SERTRALINE HYDROCHLORIDE

Product NDC: 71093-131
Requested package NDC: 71093-131-05
11-digit product format: 710930131
Labeler code: 71093
Product ID: 71093-131_701d9091-1809-4afe-94af-f36fd04c174a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: SERTRALINE HYDROCHLORIDE
Dosage form: TABLET
Route: ORAL
Labeler: ACI Healthcare USA, Inc.
Application: ANDA076881
Marketing category: ANDA
Marketing start: 2007-02-06
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#

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	71093-131	71093-131-05	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
A076881-001	SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2007-02-06
A076881-002	SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2007-02-06
A076881-003	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
A076881-001	AB
A076881-002	AB
A076881-003	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 · 123 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
2026-02-19 14:30 UTC	2026-02	A076881-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2007-02-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076881-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2007-02-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076881-003	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	A076881-001	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	A076881-002	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	A076881-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2007-02-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076881-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2007-02-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076881-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2007-02-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076881-003	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	A076881-001	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	A076881-002	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	A076881-003	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	A076881-001	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	A076881-002	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	A076881-003	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	A076881-001	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	A076881-002	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	A076881-003	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	A076881-001	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	A076881-002	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	A076881-003	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	A076881-001	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	A076881-002	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	A076881-003	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	A076881-001	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	A076881-002	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	A076881-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2007-02-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076881-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2007-02-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076881-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2007-02-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076881-003	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	A076881-001	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	A076881-002	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	A076881-003	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	A076881-001	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	A076881-002	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	A076881-003	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	A076881-001	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	A076881-002	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	A076881-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2007-02-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076881-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2007-02-06	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 105 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A076881-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076881-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076881-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076881-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076881-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076881-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076881-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076881-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076881-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076881-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076881-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076881-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076881-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076881-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076881-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076881-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076881-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076881-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076881-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076881-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076881-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076881-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076881-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076881-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076881-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076881-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076881-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076881-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076881-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076881-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076881-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076881-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076881-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076881-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076881-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076881-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076881-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076881-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076881-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076881-001	AB	1	`8072bd15b7f6…`

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	SPL version
71093-131-01	SERTRALINE HYDROCHLORIDE	30 in 1 BOTTLE, PLASTIC	TABLET	30	6
71093-131-03	SERTRALINE HYDROCHLORIDE	90 in 1 BOTTLE, PLASTIC	TABLET	90	6
71093-131-05	SERTRALINE HYDROCHLORIDE	500 in 1 BOTTLE, PLASTIC	TABLET	500	6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71093-131-01	EA - Each	71093-131	1beb7ea8-d95e-4362-a3b3-b08f1e8ff798	1	2021-08-05
71093-131-03	EA - Each	71093-131	34d2cfce-f076-49af-83f1-c52f330712d5	1	2021-08-05
71093-131-05	EA - Each	71093-131	bb4e3a2f-53db-4749-9d5c-79ca95083424	1	2021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71093-131	SERTRALINE HYDROCHLORIDE TABLET [ACI HEALTHCARE USA, INC.]	6	Legacy NDC, 3 package rows	20230410_1f99e897-1b70-40b0-8c19-71d0bba19422.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	1f99e897-1b70-40b0-8c19-71d0bba19422	6
312940	sertraline HCl 25 MG Oral Tablet	PSN	1f99e897-1b70-40b0-8c19-71d0bba19422	6
312941	sertraline HCl 50 MG Oral Tablet	PSN	1f99e897-1b70-40b0-8c19-71d0bba19422	6
312938	sertraline 100 MG Oral Tablet	SCD	1f99e897-1b70-40b0-8c19-71d0bba19422	6
312940	sertraline 25 MG Oral Tablet	SCD	1f99e897-1b70-40b0-8c19-71d0bba19422	6
312941	sertraline 50 MG Oral Tablet	SCD	1f99e897-1b70-40b0-8c19-71d0bba19422	6
312938	sertraline (as sertraline HCl) 100 MG Oral Tablet	SY	1f99e897-1b70-40b0-8c19-71d0bba19422	6
312940	sertraline (as sertraline HCl) 25 MG Oral Tablet	SY	1f99e897-1b70-40b0-8c19-71d0bba19422	6
312941	sertraline (as sertraline HCl) 50 MG Oral Tablet	SY	1f99e897-1b70-40b0-8c19-71d0bba19422	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71093-131-05	71093013105	500 TABLET in 1 BOTTLE, PLASTIC (71093-131-05)	500 tablet	2018-08-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
SERTRALINE HYDROCHLORIDE	ACI Healthcare USA, Inc. \| ACI HealthCare Limited \| Elysium Pharmaceuticals Limited \| InvaTech Pharma Solutions LLC	2023-04-09	HUMAN PRESCRIPTION DRUG LABEL	6