Sertraline Hydrochloride

Product NDC: 65862-011
Requested package NDC: 65862-011-59
11-digit product format: 658620011
Labeler code: 65862
Product ID: 65862-011_50d67885-52a9-49a4-9f2a-f82749747222
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sertraline Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Aurobindo Pharma Limited
Application: ANDA077206
Marketing category: ANDA
Marketing start: 2007-02-06
Substance: SERTRALINE HYDROCHLORIDE
Active strength: 25 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
unfinished package	package	65862-011	65862-011-59	UNFINISHED	Active or certified unfinished drug listing		2026-08-07

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 21 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 21:27 UTC · source 2025-12-05	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-08-26 23:59 UTC · source 2025-08-26	`1d862106b807…`	`00c93037cd84…`
2025-05-15 14:59 UTC · source 2025-05-14	`390b4c401c3f…`	`2c692c2daee3…`
2025-04-01 07:37 UTC · source 2025-03-31	`e30019b0c005…`	`a3f0b14938b7…`
2025-03-01 13:19 UTC · source 2025-02-28	`bbbc9f937eca…`	`946b9c97cf81…`
2025-02-27 05:24 UTC · source 2025-02-26	`f268b84574a6…`	`26285f5ac5df…`
2025-02-01 13:13 UTC · source 2025-01-31	`f764e8902f78…`	`92046438deef…`
2025-01-20 13:05 UTC · source 2025-01-17	`68b1e3bced9e…`	`98a755eb8bc6…`
2024-11-29 20:42 UTC · source 2024-11-29	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-09 02:36 UTC · source 2024-11-08	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-10-09 02:27 UTC · source 2024-10-08	`27f29a85d7e4…`	`1372111e901f…`
2024-07-10 04:00 UTC · source 2024-07-09	`8d62ce987f31…`	`9fe9ef23e30d…`
2024-05-28 21:11 UTC · source 2024-05-28	`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-15 03:51 UTC · source 2024-05-14	`50b4072663b7…`	`eae3003ed65e…`
2022-04-09 23:13 UTC · source 2022-04-08	`906f6e251498…`	`bf70b80e44f0…`
2021-12-27 23:28 UTC · source 2021-12-27	`6db9cb8d1e19…`	`3449e1ec5b70…`
2021-02-18 23:40 UTC · source 2021-02-18	`8fc7167e32ce…`	`e96bbc724034…`
2020-12-18 03:04 UTC · source 2020-12-17	`4184dd79f89f…`	`545327b3e20f…`
2020-06-10 20:45 UTC · source 2020-06-10	`4bd3596a7b87…`	`5c64c6f6865f…`
2019-12-08 06:16 UTC · source 2019-12-05	`263afe128892…`	`91768de4ddbe…`
2019-06-01 22:24 UTC · source 2019-05-30	`5b2001dcd8f5…`	`54b53d4dc9e4…`

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.

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	A077206-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2007-02-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077206-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2007-02-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077206-003	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	A077206-001	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	A077206-002	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	A077206-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2007-02-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077206-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2007-02-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077206-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2007-02-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077206-003	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	A077206-001	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	A077206-002	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	A077206-003	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	A077206-001	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	A077206-002	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	A077206-003	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	A077206-001	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	A077206-002	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	A077206-003	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	A077206-001	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	A077206-002	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	A077206-003	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	A077206-001	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	A077206-002	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	A077206-003	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	A077206-001	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	A077206-002	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	A077206-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2007-02-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077206-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2007-02-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077206-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2007-02-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077206-003	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	A077206-001	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	A077206-002	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	A077206-003	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	A077206-001	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	A077206-002	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	A077206-003	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	A077206-001	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	A077206-002	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	A077206-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2007-02-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077206-001	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	A077206-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077206-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077206-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077206-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077206-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077206-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077206-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077206-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077206-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077206-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077206-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077206-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077206-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077206-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077206-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077206-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077206-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077206-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077206-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077206-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077206-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077206-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077206-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077206-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077206-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077206-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077206-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077206-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077206-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077206-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077206-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077206-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077206-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077206-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077206-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077206-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077206-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077206-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077206-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077206-001	AB	1	`8072bd15b7f6…`

