SERTRALINE HYDROCHLORIDE

Product NDC: 16729-217
11-digit product format: 167290217
Labeler code: 16729
Product ID: 16729-217_46293a9f-fad8-a06b-e063-6294a90acb9a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: SERTRALINE HYDROCHLORIDE
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Accord Healthcare, Inc.
Application: ANDA202825
Marketing category: ANDA
Marketing start: 2017-02-09
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: 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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A202825-001	SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2014-11-07
A202825-002	SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2014-11-07
A202825-003	SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2014-11-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202825-001	AB
A202825-002	AB
A202825-003	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 · 126 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
2026-08-18 06:07:40	2026-07	A202825-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2014-11-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202825-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2014-11-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202825-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2014-11-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202825-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2014-11-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202825-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2014-11-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202825-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2014-11-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202825-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2014-11-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202825-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2014-11-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202825-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2014-11-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202825-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2014-11-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202825-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2014-11-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202825-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2014-11-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202825-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2014-11-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202825-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2014-11-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202825-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2014-11-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202825-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2014-11-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202825-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2014-11-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202825-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2014-11-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202825-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2014-11-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202825-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2014-11-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202825-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2014-11-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202825-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2014-11-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202825-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2014-11-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202825-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2014-11-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202825-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2014-11-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202825-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2014-11-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202825-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2014-11-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202825-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2014-11-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202825-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2014-11-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202825-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2014-11-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202825-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2014-11-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202825-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2014-11-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202825-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2014-11-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202825-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2014-11-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202825-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2014-11-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202825-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2014-11-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202825-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2014-11-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202825-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2014-11-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202825-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2014-11-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202825-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2014-11-07	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 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	