SERTRALINE HYDROCHLORIDE

Product NDC: 43602-462
11-digit product format: 436020462
Labeler code: 43602
Product ID: 43602-462_43908d66-b866-4556-bd54-2696fb58037c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: sertraline hydrochloride
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Ascent Pharmaceuticals, Inc
Application: ANDA214790
Marketing category: ANDA
Marketing start: 2021-05-03
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: 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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	43602-462		D	Discontinued by firm	2026-08-17
excluded package	package	43602-462	43602-462-05	D	Discontinued by firm	2026-08-17
excluded package	package	43602-462	43602-462-30	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 · 57 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		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43602-462-30	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43602-462-05	D	Discontinued by firm	`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	43602-462-05	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43602-462-30	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	43602-462-05	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43602-462-30	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	43602-462-05	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43602-462-30	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	43602-462-05	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43602-462-30	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	43602-462-05	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43602-462-30	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43602-462-05	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43602-462-30	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	43602-462-05	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	43602-462-30	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	43602-462-05	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	43602-462-30	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	43602-462-05	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	43602-462-30	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	43602-462-05	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	43602-462-30	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	43602-462-05	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	43602-462-30	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	43602-462-05	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	43602-462-30	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	43602-462-05	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	43602-462-30	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	43602-462-05	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	43602-462-30	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	43602-462-30	E	Excluded after deficient or non-compliant submission was not corrected	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	43602-462-05	E	Excluded after deficient or non-compliant submission was not corrected	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	43602-462-30	E	Excluded after deficient or non-compliant submission was not corrected	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	43602-462-05	E	Excluded after deficient or non-compliant submission was not corrected	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	43602-462-30	E	Excluded after deficient or non-compliant submission was not corrected	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	43602-462-05	E	Excluded after deficient or non-compliant submission was not corrected	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	43602-462-30	E	Excluded after deficient or non-compliant submission was not corrected	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	43602-462-05	E	Excluded after deficient or non-compliant submission was not corrected	`8dfbde2a14a4…`	`c9ff85d89658…`

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A214790-001	SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB		2021-05-03
A214790-002	SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB		2021-05-03
A214790-003	SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB		2021-05-03
A214790-004	SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL		RS	2026-08-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A214790-001	AB
A214790-002	AB
A214790-003	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 3 · 103 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A214790-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB		2021-05-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214790-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB		2021-05-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214790-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB		2021-05-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214790-004	SERTRALINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL		RS	2026-08-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214790-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB		2021-05-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214790-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB		2021-05-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214790-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB		2021-05-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214790-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB		2021-05-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214790-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB		2021-05-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214790-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB		2021-05-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214790-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB		2021-05-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214790-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB		2021-05-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214790-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB		2021-05-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214790-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB		2021-05-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214790-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB		2021-05-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214790-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB		2021-05-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214790-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB		2021-05-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214790-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB		2021-05-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214790-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB		2021-05-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214790-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB		2021-05-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214790-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB		2021-05-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214790-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB		2021-05-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214790-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB		2021-05-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214790-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB		2021-05-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214790-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB		2021-05-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214790-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB		2021-05-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214790-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB		2021-05-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214790-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB		2021-05-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214790-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB		2021-05-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214790-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB		2021-05-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214790-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB		2021-05-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214790-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB		2021-05-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214790-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB		2021-05-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214790-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB		2021-05-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214790-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB		2021-05-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214790-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB		2021-05-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214790-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB		2021-05-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214790-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB		2021-05-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214790-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB		2021-05-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214790-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB		2021-05-03	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 102 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	A214790-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214790-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214790-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214790-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214790-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214790-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214790-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214790-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214790-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214790-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214790-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214790-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214790-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214790-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214790-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214790-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214790-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214790-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214790-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214790-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214790-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214790-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214790-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214790-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214790-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214790-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214790-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214790-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214790-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214790-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214790-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214790-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214790-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214790-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214790-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214790-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214790-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214790-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214790-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214790-001	AB	1	`1e350fbaab3a…`

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
43602-462-05	2025-11-04	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
43602-462-30	2025-11-04	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
43602-462-05	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
43602-462-30	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 Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43602-462	SERTRALINE HYDROCHLORIDE TABLET, EXTENDED RELEASE [ASCENT PHARMACEUTICALS, INC]	2	Legacy NDC	20210508_5f6674af-8a24-4ea3-867e-7fafe6e7d578.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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	48702ef4-21cd-754e-e063-6394a90af24e	2026-01-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214790 application number: ANDA214790
SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	A-S Medication Solutions	2bb3a2d1-76c4-42e6-8553-aa95f263175b	2025-10-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214790 application number: ANDA214790
SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	A-S Medication Solutions	c0cc1b03-ba35-4a2c-be95-2d9b7f4c3499	2025-10-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214790 application number: ANDA214790
SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	A-S Medication Solutions	50b54bfa-0b90-44f1-8f73-4f7f552449c4	2025-10-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214790 application number: ANDA214790
SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	A-S Medication Solutions	45af84f5-c284-4e82-ad3c-e9b7ab2b8114	2025-10-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214790 application number: ANDA214790
SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	Camber Pharmaceuticals, Inc.	de1f85ac-df1b-4b7b-8e18-48ebdc8b9279	2024-09-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214790 application number: ANDA214790
SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	XLCare Pharmaceuticals, Inc.	5b73a90e-b883-419b-b30f-a379eed764d9	2023-06-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214790 application number: ANDA214790
SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	Ascent Pharmaceuticals, Inc.	056191ca-999a-4c9b-93b9-64db44b8e628	2021-05-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214790 application number: ANDA214790

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
43602-462-05	43602046205	500 TABLET, EXTENDED RELEASE in 1 BOTTLE (43602-462-05)	2021-05-03	0000-00-00	No	No	Current
43602-462-30	43602046230	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (43602-462-30)	2021-05-03	0000-00-00	No	No	Current