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	25 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
39a85db1-9e59-4ab0-9e18-36757f019faa	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
65862-011-01	Sertraline Hydrochloride	100 in 1 BOTTLE	TABLET, FILM COATED	100	30
65862-011-05	Sertraline Hydrochloride	500 in 1 BOTTLE	TABLET, FILM COATED	500	30
65862-011-30	Sertraline Hydrochloride	30 in 1 BOTTLE	TABLET, FILM COATED	30	30
65862-011-50	Sertraline Hydrochloride	50 in 1 BOTTLE	TABLET, FILM COATED	50	30
65862-011-51	Sertraline Hydrochloride	5000 in 1 BOTTLE	TABLET, FILM COATED	5000	30
65862-011-60	Sertraline Hydrochloride	60 in 1 BOTTLE	TABLET, FILM COATED	60	30
65862-011-90	Sertraline Hydrochloride	90 in 1 BOTTLE	TABLET, FILM COATED	90	30
65862-011-99	Sertraline Hydrochloride	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	30

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65862-011-01	EA - Each	65862-011	1e7bb4a8-d241-4036-bfb2-51d59c4c6fd9	1	2012-07-24
65862-011-05	EA - Each	65862-011	9449c2ef-0eee-48fd-a99c-1088c72edc7c	1	2012-07-24
65862-011-30	EA - Each	65862-011	98d86e4d-14b7-4d3e-9381-8eea7a08a762	1	2012-07-24
65862-011-90	EA - Each	65862-011	036d62be-4035-466e-9753-6fdf31875796	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SERTRALINE HYDROCHLORIDE	ACTIVE INGREDIENT	UTI8907Y6X	SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	15
SERTRALINE	ACTIVE MOIETY	QUC7NX6WMB	SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	15
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	15
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	15
DIBASIC CALCIUM PHOSPHATE DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	15
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	15
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	15
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	15
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	15
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	15
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	15
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	15
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	15
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	15
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	15
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65862-011	SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	30	Current NDC, Legacy NDC, 8 package rows	20240210_39a85db1-9e59-4ab0-9e18-36757f019faa.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 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
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

