTTLE (53002-3192-1)	2019-01-01	0000-00-00	No	No	Current
53002-3192-3	53002319203	30 TABLET, FILM COATED in 1 BOTTLE (53002-3192-3)	2019-01-01	0000-00-00	No	No	Current
53002-3192-6	53002319206	60 TABLET, FILM COATED in 1 BOTTLE (53002-3192-6)	2019-01-01	0000-00-00	No	No	Current