Sertraline Hydrochloride

Product NDC: 59115-054
11-digit product format: 591150054
Labeler code: 59115
Product ID: 59115-054_ece847e7-955f-46ab-ace4-eac58d4d9ac4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: sertraline hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Hikma Pharmaceutical
Application: ANDA077864
Marketing category: ANDA
Marketing start: 2009-08-10
Marketing end: 0000-00-00
Substance: SERTRALINE HYDROCHLORIDE
Active strength: 50 mg/1
Pharmacologic classes: Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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	Approval date
A077864-001	SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2009-08-10
A077864-002	SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	2009-08-10
A077864-003	SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2009-08-10

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 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A077864-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2009-08-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077864-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	2009-08-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077864-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2009-08-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077864-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2009-08-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077864-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	2009-08-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077864-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2009-08-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077864-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2009-08-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077864-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	2009-08-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077864-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2009-08-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077864-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2009-08-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077864-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	2009-08-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077864-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2009-08-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077864-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2009-08-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077864-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	2009-08-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077864-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2009-08-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077864-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2009-08-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077864-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	2009-08-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077864-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2009-08-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077864-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2009-08-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077864-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	2009-08-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077864-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2009-08-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077864-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2009-08-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077864-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	2009-08-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077864-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2009-08-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077864-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2009-08-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077864-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	2009-08-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077864-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2009-08-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077864-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2009-08-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077864-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	2009-08-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077864-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2009-08-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077864-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2009-08-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077864-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	2009-08-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077864-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2009-08-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077864-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2009-08-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077864-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	2009-08-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077864-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2009-08-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077864-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2009-08-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077864-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	2009-08-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077864-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2009-08-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077864-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2009-08-10	`301d65b070ca…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SERTRALINE HYDROCHLORIDE	ACTIVE INGREDIENT	UTI8907Y6X	SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [HIKMA PHARMACEUTICAL]	3
SERTRALINE	ACTIVE MOIETY	QUC7NX6WMB	SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [HIKMA PHARMACEUTICAL]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [HIKMA PHARMACEUTICAL]	3
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [HIKMA PHARMACEUTICAL]	3
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [HIKMA PHARMACEUTICAL]	3
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [HIKMA PHARMACEUTICAL]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [HIKMA PHARMACEUTICAL]	3
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [HIKMA PHARMACEUTICAL]	3
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [HIKMA PHARMACEUTICAL]	3
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [HIKMA PHARMACEUTICAL]	3
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [HIKMA PHARMACEUTICAL]	3
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [HIKMA PHARMACEUTICAL]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [HIKMA PHARMACEUTICAL]	3

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
UTI8907Y6X	SERTRALINE HYDROCHLORIDE	79559-97-0	SERTRALINE HYDROCHLORIDE

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sertraline Hydrochloride Tablets Rx Only Rev. 09/11	Hikma Pharmaceutical	2019-08-26	HUMAN PRESCRIPTION DRUG LABEL	6

Sertraline Hydrochloride

Orange Book products#

Observed Orange Book product history#

Reported adverse events (FAERS/openFDA)#

DailyMed Socrata Ingredients#

Related Records#

Related UNII Ingredients#

Related DailyMed Labels#