Sertraline Hydrochloride

Product NDC: 42337-203
11-digit product format: 423370203
Labeler code: 42337
Product ID: 42337-203_e8c17511-93ca-2cf2-e053-2a95a90a1dde
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: sertraline hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Viwit Pharmaceutical Co., Ltd.
Application: ANDA076882
Marketing category: ANDA
Marketing start: 2021-02-28
Marketing end: 0000-00-00
Substance: SERTRALINE HYDROCHLORIDE
Active strength: 100 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#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 6 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	42337-203		I	Inactivated by FDA	2026-08-03
excluded package	package	42337-203	42337-203-01	I	Inactivated by FDA	2026-08-03
excluded package	package	42337-203	42337-203-02	I	Inactivated by FDA	2026-08-03
excluded package	package	42337-203	42337-203-03	I	Inactivated by FDA	2026-08-03
excluded package	package	42337-203	42337-203-04	I	Inactivated by FDA	2026-08-03
excluded package	package	42337-203	42337-203-05	I	Inactivated by FDA	2026-08-03

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A076882-001	SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2007-02-06
A076882-002	SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2007-02-06
A076882-003	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
A076882-001	AB
A076882-002	AB
A076882-003	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 · 99 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
2024-11-08 22:44 UTC · 2 captures of this ZIP	2024-11	A076882-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2007-02-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 2 captures of this ZIP	2024-11	A076882-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2007-02-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 2 captures of this ZIP	2024-11	A076882-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2007-02-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076882-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2007-02-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076882-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2007-02-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076882-003	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	A076882-001	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	A076882-002	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	A076882-003	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	A076882-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2007-02-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076882-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2007-02-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076882-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2007-02-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076882-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2007-02-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076882-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2007-02-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076882-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2007-02-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076882-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2007-02-06	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076882-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2007-02-06	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076882-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2007-02-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076882-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2007-02-06	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076882-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2007-02-06	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076882-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2007-02-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076882-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2007-02-06	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076882-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2007-02-06	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076882-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2007-02-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076882-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2007-02-06	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076882-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2007-02-06	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076882-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2007-02-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076882-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2007-02-06	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076882-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2007-02-06	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076882-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2007-02-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076882-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2007-02-06	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076882-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2007-02-06	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076882-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2007-02-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076882-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2007-02-06	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A076882-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2007-02-06	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A076882-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2007-02-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076882-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2007-02-06	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076882-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2007-02-06	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076882-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2007-02-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076882-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2007-02-06	`5aa47cf7b7d7…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 99 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-11-08 22:44 UTC · 2 captures of this ZIP	2024-11	A076882-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 2 captures of this ZIP	2024-11	A076882-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 2 captures of this ZIP	2024-11	A076882-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076882-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076882-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076882-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076882-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076882-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076882-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076882-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076882-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076882-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076882-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076882-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076882-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076882-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076882-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076882-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076882-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076882-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076882-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076882-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076882-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076882-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076882-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076882-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076882-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076882-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076882-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076882-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076882-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076882-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076882-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076882-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A076882-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A076882-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076882-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076882-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076882-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076882-001	AB	1	`5aa47cf7b7d7…`

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, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
42337-203-01	2024-01-30	C162847	48780-1	1030e365-36a7-111a-e063-dadaa90a10e2	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
42337-203-02	2024-01-30	C162847	48780-1	1030e365-36a7-111a-e063-dadaa90a10e2	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
42337-203-03	2024-01-30	C162847	48780-1	1030e365-36a7-111a-e063-dadaa90a10e2	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
42337-203-04	2024-01-30	C162847	48780-1	1030e365-36a7-111a-e063-dadaa90a10e2	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
42337-203-05	2024-01-30	C162847	48780-1	1030e365-36a7-111a-e063-dadaa90a10e2	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
42337-203-01	Sertraline Hydrochloride	30 in 1 BOTTLE	TABLET, FILM COATED	30	1
42337-203-02	Sertraline Hydrochloride	60 in 1 BOTTLE	TABLET, FILM COATED	60	1
42337-203-03	Sertraline Hydrochloride	90 in 1 BOTTLE	TABLET, FILM COATED	90	1
42337-203-04	Sertraline Hydrochloride	180 in 1 BOTTLE	TABLET, FILM COATED	180	1
42337-203-05	Sertraline Hydrochloride	500 in 1 BOTTLE	TABLET, FILM COATED	500	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42337-203	SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [VIWIT PHARMACEUTICAL CO., LTD.]	1	Legacy NDC, 5 package rows	20220922_e8c184d1-d4a0-7777-e053-2995a90a51cc.zip

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
312938	sertraline HCl 100 MG Oral Tablet	PSN	e8c184d1-d4a0-7777-e053-2995a90a51cc	1
312940	sertraline HCl 25 MG Oral Tablet	PSN	e8c184d1-d4a0-7777-e053-2995a90a51cc	1
312941	sertraline HCl 50 MG Oral Tablet	PSN	e8c184d1-d4a0-7777-e053-2995a90a51cc	1
312938	sertraline 100 MG Oral Tablet	SCD	e8c184d1-d4a0-7777-e053-2995a90a51cc	1
312940	sertraline 25 MG Oral Tablet	SCD	e8c184d1-d4a0-7777-e053-2995a90a51cc	1
312941	sertraline 50 MG Oral Tablet	SCD	e8c184d1-d4a0-7777-e053-2995a90a51cc	1
312938	sertraline (as sertraline HCl) 100 MG Oral Tablet	SY	e8c184d1-d4a0-7777-e053-2995a90a51cc	1
312940	sertraline (as sertraline HCl) 25 MG Oral Tablet	SY	e8c184d1-d4a0-7777-e053-2995a90a51cc	1
312941	sertraline (as sertraline HCl) 50 MG Oral Tablet	SY	e8c184d1-d4a0-7777-e053-2995a90a51cc	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
42337-203-01	42337020301	30 TABLET, FILM COATED in 1 BOTTLE (42337-203-01)	2021-02-28	0000-00-00	No	No	Current
42337-203-02	42337020302	60 TABLET, FILM COATED in 1 BOTTLE (42337-203-02)	2021-02-28	0000-00-00	No	No	Current
42337-203-03	42337020303	90 TABLET, FILM COATED in 1 BOTTLE (42337-203-03)	2021-02-28	0000-00-00	No	No	Current
42337-203-04	42337020304	180 TABLET, FILM COATED in 1 BOTTLE (42337-203-04)	2021-02-28	0000-00-00	No	No	Current
42337-203-05	42337020305	500 TABLET, FILM COATED in 1 BOTTLE (42337-203-05)	2021-02-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sertraline Hydrochloride	Viwit Pharmaceutical Co., Ltd.	2022-09-22	HUMAN PRESCRIPTION DRUG LABEL	1