Sertraline Hydrochloride

Product NDC: 87441-077
Requested package NDC: 87441-077-01
11-digit product format: 874410077
Labeler code: 87441
Product ID: 87441-077_561e68dc-e9e7-795d-e063-6294a90a13b6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sertraline Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Unit Dose Solutions, Inc.
Application: ANDA077206
Marketing category: ANDA
Marketing start: 2026-07-08
Substance: SERTRALINE HYDROCHLORIDE
Active strength: 50 mg/1
Pharmacologic classes: Cytochrome P450 2D6 Inhibitors [MoA]; Serotonin Reuptake Inhibitor [EPC]; Serotonin Uptake Inhibitors [MoA]
Listing certified through: 2027-12-31
Current FDA listing: Yes

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
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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A077206-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2007-02-06	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A077206-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2007-02-06	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A077206-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2007-02-06	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A077206-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A077206-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A077206-003	AB	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 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	REMEDYREPACK INC.	91e24d17-ff0a-449c-9472-b9df74c98456	2026-07-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077206 application number: ANDA077206
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	REMEDYREPACK INC.	a2f333af-d37b-4705-ab7a-d363e3186e6e	2026-07-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077206 application number: ANDA077206
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Unit Dose Solutions, Inc.	561a8a20-be26-c4f8-e063-6394a90af072	2026-07-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077206 application number: ANDA077206
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Unit Dose Solutions, Inc.	561e7498-a606-366d-e063-6394a90a1c6a	2026-07-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077206 application number: ANDA077206 ndc (package): 87441-077-01 ndc (product): 87441-077 ndc11 (package): 87441007701
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	REMEDYREPACK INC.	575da603-b038-421f-9894-6796d9ac33cc	2026-06-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077206 application number: ANDA077206
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	St. Mary's Medical Park Pharmacy	8d444aec-cf33-b769-e053-2995a90a54be	2026-06-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077206 application number: ANDA077206
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Coupler LLC	518caa95-2cd7-a293-e063-6394a90adbd0	2026-05-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077206 application number: ANDA077206
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	St. Mary's Medical Park Pharmacy	7f81de84-0ad7-f050-e053-2a91aa0aa762	2026-05-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077206 application number: ANDA077206
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Coupler LLC	5103d12c-9453-a855-e063-6294a90a6f0c	2026-05-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077206 application number: ANDA077206
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	A-S Medication Solutions	7f62789b-61df-4b7b-9e01-c7a4dfb7e73c	2026-01-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077206 application number: ANDA077206
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	A-S Medication Solutions	90524e6e-c34f-43eb-8c30-d99faf7ae08f	2026-01-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077206 application number: ANDA077206
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Northwind Health Company, LLC	ab0b0ef7-155b-cec9-e053-2a95a90a9fce	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077206 application number: ANDA077206
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Northwind Health Company, LLC	ab1bb71f-936d-cb40-e053-2a95a90a08bb	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077206 application number: ANDA077206
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	QPharma Inc	664d1744-7b1d-43e2-98ba-1b0e69d75840	2025-12-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077206 application number: ANDA077206
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Aurobindo Pharma Limited	b497dfeb-a48c-4f2a-b309-b56f3a26a19b	2025-11-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077206 application number: ANDA077206
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Bryant Ranch Prepack	b400fed8-f425-47ff-ab42-915cb6e7f152	2025-11-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077206 application number: ANDA077206
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	8f5a71b2-2821-46a0-ac65-28d9b2db73ec	2025-10-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077206 application number: ANDA077206
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	Preferred Pharmaceuticals Inc.	677c90cd-6527-40cb-a564-571796513fcb	2025-09-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077206 application number: ANDA077206

Additional Listing Data#

Finished product: Yes
Brand name base: Sertraline Hydrochloride
Listing expiration: 2027-12-31

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
561e7498-a606-366d-e063-6394a90a1c6a	Available on FDA.report

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	Sample	Status
87441-077-01	87441007701	30 TABLET, FILM COATED in 1 BLISTER PACK (87441-077-01)	2026-07-08	0	Current