SERTRALINE HYDROCHLORIDE

Product NDC: 43602-980
11-digit product format: 436020980
Labeler code: 43602
Product ID: 43602-980_91447af3-b3d6-4ffe-8c89-1869a22373ba
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: sertraline hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Ascent Pharmaceuticals, Inc.
Application: ANDA214790
Marketing category: ANDA
Marketing start: 2021-05-03
Substance: SERTRALINE HYDROCHLORIDE
Active strength: 50 mg/1
Pharmacologic classes: Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: SERTRALINE HYDROCHLORIDE
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SERTRALINE HYDROCHLORIDE	50 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
UTI8907Y6X	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
312938	Internal RxNorm lookup
312940	Internal RxNorm lookup
312941	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
056191ca-999a-4c9b-93b9-64db44b8e628	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
43602-980-15	SERTRALINE HYDROCHLORIDE	30 in 1 BOTTLE	TABLET	30		1
43602-980-16	SERTRALINE HYDROCHLORIDE	500 in 1 BOTTLE	TABLET	500		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43602-980	SERTRALINE HYDROCHLORIDE TABLET [ASCENT PHARMACEUTICALS, INC.]	1	Current NDC, Legacy NDC, 2 package rows	20210803_056191ca-999a-4c9b-93b9-64db44b8e628.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 ndc (product): 43602-980

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	056191ca-999a-4c9b-93b9-64db44b8e628	1
312940	sertraline HCl 25 MG Oral Tablet	PSN	056191ca-999a-4c9b-93b9-64db44b8e628	1
312941	sertraline HCl 50 MG Oral Tablet	PSN	056191ca-999a-4c9b-93b9-64db44b8e628	1
312938	sertraline 100 MG Oral Tablet	SCD	056191ca-999a-4c9b-93b9-64db44b8e628	1
312940	sertraline 25 MG Oral Tablet	SCD	056191ca-999a-4c9b-93b9-64db44b8e628	1
312941	sertraline 50 MG Oral Tablet	SCD	056191ca-999a-4c9b-93b9-64db44b8e628	1
312938	sertraline (as sertraline HCl) 100 MG Oral Tablet	SY	056191ca-999a-4c9b-93b9-64db44b8e628	1
312940	sertraline (as sertraline HCl) 25 MG Oral Tablet	SY	056191ca-999a-4c9b-93b9-64db44b8e628	1
312941	sertraline (as sertraline HCl) 50 MG Oral Tablet	SY	056191ca-999a-4c9b-93b9-64db44b8e628	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
43602-980-15	43602098015	30 TABLET in 1 BOTTLE (43602-980-15)	30 tablet	2021-05-03	0000-00-00	No	No	Current
43602-980-16	43602098016	500 TABLET in 1 BOTTLE (43602-980-16)	500 tablet	2021-05-03	0000-00-00	No	No	Current