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
312940	sertraline HCl 25 MG Oral Tablet	PSN	5c6c817e-a555-4f55-837d-94458787fcb6	102
312940	sertraline 25 MG Oral Tablet	SCD	5c6c817e-a555-4f55-837d-94458787fcb6	102
312940	sertraline (as sertraline HCl) 25 MG Oral Tablet	SY	5c6c817e-a555-4f55-837d-94458787fcb6	102
312938	sertraline HCl 100 MG Oral Tablet	PSN	286b429d-62b9-4ca8-a243-de3f619315bf	37
312940	sertraline HCl 25 MG Oral Tablet	PSN	286b429d-62b9-4ca8-a243-de3f619315bf	37
312941	sertraline HCl 50 MG Oral Tablet	PSN	286b429d-62b9-4ca8-a243-de3f619315bf	37
312938	sertraline 100 MG Oral Tablet	SCD	286b429d-62b9-4ca8-a243-de3f619315bf	37
312940	sertraline 25 MG Oral Tablet	SCD	286b429d-62b9-4ca8-a243-de3f619315bf	37
312941	sertraline 50 MG Oral Tablet	SCD	286b429d-62b9-4ca8-a243-de3f619315bf	37
312938	sertraline (as sertraline HCl) 100 MG Oral Tablet	SY	286b429d-62b9-4ca8-a243-de3f619315bf	37
312940	sertraline (as sertraline HCl) 25 MG Oral Tablet	SY	286b429d-62b9-4ca8-a243-de3f619315bf	37
312941	sertraline (as sertraline HCl) 50 MG Oral Tablet	SY	286b429d-62b9-4ca8-a243-de3f619315bf	37
312940	sertraline HCl 25 MG Oral Tablet	PSN	0e5a7b02-3972-47f0-9f49-e958d792beac	32
312940	sertraline 25 MG Oral Tablet	SCD	0e5a7b02-3972-47f0-9f49-e958d792beac	32
312940	sertraline (as sertraline HCl) 25 MG Oral Tablet	SY	0e5a7b02-3972-47f0-9f49-e958d792beac	32
312938	sertraline HCl 100 MG Oral Tablet	PSN	39a85db1-9e59-4ab0-9e18-36757f019faa	30
312940	sertraline HCl 25 MG Oral Tablet	PSN	39a85db1-9e59-4ab0-9e18-36757f019faa	30
312941	sertraline HCl 50 MG Oral Tablet	PSN	39a85db1-9e59-4ab0-9e18-36757f019faa	30
312938	sertraline 100 MG Oral Tablet	SCD	39a85db1-9e59-4ab0-9e18-36757f019faa	30
312940	sertraline 25 MG Oral Tablet	SCD	39a85db1-9e59-4ab0-9e18-36757f019faa	30
312941	sertraline 50 MG Oral Tablet	SCD	39a85db1-9e59-4ab0-9e18-36757f019faa	30
312938	sertraline (as sertraline HCl) 100 MG Oral Tablet	SY	39a85db1-9e59-4ab0-9e18-36757f019faa	30
312940	sertraline (as sertraline HCl) 25 MG Oral Tablet	SY	39a85db1-9e59-4ab0-9e18-36757f019faa	30
312941	sertraline (as sertraline HCl) 50 MG Oral Tablet	SY	39a85db1-9e59-4ab0-9e18-36757f019faa	30
312940	sertraline HCl 25 MG Oral Tablet	PSN	575da603-b038-421f-9894-6796d9ac33cc	15
312940	sertraline 25 MG Oral Tablet	SCD	575da603-b038-421f-9894-6796d9ac33cc	15
312940	sertraline (as sertraline HCl) 25 MG Oral Tablet	SY	575da603-b038-421f-9894-6796d9ac33cc	15
312940	sertraline HCl 25 MG Oral Tablet	PSN	b559c20d-70be-41e7-acfb-262ffc3ea878	9
312940	sertraline 25 MG Oral Tablet	SCD	b559c20d-70be-41e7-acfb-262ffc3ea878	9
312940	sertraline (as sertraline HCl) 25 MG Oral Tablet	SY	b559c20d-70be-41e7-acfb-262ffc3ea878	9
312940	sertraline HCl 25 MG Oral Tablet	PSN	6dd71a5b-1923-54fb-e053-2991aa0a619e	5
312940	sertraline 25 MG Oral Tablet	SCD	6dd71a5b-1923-54fb-e053-2991aa0a619e	5
312940	sertraline (as sertraline HCl) 25 MG Oral Tablet	SY	6dd71a5b-1923-54fb-e053-2991aa0a619e	5
312938	sertraline HCl 100 MG Oral Tablet	PSN	06c47a1b-e41a-457d-8a4f-863cece11d1c	4
312940	sertraline HCl 25 MG Oral Tablet	PSN	06c47a1b-e41a-457d-8a4f-863cece11d1c	4
312941	sertraline HCl 50 MG Oral Tablet	PSN	06c47a1b-e41a-457d-8a4f-863cece11d1c	4
312938	sertraline 100 MG Oral Tablet	SCD	06c47a1b-e41a-457d-8a4f-863cece11d1c	4
312940	sertraline 25 MG Oral Tablet	SCD	06c47a1b-e41a-457d-8a4f-863cece11d1c	4
312941	sertraline 50 MG Oral Tablet	SCD	06c47a1b-e41a-457d-8a4f-863cece11d1c	4
312938	sertraline (as sertraline HCl) 100 MG Oral Tablet	SY	06c47a1b-e41a-457d-8a4f-863cece11d1c	4
312940	sertraline (as sertraline HCl) 25 MG Oral Tablet	SY	06c47a1b-e41a-457d-8a4f-863cece11d1c	4
312941	sertraline (as sertraline HCl) 50 MG Oral Tablet	SY	06c47a1b-e41a-457d-8a4f-863cece11d1c	4
312940	sertraline HCl 25 MG Oral Tablet	PSN	b6f306d9-009e-438e-9672-d9f359e4d0da	3
312940	sertraline 25 MG Oral Tablet	SCD	b6f306d9-009e-438e-9672-d9f359e4d0da	3
