SERTRALINE

Product NDC: 76282-213
Requested package NDC: 76282-213-90
11-digit product format: 762820213
Labeler code: 76282
Product ID: 76282-213_5c34aa64-3f25-4d6e-8fbb-98aa3688f72d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sertraline
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Exelan Pharmaceuticals, Inc.
Application: ANDA077397
Marketing category: ANDA
Marketing start: 2012-08-20
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

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	76282-213	76282-213-90	I	Inactivated by FDA		2026-08-10

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
A077397-001	SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2007-02-06
A077397-002	SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2007-02-06
A077397-003	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
A077397-001	AB
A077397-002	AB
A077397-003	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	A077397-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2007-02-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077397-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2007-02-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077397-003	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	A077397-001	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	A077397-002	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	A077397-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2007-02-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077397-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2007-02-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077397-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2007-02-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077397-003	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	A077397-001	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	A077397-002	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	A077397-003	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	A077397-001	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	A077397-002	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	A077397-003	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	A077397-001	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	A077397-002	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	A077397-003	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	A077397-001	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	A077397-002	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	A077397-003	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	A077397-001	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	A077397-002	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	A077397-003	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	A077397-001	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	A077397-002	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	A077397-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2007-02-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077397-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2007-02-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077397-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2007-02-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077397-003	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	A077397-001	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	A077397-002	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	A077397-003	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	A077397-001	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	A077397-002	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	A077397-003	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	A077397-001	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	A077397-002	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	A077397-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2007-02-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077397-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2007-02-06	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	A077397-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077397-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077397-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077397-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077397-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077397-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077397-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077397-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077397-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077397-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077397-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077397-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077397-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077397-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077397-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077397-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077397-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077397-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077397-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077397-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077397-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077397-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077397-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077397-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077397-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077397-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077397-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077397-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077397-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077397-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077397-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077397-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077397-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077397-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077397-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077397-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077397-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077397-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077397-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077397-001	AB	1	`8072bd15b7f6…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
351abe41-466c-4dd8-840a-0fdb68318bd5	Product name	1	20230316
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
76282-213-01	SERTRALINE	100 in 1 BOTTLE	TABLET, FILM COATED	100	8
76282-213-05	SERTRALINE	500 in 1 BOTTLE	TABLET, FILM COATED	500	8
76282-213-18	SERTRALINE	180 in 1 BOTTLE	TABLET, FILM COATED	180	8
76282-213-30	SERTRALINE	30 in 1 BOTTLE	TABLET, FILM COATED	30	8
76282-213-60	SERTRALINE	60 in 1 BOTTLE	TABLET, FILM COATED	60	8
76282-213-90	SERTRALINE	90 in 1 BOTTLE	TABLET, FILM COATED	90	8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
76282-213-01	EA - Each	76282-213	6300ca1f-a6ee-49eb-ba3a-b82d90791ff8	1	2017-10-13
76282-213-05	EA - Each	76282-213	b1878f44-9f84-4d28-b36c-ca159dc05c7f	1	2013-02-13
76282-213-18	EA - Each	76282-213	e0303ebf-92df-4429-9634-cb245c6be85c	1	2017-10-13
76282-213-30	EA - Each	76282-213	b6c194c9-72fe-4480-93e0-b2ddd7c11747	1	2013-02-13
76282-213-60	EA - Each	76282-213	22e524bb-73c6-4920-bf2b-216bbadfc8ca	1	2017-10-13
76282-213-90	EA - Each	76282-213	da79f7e0-785f-4010-8761-4a3e2f5e00b9	1	2016-05-16