A202825-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202825-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202825-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202825-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202825-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202825-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202825-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202825-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202825-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202825-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202825-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202825-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202825-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202825-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202825-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202825-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202825-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202825-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202825-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202825-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202825-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202825-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202825-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202825-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202825-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202825-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202825-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202825-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202825-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202825-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202825-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202825-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202825-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202825-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202825-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202825-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202825-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202825-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202825-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202825-001	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	100 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
205ecf52-8138-44a7-ad9a-b3aa7f4fa11a	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	SPL version
16729-217-01	SERTRALINE HYDROCHLORIDE	100 in 1 BOTTLE	TABLET, FILM COATED	100	19
16729-217-10	SERTRALINE HYDROCHLORIDE	30 in 1 BOTTLE	TABLET, FILM COATED	30	19
16729-217-15	SERTRALINE HYDROCHLORIDE	90 in 1 BOTTLE	TABLET, FILM COATED	90	19
16729-217-16	SERTRALINE HYDROCHLORIDE	500 in 1 BOTTLE	TABLET, FILM COATED	500	19
16729-217-43	SERTRALINE HYDROCHLORIDE	100 in 1 BOX, UNIT-DOSE	TABLET, FILM COATED	100	19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16729-217-15	EA - Each	16729-217	eb3a47d7-6880-4830-8c75-df42367fdf09	1	2017-03-06
16729-217-16	EA - Each	16729-217	cf3d11b6-fdea-49ef-94bc-bcd3a4bd91fd	1	2017-03-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SERTRALINE HYDROCHLORIDE	ACTIVE INGREDIENT	UTI8907Y6X	SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]	2
SERTRALINE	ACTIVE MOIETY	QUC7NX6WMB	SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]	2
ANHYDROUS DIBASIC CALCIUM PHOSPHATE	INACTIVE INGREDIENT	L11K75P92J	SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]	2
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]	2
HYDROXYPROPYL CELLULOSE (TYPE L)	INACTIVE INGREDIENT	UKE75GEA7F	SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]	2
HYPROMELLOSE 2910 (5 MPA.S)	INACTIVE INGREDIENT	R75537T0T4	SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]	2
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]	2
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16729-217	SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]	17	Current NDC, Legacy NDC, 5 package rows	20240106_205ecf52-8138-44a7-ad9a-b3aa7f4fa11a.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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	Bryant Ranch Prepack	e919f195-0ce1-4d71-9883-efec05b9a050	2026-06-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202825 application number: ANDA202825
SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	St. Mary's Medical Park Pharmacy	730448bf-2d78-44a4-e053-2991aa0ada9e	2026-06-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202825 application number: ANDA202825
SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	Bryant Ranch Prepack	5e91adad-9757-49e4-a3f1-1db0ef396416	2026-05-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202825 application number: ANDA202825
SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	aa13261f-46a7-4381-8084-b3ad46221e2f	2026-05-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202825 application number: ANDA202825
SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	Accord Healthcare, Inc.	205ecf52-8138-44a7-ad9a-b3aa7f4fa11a	2025-12-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202825 application number: ANDA202825 ndc (product): 16729-217
SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	QPharma, Inc.	dc97a895-8c2f-4891-85f3-7f45e2396140	2025-12-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202825 application number: ANDA202825
SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	2beb45ca-0ebb-4908-807a-7413250693e3	2025-09-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202825 application number: ANDA202825
SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	Bryant Ranch Prepack	82a44e20-d0ee-4ed7-9234-24ef4496ac1d	2024-04-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202825 application number: ANDA202825
SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	A-S Medication Solutions	14c4fa96-8919-4ea7-ad72-129f288d8cfc	2023-05-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202825 application number: ANDA202825
SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	68c94fb4-3018-44af-b982-2b4b6d461e6f	2022-06-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202825 application number: ANDA202825
SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	Proficient Rx LP	6b532e6a-b040-4a10-a242-fb6d8dfc0852	2019-11-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202825 application number: ANDA202825

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	5e91adad-9757-49e4-a3f1-1db0ef396416	103
312938	sertraline 100 MG Oral Tablet	SCD	5e91adad-9757-49e4-a3f1-1db0ef396416	103
312938	sertraline (as sertraline HCl) 100 MG Oral Tablet	SY	5e91adad-9757-49e4-a3f1-1db0ef396416	103
312938	sertraline HCl 100 MG Oral Tablet	PSN	205ecf52-8138-44a7-ad9a-b3aa7f4fa11a	19
312940	sertraline HCl 25 MG Oral Tablet	PSN	205ecf52-8138-44a7-ad9a-b3aa7f4fa11a	19
312941	sertraline HCl 50 MG Oral Tablet	PSN	205ecf52-8138-44a7-ad9a-b3aa7f4fa11a	19
312938	sertraline 100 MG Oral Tablet	SCD	205ecf52-8138-44a7-ad9a-b3aa7f4fa11a	19
312940	sertraline 25 MG Oral Tablet	SCD	205ecf52-8138-44a7-ad9a-b3aa7f4fa11a	19
312941	sertraline 50 MG Oral Tablet	SCD	205ecf52-8138-44a7-ad9a-b3aa7f4fa11a	19
312938	sertraline (as sertraline HCl) 100 MG Oral Tablet	SY	205ecf52-8138-44a7-ad9a-b3aa7f4fa11a	19
312940	sertraline (as sertraline HCl) 25 MG Oral Tablet	SY	205ecf52-8138-44a7-ad9a-b3aa7f4fa11a	19
312941	sertraline (as sertraline HCl) 50 MG Oral Tablet	SY	205ecf52-8138-44a7-ad9a-b3aa7f4fa11a	19
312938	sertraline HCl 100 MG Oral Tablet	PSN	14c4fa96-8919-4ea7-ad72-129f288d8cfc	12
312938	sertraline 100 MG Oral Tablet	SCD	14c4fa96-8919-4ea7-ad72-129f288d8cfc	12
312938	sertraline (as sertraline HCl) 100 MG Oral Tablet	SY	14c4fa96-8919-4ea7-ad72-129f288d8cfc	12
312938	sertraline HCl 100 MG Oral Tablet	PSN	d1324ef1-073f-41bb-a4fd-403f3619958b	5
312940	sertraline HCl 25 MG Oral Tablet	PSN	d1324ef1-073f-41bb-a4fd-403f3619958b	5
312941	sertraline HCl 50 MG Oral Tablet	PSN	d1324ef1-073f-41bb-a4fd-403f3619958b	5
312938	sertraline 100 MG Oral Tablet	SCD	d1324ef1-073f-41bb-a4fd-403f3619958b	5
312940	sertraline 25 MG Oral Tablet	SCD	d1324ef1-073f-41bb-a4fd-403f3619958b	5
312941	sertraline 50 MG Oral Tablet	SCD	d1324ef1-073f-41bb-a4fd-403f3619958b	5
312938	sertraline (as sertraline HCl) 100 MG Oral Tablet	SY	d1324ef1-073f-41bb-a4fd-403f3619958b	5
312940	sertraline (as sertraline HCl) 25 MG Oral Tablet	SY	d1324ef1-073f-41bb-a4fd-403f3619958b	5
312941	sertraline (as sertraline HCl) 50 MG Oral Tablet	SY	d1324ef1-073f-41bb-a4fd-403f3619958b	5
312938	sertraline HCl 100 MG Oral Tablet	PSN	2beb45ca-0ebb-4908-807a-7413250693e3	4
312938	sertraline HCl 100 MG Oral Tablet	PSN	730448bf-2d78-44a4-e053-2991aa0ada9e	4
312938	sertraline 100 MG Oral Tablet	SCD	2beb45ca-0ebb-4908-807a-7413250693e3	4
312938	sertraline 100 MG Oral Tablet	SCD	730448bf-2d78-44a4-e053-2991aa0ada9e	4
312938	sertraline (as sertraline HCl) 100 MG Oral Tablet	SY	730448bf-2d78-44a4-e053-2991aa0ada9e	4
312938	sertraline (as sertraline HCl) 100 MG Oral Tablet	SY	2beb45ca-0ebb-4908-807a-7413250693e3	4
312938	sertraline HCl 100 MG Oral Tablet	PSN	6b532e6a-b040-4a10-a242-fb6d8dfc0852	3
312941	sertraline HCl 50 MG Oral Tablet	PSN	6b532e6a-b040-4a10-a242-fb6d8dfc0852	3
312938	sertraline 100 MG Oral Tablet	SCD	6b532e6a-b040-4a10-a242-fb6d8dfc0852	3
312941	sertraline 50 MG Oral Tablet	SCD	6b532e6a-b040-4a10-a242-fb6d8dfc0852	3
312938	sertraline (as sertraline HCl) 100 MG Oral Tablet	SY	6b532e6a-b040-4a10-a242-fb6d8dfc0852	3
312941	sertraline (as sertraline HCl) 50 MG Oral Tablet	SY	6b532e6a-b040-4a10-a242-fb6d8dfc0852	3
312938	sertraline HCl 100 MG Oral Tablet	PSN	68c94fb4-3018-44af-b982-2b4b6d461e6f	2
312938	sertraline 100 MG Oral Tablet	SCD	68c94fb4-3018-44af-b982-2b4b6d461e6f	2
312938	sertraline (as sertraline HCl) 100 MG Oral Tablet	SY	68c94fb4-3018-44af-b982-2b4b6d461e6f	2
312938	sertraline HCl 100 MG Oral Tablet	PSN	5c5b5d44-1efd-4853-80a6-3dcb21d5010f	1
312938	sertraline 100 MG Oral Tablet	SCD	5c5b5d44-1efd-4853-80a6-3dcb21d5010f	1
312938	sertraline (as sertraline HCl) 100 MG Oral Tablet	SY	5c5b5d44-1efd-4853-80a6-3dcb21d5010f	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
16729-217-01	16729021701	100 in 1 BOTTLE					Historical
16729-217-10	16729021710	30 in 1 BOTTLE					Historical
16729-217-15	16729021715	90 TABLET, FILM COATED in 1 BOTTLE (16729-217-15)	2017-03-10	0000-00-00	No	No	Current
16729-217-16	16729021716	500 TABLET, FILM COATED in 1 BOTTLE (16729-217-16)	2017-02-09	0000-00-00	No	No	Current
16729-217-43	16729021743	100 in 1 BOX, UNIT-DOSE					Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
SERTRALINE HYDROCHLORIDE	St. Mary's Medical Park Pharmacy	2026-06-02	HUMAN PRESCRIPTION DRUG LABEL	5
SERTRALINE HYDROCHLORIDE	Bryant Ranch Prepack	2026-05-22	HUMAN PRESCRIPTION DRUG LABEL	103
SERTRALINE HYDROCHLORIDE	Accord Healthcare, Inc. \| Intas Pharmaceuticals Ltd	2025-12-17	HUMAN PRESCRIPTION DRUG LABEL	19
SERTRALINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	2025-09-19	HUMAN PRESCRIPTION DRUG LABEL	4
SERTRALINE HYDROCHLORIDE	Quality Care Products, LLC	2024-12-18	HUMAN PRESCRIPTION DRUG LABEL	4
SERTRALINE HYDROCHLORIDE	A-S Medication Solutions	2023-05-10	HUMAN PRESCRIPTION DRUG LABEL	12
Sertraline Hydrochloride Tablets USP	NuCare Pharmaceuticals,Inc.	2022-07-05	HUMAN PRESCRIPTION DRUG LABEL	5
SERTRALINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	2022-06-24	HUMAN PRESCRIPTION DRUG LABEL	2
SERTRALINE HYDROCHLORIDE	RPK Pharmaceuticals, Inc.	2022-03-30	HUMAN PRESCRIPTION DRUG LABEL	1
SERTRALINE HYDROCHLORIDE	REMEDYREPACK INC.	2021-09-27	HUMAN PRESCRIPTION DRUG LABEL	3
SERTRALINE HYDROCHLORIDE	Unit Dose Services	2021-05-20	HUMAN PRESCRIPTION DRUG LABEL	5
SERTRALINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	2020-09-16	HUMAN PRESCRIPTION DRUG LABEL	3
Sertraline Hydrochloride Tablets USP	Proficient Rx LP	2019-11-01	HUMAN PRESCRIPTION DRUG LABEL	3
Sertraline Hydrochloride Tablets USP	NuCare Pharmaceuticals, Inc.	2017-07-11	HUMAN PRESCRIPTION DRUG LABEL	1