312940	sertraline (as sertraline HCl) 25 MG Oral Tablet	SY	b6f306d9-009e-438e-9672-d9f359e4d0da	3
312938	sertraline HCl 100 MG Oral Tablet	PSN	e25a13c3-a173-4cc3-99d3-0be43abbc498	2
312940	sertraline HCl 25 MG Oral Tablet	PSN	e25a13c3-a173-4cc3-99d3-0be43abbc498	2
312940	sertraline HCl 25 MG Oral Tablet	PSN	bc1abb84-4160-1aee-e053-2995a90af27c	2
312940	sertraline HCl 25 MG Oral Tablet	PSN	ba201164-f6f7-4779-87a3-62780f332113	2
312941	sertraline HCl 50 MG Oral Tablet	PSN	e25a13c3-a173-4cc3-99d3-0be43abbc498	2
312938	sertraline 100 MG Oral Tablet	SCD	e25a13c3-a173-4cc3-99d3-0be43abbc498	2
312940	sertraline 25 MG Oral Tablet	SCD	ba201164-f6f7-4779-87a3-62780f332113	2
312940	sertraline 25 MG Oral Tablet	SCD	bc1abb84-4160-1aee-e053-2995a90af27c	2
312940	sertraline 25 MG Oral Tablet	SCD	e25a13c3-a173-4cc3-99d3-0be43abbc498	2
312941	sertraline 50 MG Oral Tablet	SCD	e25a13c3-a173-4cc3-99d3-0be43abbc498	2
312938	sertraline (as sertraline HCl) 100 MG Oral Tablet	SY	e25a13c3-a173-4cc3-99d3-0be43abbc498	2
312940	sertraline (as sertraline HCl) 25 MG Oral Tablet	SY	bc1abb84-4160-1aee-e053-2995a90af27c	2
312940	sertraline (as sertraline HCl) 25 MG Oral Tablet	SY	e25a13c3-a173-4cc3-99d3-0be43abbc498	2
312940	sertraline (as sertraline HCl) 25 MG Oral Tablet	SY	ba201164-f6f7-4779-87a3-62780f332113	2
312941	sertraline (as sertraline HCl) 50 MG Oral Tablet	SY	e25a13c3-a173-4cc3-99d3-0be43abbc498	2
312940	sertraline HCl 25 MG Oral Tablet	PSN	8f5a71b2-2821-46a0-ac65-28d9b2db73ec	1
312940	sertraline 25 MG Oral Tablet	SCD	8f5a71b2-2821-46a0-ac65-28d9b2db73ec	1
312940	sertraline (as sertraline HCl) 25 MG Oral Tablet	SY	8f5a71b2-2821-46a0-ac65-28d9b2db73ec	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Status
65862-011-59	65862001159	5000 TABLET, FILM COATED in 1 BAG (65862-011-59)	06-FEB-07	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sertraline Hydrochloride	REMEDYREPACK INC.	2026-06-25	HUMAN PRESCRIPTION DRUG LABEL	16
Sertraline Hydrochloride	Preferred Pharmaceuticals Inc.	2025-10-17	HUMAN PRESCRIPTION DRUG LABEL	1
Sertraline Hydrochloride	Preferred Pharmaceuticals Inc.	2025-09-18	HUMAN PRESCRIPTION DRUG LABEL	9
Sertraline Hydrochloride	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2025-02-12	HUMAN PRESCRIPTION DRUG LABEL	2
Sertraline Hydrochloride	PD-Rx Pharmaceuticals, Inc.	2025-01-14	HUMAN PRESCRIPTION DRUG LABEL	32
Sertraline Hydrochloride	Coupler LLC	2024-11-08	HUMAN PRESCRIPTION DRUG LABEL	2
Sertraline Hydrochloride	NuCare Pharmaceuticals,Inc.	2024-06-10	HUMAN PRESCRIPTION DRUG LABEL	5
Sertraline Hydrochloride	Bryant Ranch Prepack	2024-05-22	HUMAN PRESCRIPTION DRUG LABEL	102
Sertraline Hydrochloride	Aurobindo Pharma Limited \| APL HEALTHCARE LIMITED	2024-02-09	Human Prescription Drug Label	30
Sertraline Hydrochloride	A-S Medication Solutions	2023-09-10	Human Prescription Drug Label	37
Sertraline Hydrochloride	RPK Pharmaceuticals, Inc.	2023-06-07	Human Prescription Drug Label	3
Sertraline Hydrochloride	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2023-01-01	HUMAN PRESCRIPTION DRUG LABEL	1
Sertraline Hydrochloride	Proficient Rx LP	2022-06-01	HUMAN PRESCRIPTION DRUG LABEL	2
Sertraline Hydrochloride	NuCare Pharmaceuticals,Inc.	2022-01-20	HUMAN PRESCRIPTION DRUG LABEL	4
Sertraline Hydrochloride	Bryant Ranch Prepack	2022-01-18	HUMAN PRESCRIPTION DRUG LABEL	2
Sertraline Hydrochloride	Bryant Ranch Prepack	2021-03-09	Human Prescription Drug Label	7
Sertraline Hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	2020-06-25	Human Prescription Drug Label	4
Sertraline Hydrochloride	REMEDYREPACK INC.	2019-06-06	HUMAN PRESCRIPTION DRUG LABEL	5
Sertraline Hydrochloride	Unit Dose Services	2019-02-21	Human Prescription Drug Label	4
Sertraline Hydrochloride	St. Mary's Medical Park Pharmacy \| Aurobindo Pharma Limited	2018-11-16	HUMAN PRESCRIPTION DRUG LABEL	3
Sertraline Hydrochloride	NuCare Pharmaceuticals, Inc.	2017-03-28	HUMAN PRESCRIPTION DRUG LABEL	1