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SERTRALINE HYDROCHLORIDE	ACTIVE INGREDIENT	UTI8907Y6X	SERTRALINE TABLET, FILM COATED [EXELAN PHARMACEUTICALS, INC.]	1
SERTRALINE HYDROCHLORIDE	ACTIVE INGREDIENT	UTI8907Y6X	SERTRALINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
SERTRALINE	ACTIVE MOIETY	QUC7NX6WMB	SERTRALINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
SERTRALINE	ACTIVE MOIETY	QUC7NX6WMB	SERTRALINE TABLET, FILM COATED [EXELAN PHARMACEUTICALS, INC.]	1
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	SERTRALINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	SERTRALINE TABLET, FILM COATED [EXELAN PHARMACEUTICALS, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SERTRALINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SERTRALINE TABLET, FILM COATED [EXELAN PHARMACEUTICALS, INC.]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	SERTRALINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	SERTRALINE TABLET, FILM COATED [EXELAN PHARMACEUTICALS, INC.]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	SERTRALINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	SERTRALINE TABLET, FILM COATED [EXELAN PHARMACEUTICALS, INC.]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	SERTRALINE TABLET, FILM COATED [EXELAN PHARMACEUTICALS, INC.]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	SERTRALINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	SERTRALINE TABLET, FILM COATED [EXELAN PHARMACEUTICALS, INC.]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	SERTRALINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	SERTRALINE TABLET, FILM COATED [EXELAN PHARMACEUTICALS, INC.]	1
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	SERTRALINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	SERTRALINE TABLET, FILM COATED [EXELAN PHARMACEUTICALS, INC.]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	SERTRALINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
INDIGOTINDISULFONATE SODIUM	INACTIVE INGREDIENT	D3741U8K7L	SERTRALINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
INDIGOTINDISULFONATE SODIUM	INACTIVE INGREDIENT	D3741U8K7L	SERTRALINE TABLET, FILM COATED [EXELAN PHARMACEUTICALS, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SERTRALINE TABLET, FILM COATED [EXELAN PHARMACEUTICALS, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SERTRALINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	SERTRALINE TABLET, FILM COATED [EXELAN PHARMACEUTICALS, INC.]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	SERTRALINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	SERTRALINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	SERTRALINE TABLET, FILM COATED [EXELAN PHARMACEUTICALS, INC.]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	SERTRALINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	SERTRALINE TABLET, FILM COATED [EXELAN PHARMACEUTICALS, INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SERTRALINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SERTRALINE TABLET, FILM COATED [EXELAN PHARMACEUTICALS, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76282-213	SERTRALINE (SERTRALINE) TABLET, FILM COATED [EXELAN PHARMACEUTICALS, INC.]	8	Current NDC, Legacy NDC, 6 package rows	20231118_2dac437f-b5ef-42dd-aa0b-1f4b9b45ef43.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 · 19 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Coupler LLC	56442b06-c135-a035-e063-6394a90a171b	2026-07-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077397 application number: ANDA077397
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Legacy Pharmaceutical Packaging, LLC	bd86b293-dab9-4d37-95eb-2bffca335d16	2026-03-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077397 application number: ANDA077397
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Quallent Pharmaceuticals Health LLC	61835f25-bfe4-49ac-9dbf-3d6387866e78	2026-02-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077397 application number: ANDA077397
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Cipla USA Inc.	cf71d1b9-5ebb-429f-a07f-a87cd168250f	2026-02-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077397 application number: ANDA077397
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Northwind Health Company, LLC	ab30b0a4-6696-19da-e053-2995a90a29aa	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077397 application number: ANDA077397
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Cardinal Health 107, LLC	7e5e76cf-2fda-4f9d-bcbf-f77b1f188ee6	2025-10-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077397 application number: ANDA077397
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	52c88667-c67e-4d42-b319-afb354713b1e	2025-10-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077397 application number: ANDA077397
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	adfcc867-1b6e-4698-94b6-2b4190c4ba3d	2025-10-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077397 application number: ANDA077397
SERTRALINE	SERTRALINE	Aphena Pharma Solutions - Tennessee, LLC	1548faf9-8625-f871-e063-6394a90a931f	2025-07-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077397 application number: ANDA077397
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	REMEDYREPACK INC.	7d598f1a-6c76-458a-a155-7a6a0743a2d3	2025-05-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077397 application number: ANDA077397
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	30b94d67-0000-a045-e063-6394a90ade32	2025-03-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077397 application number: ANDA077397
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	American Health Packaging	4e09f580-d612-416c-a4a4-79a4411845b2	2024-11-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077397 application number: ANDA077397
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	7cadc747-5606-8efe-e053-2991aa0a1d8f	2024-06-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077397 application number: ANDA077397
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Bryant Ranch Prepack	22c4b114-5f70-4c64-aa7f-b4169729b847	2024-04-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077397 application number: ANDA077397
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Bryant Ranch Prepack	9bcef7ef-4e2f-4ab9-9c0f-f4956bfdd71b	2024-04-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077397 application number: ANDA077397
SERTRALINE	SERTRALINE	Aphena Pharma Solutions - Tennessee, LLC	7be6a62e-0e85-47c8-8793-b41c51c2557f	2024-03-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077397 application number: ANDA077397
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Proficient Rx LP	787a683a-091c-4908-a643-ecbc8fd467eb	2020-02-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077397 application number: ANDA077397
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Proficient Rx LP	00179766-980b-44b0-99d3-1fee2bb27e37	2019-11-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077397 application number: ANDA077397
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Proficient Rx LP	551d5946-00df-4608-96a2-b29f0ef93ba0	2019-11-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077397 application number: ANDA077397

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
UTI8907Y6X	SERTRALINE HYDROCHLORIDE	79559-97-0	SERTRALINE HYDROCHLORIDE
QUC7NX6WMB	SERTRALINE	79617-96-2	Sertraline

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
312938	sertraline HCl 100 MG Oral Tablet	PSN	2dac437f-b5ef-42dd-aa0b-1f4b9b45ef43	8
312940	sertraline HCl 25 MG Oral Tablet	PSN	2dac437f-b5ef-42dd-aa0b-1f4b9b45ef43	8
312941	sertraline HCl 50 MG Oral Tablet	PSN	2dac437f-b5ef-42dd-aa0b-1f4b9b45ef43	8
312938	sertraline 100 MG Oral Tablet	SCD	2dac437f-b5ef-42dd-aa0b-1f4b9b45ef43	8
312940	sertraline 25 MG Oral Tablet	SCD	2dac437f-b5ef-42dd-aa0b-1f4b9b45ef43	8
312941	sertraline 50 MG Oral Tablet	SCD	2dac437f-b5ef-42dd-aa0b-1f4b9b45ef43	8
312938	sertraline (as sertraline HCl) 100 MG Oral Tablet	SY	2dac437f-b5ef-42dd-aa0b-1f4b9b45ef43	8
312940	sertraline (as sertraline HCl) 25 MG Oral Tablet	SY	2dac437f-b5ef-42dd-aa0b-1f4b9b45ef43	8
312941	sertraline (as sertraline HCl) 50 MG Oral Tablet	SY	2dac437f-b5ef-42dd-aa0b-1f4b9b45ef43	8
312941	sertraline HCl 50 MG Oral Tablet	PSN	1548faf9-8625-f871-e063-6394a90a931f	4
312941	sertraline 50 MG Oral Tablet	SCD	1548faf9-8625-f871-e063-6394a90a931f	4
312941	sertraline (as sertraline HCl) 50 MG Oral Tablet	SY	1548faf9-8625-f871-e063-6394a90a931f	4
312938	sertraline HCl 100 MG Oral Tablet	PSN	c01ed291-3c4f-4285-b54d-d15d39327b21	2
312940	sertraline HCl 25 MG Oral Tablet	PSN	c01ed291-3c4f-4285-b54d-d15d39327b21	2
312941	sertraline HCl 50 MG Oral Tablet	PSN	c01ed291-3c4f-4285-b54d-d15d39327b21	2
312938	sertraline 100 MG Oral Tablet	SCD	c01ed291-3c4f-4285-b54d-d15d39327b21	2
312940	sertraline 25 MG Oral Tablet	SCD	c01ed291-3c4f-4285-b54d-d15d39327b21	2
312941	sertraline 50 MG Oral Tablet	SCD	c01ed291-3c4f-4285-b54d-d15d39327b21	2
312938	sertraline (as sertraline HCl) 100 MG Oral Tablet	SY	c01ed291-3c4f-4285-b54d-d15d39327b21	2
312940	sertraline (as sertraline HCl) 25 MG Oral Tablet	SY	c01ed291-3c4f-4285-b54d-d15d39327b21	2
312941	sertraline (as sertraline HCl) 50 MG Oral Tablet	SY	c01ed291-3c4f-4285-b54d-d15d39327b21	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
76282-213-90	76282021390	90 TABLET, FILM COATED in 1 BOTTLE (76282-213-90)	2012-08-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
SERTRALINE	Aphena Pharma Solutions - Tennessee, LLC	2025-07-21	HUMAN PRESCRIPTION DRUG LABEL	4
SERTRALINE	Exelan Pharmaceuticals, Inc. \| Invagen Pharmaceuticals, Inc. \| Ascent Pharmaceuticals Inc. \| Legacy Pharmaceutical Packaging, LLC	2023-09-01	HUMAN PRESCRIPTION DRUG LABEL	8
Sertraline Tablets, USP 25 mg, 50 mg and 100 mg Rx Only	Aphena Pharma Solutions - Tennessee, LLC	2019-12-19	HUMAN PRESCRIPTION DRUG LABEL	2